ID

35155

Beschreibung

Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Stichworte

Versionen (1)
  1. 20.02.19 20.02.19 -
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GlaxoSmithKline

Hochgeladen am

20. Februar 2019

DOI

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Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970

Englisch

Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Screening
Administrative Data
Beschreibung

Administrative Data

Site
Beschreibung

Study Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschreibung

Clinical trial participant

Datentyp

text

Alias
UMLS CUI [1]
C1997894
Subject No.
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Oropharyngeal Candidiasis Examination
Beschreibung

Oropharyngeal Candidiasis Examination

Alias
UMLS CUI-1
C0919659
UMLS CUI-2
C0582103
Does the subject have clinical evidence of oropharyngeal candidiasis?
Beschreibung

Oropharyngeal Candidiasis, Evidence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C3887511
Was a culture swab taken?
Beschreibung

Oropharyngeal Candidiasis, Taking of swab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C0563454
Result of culture swab
Beschreibung

Oropharyngeal Candidiasis, Taking of swab, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C0563454
UMLS CUI [1,3]
C1274040
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnic group

Datentyp

text

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Beschreibung

Check all that apply

Datentyp

text

Alias
UMLS CUI [1]
C3841890
Disease Duration
Beschreibung

Disease Duration

Alias
UMLS CUI-1
C0872146
Duration of COPD
Beschreibung

Select appropriate category

Datentyp

text

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0449238
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschreibung

Date of visit, Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Screen Failure
Beschreibung

Screen Failure

Alias
UMLS CUI-1
C1710476
Was this subject a screen failure?
Beschreibung

Trial Screen Failure

Datentyp

boolean

Alias
UMLS CUI [1]
C1710476
Screen failure date
Beschreibung

Trial Screen Failure, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Reason
Beschreibung

Trial Screen Failure, Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beschreibung

Eligibility Determination

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Type of Subject: outpatient
Beschreibung

Outpatients

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
Informed consent: Subjects must give their signed and dated written informed consent to participate.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Gender: Male or female subjects
Beschreibung

A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post- menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. However in questionable cases, a blood sample with FSH > 40 MIU/ml and estradiol < 40pg/ml (<140pmol/L) is confirmatory. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study-- screening to follow-up contact): - Complete abstinence from intercourse from screening until the follow-up contact; or - Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or - Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or - Injectable progestogen administered for at least 1 month prior to study medication administration; or - Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or - Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or - An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or - Estrogenic vaginal ring; or - Percutaneous contraceptive patches

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
Age: >=40 years of age at Screening (Visit 1)
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
Beschreibung

Chronic Obstructive Airway Disease, Diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0011900
Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day /20) x number of years smoked
Beschreibung

Tobacco Use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
Severity of Disease: Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of <=0.70 at Screening (Visit 1) Subjects with a measured post-albuterol/salbutamol FEV1 <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1) Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self- administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
Beschreibung

Chronic Obstructive Airway Disease, Severity of illness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0521117
History of Exacerbations: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable.
Beschreibung

COPD exacerbation, Medical History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0262926
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Beschreibung

Pregnancy, Breast Feeding, Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0032992
Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
Beschreibung

Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
α1-antitrypsin deficiency: Subjects with α-1 antitrypsin deficiency as the underlying cause of COPD
Beschreibung

alpha 1-Antitrypsin Deficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0221757
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Beschreibung

Respiration Disorders, Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0205394
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
Beschreibung

Lung excision

Datentyp

boolean

Alias
UMLS CUI [1]
C0396565
Chest X-ray: Chest X-ray (posteroanterior with lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. cardiomegaly, pleural effusion or scarring etc). All subjects will have a chest x- ray at Screening Visit 1 (or historical radiograph obtained within 2 weeks prior to screening) that will be over-read by a central vendor.
Beschreibung

Standard chest X-ray abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0436503
Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myaesthenia Gravis, etc).
Beschreibung

Pneumonia, Risk factors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0035648
A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
Beschreibung

COPD exacerbation, Unresolved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0443342
Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least >= 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
Beschreibung

Pneumonia, COPD exacerbation, Current

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0740304
UMLS CUI [1,3]
C0521116
Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e. pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Beschreibung

Disease, Other; Abnormality, Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0205394
Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
Beschreibung

Peptic Ulcer

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
Hypertension: Subjects with clinically significant hypertension that is uncontrolled
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta- agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
Beschreibung

Experimental drug, Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0020517
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
Beschreibung

Substance Use Disorders; Alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0085762
Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
Beschreibung

Pharmaceutical Preparations, Unable, Spirometry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0037981
Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study: Inhaled short-acting beta2- agonists: 4 hours (albuterol/salbutamol will be supplied for rescue during the study) Ipratropium/salbutamol combination product: 4 hours (note: stable doses of ipratropium alone or study- supplied salbutamol alone is allowed during the study but must be withheld 4 hours prior to each study visit) Inhaled Long acting beta- agonists (LABA): 48 hours Theophylline preparations: 48 hours Cromolyn and Nedocromil inhaler: 48 hours Zafirlukast, montelukast, zileuton: 48 hours ICS/LABA combination products: 48 hours Inhaled corticosteroids:48 hours Antibiotics: 48 hours (except for the short term treatment of an exacerbation or for short term treatment of other acute infections) Tiotropium: 1 week Systemic, Oral, parenteral, intra-articular corticosteroids: 30 days (oral corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, Nefazodone: 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/8 ounces) or one grapefruit per day Any other investigational drug: 30 days or 5 half lives whichever is longer
Beschreibung

Pharmaceutical Preparations, Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205394
Oxygen therapy: Subjects receiving treatment with long- term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary.
Beschreibung

Oxygen Therapy Care

Datentyp

boolean

Alias
UMLS CUI [1]
C0184633
Sleep apnea: Subjects with clinically significant sleep apnea who require the use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
Beschreibung

Sleep Apnea Syndromes

Datentyp

boolean

Alias
UMLS CUI [1]
C0037315
Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
Beschreibung

Pulmonary Rehabilitation

Datentyp

boolean

Alias
UMLS CUI [1]
C0199529
Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
Beschreibung

Non-compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0457432
Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
Beschreibung

Informed Consent, Validity, Equivocal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2349101
UMLS CUI [1,3]
C0332241
Prior use of study medication/other investigational drugs: Subjects who have previously been randomized in the Phase IIa (HZC111348) study or Phase III (i.e. HZC112206, HZC112207, HZC102871, HZC110946) studies. Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer
Beschreibung

Experimental drug, Previous; Investigational New Drugs, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0205156
Affiliation with investigator site: Study investigators, sub- investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study
Beschreibung

Clinical Investigators, Site, Affiliate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0205145
UMLS CUI [1,3]
C1510825
Exacerbation History
Beschreibung

Exacerbation History

Alias
UMLS CUI-1
C0740304
UMLS CUI-2
C0262926
Number of exacerbations in the last 12 months that were managed without oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
Beschreibung

COPD exacerbation, Medical History, Antibiotics and corticosteroids, No

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C3653724
UMLS CUI [1,4]
C1298908
Number of exacerbations in the last 12 months that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
Beschreibung

COPD exacerbation, Medical History, Antibiotics and corticosteroids

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C3653724
Number of exacerbations in the last 12 months that required hospitalisation
Beschreibung

COPD exacerbation, Medical History, Hospitalization

Datentyp

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0019993
COPD Type
Beschreibung

Check both if applicable.

Datentyp

text

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0332307
Investigator Signature
Beschreibung

Investigator Signature

Alias
UMLS CUI-1
C2346576
Is this casebook ready to sign?
Beschreibung

Investigator Signature

Datentyp

boolean

Alias
UMLS CUI [1]
C2346576
Electronically Transferred Lab Data
Beschreibung

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Date sample taken
Beschreibung

Laboratory Procedures, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Not done
Beschreibung

Laboratory Procedures, Sampling, Not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Medical Conditions
Beschreibung

Medical Conditions

Alias
UMLS CUI-1
C0012634
Coronary Artery Disease
Beschreibung

Coronary Artery Disease

Datentyp

text

Alias
UMLS CUI [1]
C1956346
Myocardial Infarction
Beschreibung

Myocardial Infarction

Datentyp

text

Alias
UMLS CUI [1]
C0027051
Arrhythmia
Beschreibung

Cardiac Arrhythmia

Datentyp

text

Alias
UMLS CUI [1]
C0003811
Congestive Heart Failure
Beschreibung

Congestive Heart Failure

Datentyp

text

Alias
UMLS CUI [1]
C0018802
Cushing's Syndrome
Beschreibung

Cushing Syndrome

Datentyp

text

Alias
UMLS CUI [1]
C0010481
Adrenal Suppression
Beschreibung

Adrenal Glands, Suppressed

Datentyp

text

Alias
UMLS CUI [1,1]
C0001625
UMLS CUI [1,2]
C1260953
Cataract
Beschreibung

Cataract

Datentyp

text

Alias
UMLS CUI [1]
C0086543
Glaucoma
Beschreibung

Glaucoma

Datentyp

text

Alias
UMLS CUI [1]
C0017601
Hypertension
Beschreibung

Hypertensive disease

Datentyp

text

Alias
UMLS CUI [1]
C0020538
Cerebrovascular accident
Beschreibung

Cerebrovascular accident

Datentyp

text

Alias
UMLS CUI [1]
C0038454
Hypercholesterolemia
Beschreibung

Hypercholesterolemia

Datentyp

text

Alias
UMLS CUI [1]
C0020443
Diabetes Mellitus
Beschreibung

Diabetes Mellitus

Datentyp

text

Alias
UMLS CUI [1]
C0011849
Osteoporosis
Beschreibung

Osteoporosis

Datentyp

text

Alias
UMLS CUI [1]
C0029456
Pneumonia
Beschreibung

Pneumonia

Datentyp

text

Alias
UMLS CUI [1]
C0032285
Chest X-Ray
Beschreibung

Chest X-Ray

Alias
UMLS CUI-1
C0039985
Date of x-ray
Beschreibung

Plain chest X-ray, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0011008
Was an infiltrate present?
Beschreibung

x-ray of chest: pulmonary infiltrate

Datentyp

text

Alias
UMLS CUI [1]
C2073654
Infiltrate unilateral or bilateral
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Bilateral, Unilateral

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C0238767
UMLS CUI [1,4]
C0205092
Characterization of infiltrate
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Characterization

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1880022
Right upper lobe involved with infiltrate
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Structure of right upper lobe of lung

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261074
Right middle lobe involved with infiltrate
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Structure of middle lobe of lung

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C0225757
Right lower lobe involved with infiltrate
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Structure of right lower lobe of lung

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261075
Left upper lobe involved with infiltrate
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Structure of left upper lobe of lung

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261076
Lingula involved with infiltrate
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Lingula of left lung

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C0225740
Left lower lobe involved with infiltrate
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Structure of left lower lobe of lung

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261077
Was a pleural effusion identified?
Beschreibung

Plain chest X-ray, Pleural effusion disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0032227
Present, specify Location
Beschreibung

Plain chest X-ray, Pleural effusion disorder, Location

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0032227
UMLS CUI [1,3]
C0450429
Lung findings atelectasis
Beschreibung

Plain chest X-ray, Atelectasis

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0004144
Lung findings mass?
Beschreibung

Plain chest X-ray, Lung mass

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0149726
Lung findings cardiomegaly?
Beschreibung

Plain chest X-ray, Cardiomegaly

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0018800
Was pulmonary edema identified?
Beschreibung

Plain chest X-ray, Pulmonary Edema

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0034063
Comment
Beschreibung

Plain chest X-ray, Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0947611
Previous Clinical Trial Participation
Beschreibung

Previous Clinical Trial Participation

Alias
UMLS CUI-1
C2348568
Did the subject participate in a previous Fluticasone Furoate/GW642444 clinical trial?
Beschreibung

Study Subject Participation Status, Investigational New Drugs

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
Rescreening of Subject
Beschreibung

Rescreening of Subject

Alias
UMLS CUI-1
C0220908
UMLS CUI-2
C0205341
Was the subject rescreened?
Beschreibung

Screening Procedure, Repeat

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0205341
Subject Status at Screening
Beschreibung

Subject Status at Screening

Alias
UMLS CUI-1
C0220908
UMLS CUI-2
C0449438
Was the subject a screen failure at the Screening visit?
Beschreibung

Screening procedure, Trial Screen Failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C1710476
Subject Identification
Beschreibung

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
History of Tobacco Use
Beschreibung

History of Tobacco Use

Alias
UMLS CUI-1
C0841002
What is the subject's history of smoking use?
Beschreibung

History of tobacco use

Datentyp

text

Alias
UMLS CUI [1]
C0841002
Former smoker, when did the subject last smoke?
Beschreibung

Tobacco use, Last, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
Average number of cigarettes smoked per day?
Beschreibung

number of cigarettes per day

Datentyp

integer

Maßeinheiten
  • cigarettes per day
Alias
UMLS CUI [1]
C3694146
cigarettes per day
Number of years during which the subject has smoked tobacco?
Beschreibung

Smoking, year, Count of entities

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
years
Number of pack years?
Beschreibung

Pack years

Datentyp

integer

Alias
UMLS CUI [1]
C1277691
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschreibung

Body Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure (systolic)
Beschreibung

Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (diastolic)
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Screening

1 Formulare
  1. StudyEvent: ODM
    1. Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Clinical trial participant
Item
Subject
text
C1997894 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Item Group
Oropharyngeal Candidiasis Examination
C0919659 (UMLS CUI-1)
C0582103 (UMLS CUI-2)
Oropharyngeal Candidiasis, Evidence
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Oropharyngeal Candidiasis, Taking of swab
Item
Was a culture swab taken?
boolean
C0919659 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
Item
Result of culture swab
text
C0919659 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Oropharyngeal Candidiasis, Taking of swab, Result
Code List
Result of culture swab
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (3)
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female - Record child-bearing potential (2)
CL Item
Female - Post-menopausal (3)
CL Item
Female - Sterile (of child-bearing age)  (4)
CL Item
Female - Potentially able to bear children (5)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnic group
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
text
C3841890 (UMLS CUI [1])
Your ancestry or national origin
Code List
Geographic Ancestry
CL Item
African American/African Heritage  (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander  (7)
CL Item
White - Arabic/North African Heritage  (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Disease Duration
C0872146 (UMLS CUI-1)
Chronic Obstructive Airway Disease, Duration
Item
Duration of COPD
text
C0024117 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Screen Failure
C1710476 (UMLS CUI-1)
Trial Screen Failure
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Trial Screen Failure, Date in time
Item
Screen failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Trial Screen Failure, Reason
Code List
Reason
CL Item
Did not meet inclusion/exclusion criteria  (1)
CL Item
Adverse Event (unspecified) (2)
CL Item
Investigator discretion, specify  (3)
CL Item
Withdrew consent, specify (4)
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Outpatients
Item
Type of Subject: outpatient
boolean
C0029921 (UMLS CUI [1])
Informed Consent
Item
Informed consent: Subjects must give their signed and dated written informed consent to participate.
boolean
C0021430 (UMLS CUI [1])
Gender
Item
Gender: Male or female subjects
boolean
C0079399 (UMLS CUI [1])
Age
Item
Age: >=40 years of age at Screening (Visit 1)
boolean
C0001779 (UMLS CUI [1])
Chronic Obstructive Airway Disease, Diagnosis
Item
COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
boolean
C0024117 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Tobacco Use
Item
Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day /20) x number of years smoked
boolean
C0543414 (UMLS CUI [1])
Chronic Obstructive Airway Disease, Severity of illness
Item
Severity of Disease: Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of <=0.70 at Screening (Visit 1) Subjects with a measured post-albuterol/salbutamol FEV1 <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1) Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self- administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
boolean
C0024117 (UMLS CUI [1,1])
C0521117 (UMLS CUI [1,2])
COPD exacerbation, Medical History
Item
History of Exacerbations: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable.
boolean
C0740304 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Pregnancy, Breast Feeding, Pregnancy, Planned
Item
Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0032992 (UMLS CUI [1,3])
Asthma
Item
Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
boolean
C0004096 (UMLS CUI [1])
alpha 1-Antitrypsin Deficiency
Item
α1-antitrypsin deficiency: Subjects with α-1 antitrypsin deficiency as the underlying cause of COPD
boolean
C0221757 (UMLS CUI [1])
Respiration Disorders, Other
Item
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
boolean
C0035204 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Lung excision
Item
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
boolean
C0396565 (UMLS CUI [1])
Standard chest X-ray abnormal
Item
Chest X-ray: Chest X-ray (posteroanterior with lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. cardiomegaly, pleural effusion or scarring etc). All subjects will have a chest x- ray at Screening Visit 1 (or historical radiograph obtained within 2 weeks prior to screening) that will be over-read by a central vendor.
boolean
C0436503 (UMLS CUI [1])
Pneumonia, Risk factors
Item
Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myaesthenia Gravis, etc).
boolean
C0032285 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
COPD exacerbation, Unresolved
Item
A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
boolean
C0740304 (UMLS CUI [1,1])
C0443342 (UMLS CUI [1,2])
Pneumonia, COPD exacerbation, Current
Item
Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least >= 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
boolean
C0032285 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Disease, Other; Abnormality, Other
Item
Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e. pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Peptic Ulcer
Item
Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
boolean
C0030920 (UMLS CUI [1])
Uncontrolled hypertension
Item
Hypertension: Subjects with clinically significant hypertension that is uncontrolled
boolean
C1868885 (UMLS CUI [1])
Malignant Neoplasms
Item
Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
boolean
C0006826 (UMLS CUI [1])
Experimental drug, Hypersensitivity
Item
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta- agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Substance Use Disorders; Alcohol abuse
Item
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
boolean
C0038586 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Pharmaceutical Preparations, Unable, Spirometry
Item
Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
boolean
C0013227 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,3])
Pharmaceutical Preparations, Other
Item
Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study: Inhaled short-acting beta2- agonists: 4 hours (albuterol/salbutamol will be supplied for rescue during the study) Ipratropium/salbutamol combination product: 4 hours (note: stable doses of ipratropium alone or study- supplied salbutamol alone is allowed during the study but must be withheld 4 hours prior to each study visit) Inhaled Long acting beta- agonists (LABA): 48 hours Theophylline preparations: 48 hours Cromolyn and Nedocromil inhaler: 48 hours Zafirlukast, montelukast, zileuton: 48 hours ICS/LABA combination products: 48 hours Inhaled corticosteroids:48 hours Antibiotics: 48 hours (except for the short term treatment of an exacerbation or for short term treatment of other acute infections) Tiotropium: 1 week Systemic, Oral, parenteral, intra-articular corticosteroids: 30 days (oral corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, Nefazodone: 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/8 ounces) or one grapefruit per day Any other investigational drug: 30 days or 5 half lives whichever is longer
boolean
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Oxygen Therapy Care
Item
Oxygen therapy: Subjects receiving treatment with long- term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary.
boolean
C0184633 (UMLS CUI [1])
Sleep Apnea Syndromes
Item
Sleep apnea: Subjects with clinically significant sleep apnea who require the use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
boolean
C0037315 (UMLS CUI [1])
Pulmonary Rehabilitation
Item
Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
boolean
C0199529 (UMLS CUI [1])
Non-compliance
Item
Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
boolean
C0457432 (UMLS CUI [1])
Informed Consent, Validity, Equivocal
Item
Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1,1])
C2349101 (UMLS CUI [1,2])
C0332241 (UMLS CUI [1,3])
Experimental drug, Previous; Investigational New Drugs, Previous
Item
Prior use of study medication/other investigational drugs: Subjects who have previously been randomized in the Phase IIa (HZC111348) study or Phase III (i.e. HZC112206, HZC112207, HZC102871, HZC110946) studies. Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer
boolean
C0304229 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Clinical Investigators, Site, Affiliate
Item
Affiliation with investigator site: Study investigators, sub- investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study
boolean
C0008961 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
C1510825 (UMLS CUI [1,3])
Item Group
Exacerbation History
C0740304 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
COPD exacerbation, Medical History, Antibiotics and corticosteroids, No
Item
Number of exacerbations in the last 12 months that were managed without oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
integer
C0740304 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3653724 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
COPD exacerbation, Medical History, Antibiotics and corticosteroids
Item
Number of exacerbations in the last 12 months that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
integer
C0740304 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3653724 (UMLS CUI [1,3])
COPD exacerbation, Medical History, Hospitalization
Item
Number of exacerbations in the last 12 months that required hospitalisation
integer
C0740304 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
Item
COPD Type
text
C0024117 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Chronic Obstructive Airway Disease, Type
Code List
COPD Type
CL Item
Chronic bronchitis (1)
CL Item
Emphysema (2)
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Is this casebook ready to sign?
boolean
C2346576 (UMLS CUI [1])
Item Group
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
Laboratory Procedures, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Laboratory Procedures, Sampling, Not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Item
Coronary Artery Disease
text
C1956346 (UMLS CUI [1])
Coronary Artery Disease
Code List
Coronary Artery Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Myocardial Infarction
text
C0027051 (UMLS CUI [1])
Coronary Artery Disease
Code List
Myocardial Infarction
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Arrhythmia
text
C0003811 (UMLS CUI [1])
Coronary Artery Disease
Code List
Arrhythmia
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Congestive Heart Failure
text
C0018802 (UMLS CUI [1])
Coronary Artery Disease
Code List
Congestive Heart Failure
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Cushing's Syndrome
text
C0010481 (UMLS CUI [1])
Coronary Artery Disease
Code List
Cushing's Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Adrenal Suppression
text
C0001625 (UMLS CUI [1,1])
C1260953 (UMLS CUI [1,2])
Coronary Artery Disease
Code List
Adrenal Suppression
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Cataract
text
C0086543 (UMLS CUI [1])
Coronary Artery Disease
Code List
Cataract
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Glaucoma
text
C0017601 (UMLS CUI [1])
Coronary Artery Disease
Code List
Glaucoma
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Hypertension
text
C0020538 (UMLS CUI [1])
Coronary Artery Disease
Code List
Hypertension
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Cerebrovascular accident
text
C0038454 (UMLS CUI [1])
Coronary Artery Disease
Code List
Cerebrovascular accident
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Hypercholesterolemia
text
C0020443 (UMLS CUI [1])
Coronary Artery Disease
Code List
Hypercholesterolemia
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Diabetes Mellitus
text
C0011849 (UMLS CUI [1])
Coronary Artery Disease
Code List
Diabetes Mellitus
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Osteoporosis
text
C0029456 (UMLS CUI [1])
Coronary Artery Disease
Code List
Osteoporosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item
Pneumonia
text
C0032285 (UMLS CUI [1])
Coronary Artery Disease
Code List
Pneumonia
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item Group
Chest X-Ray
C0039985 (UMLS CUI-1)
Plain chest X-ray, Date in time
Item
Date of x-ray
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Was an infiltrate present?
text
C2073654 (UMLS CUI [1])
x-ray of chest: pulmonary infiltrate
Code List
Was an infiltrate present?
CL Item
No  (1)
CL Item
Unknown (2)
CL Item
Yes (3)
Item
Infiltrate unilateral or bilateral
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
C0205092 (UMLS CUI [1,4])
x-ray of chest: pulmonary infiltrate
Code List
Infiltrate unilateral or bilateral
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item
Characterization of infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
x-ray of chest: pulmonary infiltrate
Code List
Characterization of infiltrate
CL Item
Reticular (patchy)  (1)
CL Item
Reticulonodular (2)
CL Item
Acinar (consolidated) (3)
CL Item
Acinar with Air Bronchograms  (4)
CL Item
Not applicable (5)
Item
Right upper lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261074 (UMLS CUI [1,3])
x-ray of chest: pulmonary infiltrate
Code List
Right upper lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Right middle lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0225757 (UMLS CUI [1,3])
x-ray of chest: pulmonary infiltrate
Code List
Right middle lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Right lower lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261075 (UMLS CUI [1,3])
x-ray of chest: pulmonary infiltrate
Code List
Right lower lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Left upper lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261076 (UMLS CUI [1,3])
x-ray of chest: pulmonary infiltrate
Code List
Left upper lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Lingula involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0225740 (UMLS CUI [1,3])
x-ray of chest: pulmonary infiltrate
Code List
Lingula involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Left lower lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261077 (UMLS CUI [1,3])
x-ray of chest: pulmonary infiltrate
Code List
Left lower lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Was a pleural effusion identified?
text
C0039985 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
x-ray of chest: pulmonary infiltrate
Code List
Was a pleural effusion identified?
CL Item
Absent  (1)
CL Item
Unknown (2)
CL Item
Present (3)
Item
Present, specify Location
text
C0039985 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
x-ray of chest: pulmonary infiltrate
Code List
Present, specify Location
CL Item
Right chest (1)
CL Item
Left chest  (2)
CL Item
Bilateral (3)
Item
Lung findings atelectasis
text
C0039985 (UMLS CUI [1,1])
C0004144 (UMLS CUI [1,2])
x-ray of chest: pulmonary infiltrate
Code List
Lung findings atelectasis
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Lung findings mass?
text
C0039985 (UMLS CUI [1,1])
C0149726 (UMLS CUI [1,2])
x-ray of chest: pulmonary infiltrate
Code List
Lung findings mass?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Lung findings cardiomegaly?
text
C0039985 (UMLS CUI [1,1])
C0018800 (UMLS CUI [1,2])
x-ray of chest: pulmonary infiltrate
Code List
Lung findings cardiomegaly?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Was pulmonary edema identified?
text
C0039985 (UMLS CUI [1,1])
C0034063 (UMLS CUI [1,2])
Plain chest X-ray, Pulmonary Edema
Code List
Was pulmonary edema identified?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Plain chest X-ray, Comment
Item
Comment
text
C0039985 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Previous Clinical Trial Participation
C2348568 (UMLS CUI-1)
Item
Did the subject participate in a previous Fluticasone Furoate/GW642444 clinical trial?
text
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Study Subject Participation Status, Investigational New Drugs
Code List
Did the subject participate in a previous Fluticasone Furoate/GW642444 clinical trial?
CL Item
No (1)
CL Item
Yes, complete the following: B2C111045 - Subject # HZC111348 - Subject # (2)
Item Group
Rescreening of Subject
C0220908 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Screening Procedure, Repeat
Item
Was the subject rescreened?
boolean
C0220908 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item Group
Subject Status at Screening
C0220908 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Screening procedure, Trial Screen Failure
Item
Was the subject a screen failure at the Screening visit?
boolean
C0220908 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
History of Tobacco Use
C0841002 (UMLS CUI-1)
Item
What is the subject's history of smoking use?
text
C0841002 (UMLS CUI [1])
History of tobacco use
Code List
What is the subject's history of smoking use?
CL Item
Current smoker (1)
CL Item
Former smoker (2)
Tobacco use, Last, Date in time
Item
Former smoker, when did the subject last smoke?
date
C0543414 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
number of cigarettes per day
Item
Average number of cigarettes smoked per day?
integer
C3694146 (UMLS CUI [1])
Smoking, year, Count of entities
Item
Number of years during which the subject has smoked tobacco?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Pack years
Item
Number of pack years?
integer
C1277691 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
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