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Fehler:
ID
29523
Beschreibung
Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: 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: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Screening
Stichworte
Versionen (2)
- 04.03.18 04.03.18 -
- 05.04.18 05.04.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. April 2018
DOI
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Creative Commons BY-NC 3.0
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GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463
Ähnliche Modelle
Screening
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
Item
If female, record child-bearing potential
integer
C1960468 (UMLS CUI [1])
CL Item
Post-menopausal (1)
CL Item
Sterile ( of child-bearing age) (2)
CL Item
Potentially able to bear children (3)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (3)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,2])
CL Item
IAfrican 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)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
CL Item
Type of Subject: outpatient (1)
CL Item
Informed consent: Subjects must give their signed and dated written informed consent to participate. (2)
CL Item
Gender: Male or female subjects. 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 postmenopausal 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 l 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 stradiol <40pg/ml (< l40pmol/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 su~ject entry into the study, and this male partner is the sole partner for that subject; or Implants of levonorgestral inserted for at least I month prior to the study medication administration but not beyond the third successive year following insertion; or Injectable progestogen administered for at least I 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; Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spennicidal agent (foam/gel/film/cream/suppository); or An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest (3)
CL Item
Age: >=40 years of age at Screening (Visit 1) (4)
CL Item
COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society (5)
CL Item
Tobacco use: Subjects with a current or prior history of >= l O 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 I. Number of pack years is (number of cigarettes per day /20) x number of years smoked (6)
CL Item
Severity of Disease: Subject with a measured post-albuterol/salbutamol FEY 1/FVC ratio of <=0.70 at Screening (Visit l) Subjects with a measured post-albuterol/salbutamol FEY 1 <=70% of predicted normal values calculated using NHANES [][ reference equations [Hankinson, 1999) at Screening (Visit l) Post-bronchodilator spirometry will be performed approximately l 0- l 5 minutes after the subject has selfadministered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The FEY 1/FVC ratio and FEY I percent predicted values will be calculated. (7)
CL 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 l 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 volwne, or sputum purulence (color). Subject verbal reports are llil1 acceptable. (8)
CL 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). (7)
CL Item
A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit l and at least 30 days following the last dose of oral corticosteroids (if applicable). (8)
CL Item
Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 (9)
CL 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. (10)
CL Item
Peptic Ulcer disease: Su~jects with clinically significant peptic ulcer disease that is uncontrolled. (11)
CL Item
Hypertension: Subjects with clinically significant hypertension that is uncontrolled (12)
CL 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. (13)
CL Item
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. betaagonists, corticosteroid) or components of the inhalation powder ( .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. (14)
CL Item
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years (15)
CL 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. (16)
CL Item
Additional medication: Use of the following medications within the following time intervals prior to Visit l or during the study (17)
CL Item
Oxygen therapy: Subjects receiving treatment with longterm 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. (18)
CL 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 (NIPPY) device. (19)
CL 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. (20)
CL 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. (21)
CL Item
Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. (1)
CL 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) (2)
CL Item
al-antitrypsin deficiency: Subjects with a-1 antitrypsin deficiency as the underlying cause of COPD (3)
CL Item
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases (4)
CL Item
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (5)
CL 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 xray at Screening Visit 1 (or historical radiograph obtained within 2 weeks prior to screening) that will be over-read by a central vendor. (6)
CL 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 (22)
CL Item
Prior use of study medication/other iuvestigational drugs: Subjects who have previously been randomized in the Phase lla (HZC 111348) study or Phase Ill (i.e. HZCJ 12206, HZCl 12207, HZC\02970, HZCI 10946) 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 (23)
CL Item
Affiliation with investigator site: Study investigators, subinvestigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. (24)
Subject Status
Item
Was the subject a screen failure at the Screening visit?
boolean
C2348568 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C1710476 (UMLS CUI [1,2])
Screen failure date
Item
Screen failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
screen failure reason
integer
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Did not meet inclusion/exclusion critria (1)
CL Item
Adverse Event (unspecified) (2)
CL Item
Investigator discretion, specify (3)
CL Item
Withdrew consent, specify (4)
Investigator discretion
Item
Investigator discretion, specify
text
C1710476 (UMLS CUI [1])
Withdrew consent
Item
Withdrew consent, specify
text
C1707492 (UMLS CUI [1])
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Item Group
Previous clinical trial participation
C2348568 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
participate in a previous Fluticasone Furoate/GW642444 clinical trial
Item
Did the subject participate in a previous Fluticasone Furoate/GW642444 clinical trial?
boolean
C2348568 (UMLS CUI [1,1])
C1948374 (UMLS CUI [1,2])
C1948374 (UMLS CUI [1,2])
Subject Number
Item
If Yes, Subject Number B2Cll 1045
text
C2348585 (UMLS CUI [1])
Subject Number
Item
If Yes, Subject Number HZCl l 1348
text
C2348585 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood 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])
Duration of COPD
Item
Duration of COPD
text
C0024117 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Number of exacerbations without oral/systemic corticosteroids and/or antibiotics
Item
Number of exacerbations in the last J 2 months that were managed without oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
integer
C0740304 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0449788 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
Number of exacerbations that required oral/systemic corticosteroids and/or antibiotics
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])
C0449788 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0449788 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
Number of exacerbations that required hospitalisation
Item
Number of exacerbations in the last 12 months that required hospitalisation
integer
C0740304 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2])
C0449788 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2])
CL Item
Chronic bronchitis (1)
CL Item
Emphysema (2)
Item
What is the subject's history of smoking use?
integer
C1519384 (UMLS CUI [1,1])
C0543414 (UMLS CUI [1,2])
C0543414 (UMLS CUI [1,2])
CL Item
Current smoker (1)
CL Item
Former smoker (2)
when did the subject last smoke
Item
Former smoker, when did the subject last smoke?
date
C0543414 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Average number of cigarettes smoked per day
Item
Average number of cigarettes smoked per day?
integer
C3694146 (UMLS CUI [1])
Number of years during which the subject has smoked tobacco
Item
Number of years during which the subject has smoked tobacco?
integer
C0543414 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of pack years
Item
Number of pack years?
integer
C1277691 (UMLS CUI [1])
Item Group
Oropharyngeal candidiasis examination
C0006849 (UMLS CUI-1)
C0582103 (UMLS CUI-2)
C0582103 (UMLS CUI-2)
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
text
C0006849 (UMLS CUI [1])
Code List
Does the subject have clinical evidence of oropharyngeal candidiasis?
culture swab taken
Item
Was a culture swab taken?
boolean
C0563454 (UMLS CUI [1,1])
C0006849 (UMLS CUI [1,2])
C0006849 (UMLS CUI [1,2])
Item
Yes, result of culture swab
integer
C0563454 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0006849 (UMLS CUI [2])
C1274040 (UMLS CUI [1,2])
C0006849 (UMLS CUI [2])
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (3)
Date of x-ray
Item
Date of x-ray
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Infiltrate unilateral or bilateral
integer
C0235896 (UMLS CUI [1])
C0238767 (UMLS CUI [2])
C0205092 (UMLS CUI [3])
C0238767 (UMLS CUI [2])
C0205092 (UMLS CUI [3])
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item
Characterization of infiltrate
integer
C0235896 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
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
integer
C1261074 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0235896 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Right middle lobe involved with infiltrate
integer
C4281590 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0235896 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Right lower lobe involved with infiltrate
integer
C1261075 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0235896 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Left upper lobe involved with infiltrate
integer
C1261076 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0235896 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Lingula involved with infiltrate
integer
C0225740 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0235896 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Left lower lobe involved with infiltrate
integer
C1261077 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0235896 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
CL Item
Absent (1)
CL Item
Unknown (2)
CL Item
Present, specify Location (3)
Item
Pleural effusion Present, specify Location
integer
C1253943 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
CL Item
Right chest (1)
CL Item
Left chest (2)
CL Item
Bilateral (3)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Comment Chest X-Ray
Item
Comment Chest X-Ray
text
C0039985 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item Group
Electronically transferred lab data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
sample taken
Item
Sample taken?
boolean
C0200345 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
subject rescreened
Item
Was the subject rescreened ?
boolean
C1710477 (UMLS CUI [1])