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ID
5610
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT00274573
Link
http://clinicaltrials.gov/show/NCT00274573
Stichworte
Versionen (4)
- 28.02.12 28.02.12 -
- 13.04.14 13.04.14 - Julian Varghese
- 11.08.14 11.08.14 - Martin Dugas
- 20.09.21 20.09.21 -
Hochgeladen am
11. August 2014
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility NCT00274573 Pulmonary Disease, Chronic Obstructive
Ähnliche Modelle
Eligibility
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age 40 years or older
Item
Alter 40 Jahre oder älter
boolean
COPD
Item
All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =<70% of predicted normal and an FEV1/FVC < 70 %. Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS.
boolean
Smoking
Item
Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included)
boolean
C1519386 (UMLS CUI-1)
Study related tests
Item
Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol
boolean
inhale medication
Item
Patients must be able to inhale medication from the HandiHaler
boolean
consent
Item
All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications
boolean
significant diseases
Item
Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
boolean
Myocardial Infarction
Item
Patients with a recent history (i.e., one year or less) of myocardial infarction.
boolean
Cardiac Arrhythmia
Item
Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
boolean
daytime oxygen
Item
Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
boolean
tuberculosis
Item
Patients with known active tuberculosis.
boolean
Cancer
Item
Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
boolean
major pulmonary Diseases
Item
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
boolean
Thoracotomy
Item
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1.
boolean
Respiratory Infections
Item
Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
boolean
pulmonary rehabilitation program
Item
Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1).
boolean
Allergies
Item
Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
boolean
prostate hypertrophy or bladder neck obstruction
Item
Patients with known symptomatic prostate hypertrophy or bladder neck obstruction.
boolean
narrow-angle glaucoma
Item
Patients with known narrow-angle glaucoma.
boolean
oral corticosteroids
Item
Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
boolean
pregnant
Item
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants).
boolean
history of asthma, allergic rhinitis or atopy.
Item
Patients with a history of asthma, allergic rhinitis or atopy.
boolean
alcohol or drug abuse
Item
Patients with a history of and/or active significant alcohol or drug abuse.
boolean
other trial
Item
Patients who have taken an investigational drug within one month prior to Screening Visit (Visit 1). A log of all subjects screened, and reasons for exclusion for those not randomised will be maintained.
boolean
Age
Item
Alter
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
397669002 (SNOMED CT 2010_0731)
Disease
Item
disorder
string
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
64572001 (SNOMED CT 2010_0731)
COPD
Item
COPD
string
C0024117 (UMLS CUI)
13645005 (SNOMED CT 2010_0731)
10009033 (MedDRA 13.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
13645005 (SNOMED CT 2010_0731)
10009033 (MedDRA 13.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
Spirometry
Item
Spirometrie
string
C0037981 (UMLS CUI)
127783003 (SNOMED CT 2010_0731)
10041629 (MedDRA 13.1)
127783003 (SNOMED CT 2010_0731)
10041629 (MedDRA 13.1)
Airway Obstruction
Item
Atemwegsobstruktion
string
C0001883 (UMLS CUI)
79688008 (SNOMED CT 2010_0731)
10001539 (MedDRA 13.1)
79688008 (SNOMED CT 2010_0731)
10001539 (MedDRA 13.1)
FEV1/VC
Item
Forced expired volume in one second/vital capacity ratio
string
C0429744 (UMLS CUI)
251943006 (SNOMED CT 2010_0731)
251943006 (SNOMED CT 2010_0731)
ECCS
Item
European Coal and Steel Community
string
C0524592 (UMLS CUI)
Pack Year
Item
Pack years (assessment scale)
string
C1277691 (UMLS CUI)
315609007 (SNOMED CT 2010_0731)
315609007 (SNOMED CT 2010_0731)
Test
Item
Test
string
C0392366 (UMLS CUI)
C47891 (SNOMED CT 2010_0731)
C47891 (SNOMED CT 2010_0731)
Pulmonary function tests
Item
Lungenfunktionstest
string
C0024119 (UMLS CUI)
23426006 (SNOMED CT 2010_0731)
10025099 (MedDRA 13.1)
MTHU029811 (LOINC Version 232)
23426006 (SNOMED CT 2010_0731)
10025099 (MedDRA 13.1)
MTHU029811 (LOINC Version 232)
PEFR
Item
Peak expiratory flow rate measurement
string
C0030735 (UMLS CUI)
10034192 (MedDRA 13.1)
10034192 (MedDRA 13.1)
PEFR monitoring using diary
Item
Peak expiratory flow rate monitoring using diary
string
C1276011 (UMLS CUI)
401011001 (SNOMED CT 2010_0731)
401011001 (SNOMED CT 2010_0731)
Home Medications
Item
Home Medications
string
C0013227 (UMLS CUI)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Study Subject Participation Status
Item
Subject Participation Status in Clinical Study
string
C2348568 (UMLS CUI)
disorder risk
Item
disease risk
string
C0683481 (UMLS CUI)
Myocardial Infarction (MI)
Item
Herzinfarkt
string
C0027051 (UMLS CUI)
22298006 (SNOMED CT 2010_0731)
10028596 (MedDRA 13.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE Version 4.03)
22298006 (SNOMED CT 2010_0731)
10028596 (MedDRA 13.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE Version 4.03)
Cardiac Arrhythmia
Item
Herzrhythmusstörung
string
C0003811 (UMLS CUI)
44808001 (SNOMED CT 2010_0731)
10003119 (MedDRA 13.1)
427.9 (ICD-9-CM Version 2011)
44808001 (SNOMED CT 2010_0731)
10003119 (MedDRA 13.1)
427.9 (ICD-9-CM Version 2011)
Drug Therapy
Item
medikamentöse Therapie
string
CL428482 (UMLS CUI)
Heart failure
Item
Heart failure
string
C0018801 (UMLS CUI)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE Version 4.03)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE Version 4.03)
Oxygen Therapy
Item
Sauerstofftherapie
string
CL426373 (UMLS CUI)
Active tuberculosis
Item
Aktive Tuberkulose
string
C0151332 (UMLS CUI)
427099000 (SNOMED CT 2010_0731)
10071157 (MedDRA 13.1)
427099000 (SNOMED CT 2010_0731)
10071157 (MedDRA 13.1)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Basal cell carcinoma
Item
Basalzellenkarzinom
string
C0007117 (UMLS CUI)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)
Lung
Item
Lunge
string
Obstruction
Item
Obstruktion
string
C0028778 (UMLS CUI)
26036001 (SNOMED CT 2010_0731)
10061876 (MedDRA 13.1)
26036001 (SNOMED CT 2010_0731)
10061876 (MedDRA 13.1)
Cystic Fibrosis (CF)
Item
Mukoviszidose
string
C0010674 (UMLS CUI)
190905008 (SNOMED CT 2010_0731)
10011762 (MedDRA 13.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
190905008 (SNOMED CT 2010_0731)
10011762 (MedDRA 13.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
Bronchiectasis
Item
Bronchiectasis
string
C0006267 (UMLS CUI)
12295008 (SNOMED CT 2010_0731)
10006445 (MedDRA 13.1)
J47.9 (ICD-10-CM Version 2010)
494 (ICD-9-CM Version 2011)
12295008 (SNOMED CT 2010_0731)
10006445 (MedDRA 13.1)
J47.9 (ICD-10-CM Version 2010)
494 (ICD-9-CM Version 2011)
Thoracotomy
Item
Thorakotomie
string
C0039991 (UMLS CUI)
177765008 (SNOMED CT 2010_0731)
10043491 (MedDRA 13.1)
34.01 (ICD-9-CM Version 2011)
177765008 (SNOMED CT 2010_0731)
10043491 (MedDRA 13.1)
34.01 (ICD-9-CM Version 2011)
Lung excision
Item
Pulmonary resection
string
C0396565 (UMLS CUI)
119746007 (SNOMED CT 2010_0731)
119746007 (SNOMED CT 2010_0731)
Respiratory Infections
Item
Atemweginfektion
string
C0035243 (UMLS CUI)
275498002 (SNOMED CT 2010_0731)
10062352 (MedDRA 13.1)
MTHU026191 (LOINC Version 232)
275498002 (SNOMED CT 2010_0731)
10062352 (MedDRA 13.1)
MTHU026191 (LOINC Version 232)
Screening
Item
Screening
string
C1409616 (UMLS CUI)
Pulmonary rehabilitation program completed
Item
Pulmonary rehabilitation programme completed
string
C1272303 (UMLS CUI)
391130000 (SNOMED CT 2010_0731)
391130000 (SNOMED CT 2010_0731)
Anticholinergic allergy
Item
Anticholinergic allergy
string
C0570982 (UMLS CUI)
294065003 (SNOMED CT 2010_0731)
294065003 (SNOMED CT 2010_0731)
Lactose Intolerance
Item
Laktoseintoleranz
string
C0022951 (UMLS CUI)
267425008 (SNOMED CT 2010_0731)
10023681 (MedDRA 13.1)
E73.9 (ICD-10-CM Version 2010)
267425008 (SNOMED CT 2010_0731)
10023681 (MedDRA 13.1)
E73.9 (ICD-10-CM Version 2010)
Inhalation Drug Administration
Item
Medikamenteninhalation
string
C0001559 (UMLS CUI)
243132000 (SNOMED CT 2010_0731)
243132000 (SNOMED CT 2010_0731)
Prostatic Hypertrophy
Item
Prostatahypertrophie
string
C1739363 (UMLS CUI)
10036962 (MedDRA 13.1)
N40 (ICD-10-CM Version 2010)
10036962 (MedDRA 13.1)
N40 (ICD-10-CM Version 2010)
Bladder obstruction
Item
Blasenhalsobstruktion
string
C0005694 (UMLS CUI)
399072004 (SNOMED CT 2010_0731)
10005060 (MedDRA 13.1)
N32.0 (ICD-10-CM Version 2010)
596.0 (ICD-9-CM Version 2011)
399072004 (SNOMED CT 2010_0731)
10005060 (MedDRA 13.1)
N32.0 (ICD-10-CM Version 2010)
596.0 (ICD-9-CM Version 2011)
Anatomical narrow angle glaucoma
Item
Engwinkelglaukom
string
C0154947 (UMLS CUI)
33647009 (SNOMED CT 2010_0731)
10008833 (MedDRA 13.1)
H40.22 (ICD-10-CM Version 2010)
365.23 (ICD-9-CM Version 2011)
33647009 (SNOMED CT 2010_0731)
10008833 (MedDRA 13.1)
H40.22 (ICD-10-CM Version 2010)
365.23 (ICD-9-CM Version 2011)
Corticosteroids
Item
Corticosteroide
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
79440004 (SNOMED CT 2010_0731)
prednisolone
Item
Prednisolon
string
pregnant
Item
schwanger
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
10036586 (MedDRA 13.1)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
10006247 (MedDRA 13.1)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Contraceptives, Oral
Item
orales Kontrazeptivum
string
C0009905 (UMLS CUI)
59261009 (SNOMED CT 2010_0731)
59261009 (SNOMED CT 2010_0731)
Intrauterine Devices
Item
Intrauterine contraceptive device
string
C0021900 (UMLS CUI)
268460000 (SNOMED CT 2010_0731)
10022745 (MedDRA 13.1)
268460000 (SNOMED CT 2010_0731)
10022745 (MedDRA 13.1)
Subdermal implantation of progesterone
Item
Subdermal implantation of progesterone
string
C0864560 (UMLS CUI)
Implant
Item
Implant, device
string
C0021102 (UMLS CUI)
40388003 (SNOMED CT 2010_0731)
40388003 (SNOMED CT 2010_0731)
subdermal
Item
subkutan
string
C0205523 (UMLS CUI)
34206005 (SNOMED CT 2010_0731)
SubcutaneousRoute (HL7 V3 02-34)
34206005 (SNOMED CT 2010_0731)
SubcutaneousRoute (HL7 V3 02-34)
Contraceptive diaphragm
Item
Vaginal contraceptive diaphragm (device)
string
C0042241 (UMLS CUI)
20359006 (SNOMED CT 2010_0731)
20359006 (SNOMED CT 2010_0731)
Bronchial Asthma
Item
Asthma
string
C0004096 (UMLS CUI)
195967001 (SNOMED CT 2010_0731)
10003553 (MedDRA 13.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
195967001 (SNOMED CT 2010_0731)
10003553 (MedDRA 13.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
Allergic rhinitis
Item
Rhinitis allergica
string
C2607914 (UMLS CUI)
61582004 (SNOMED CT 2010_0731)
10039085 (MedDRA 13.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE Version 4.03)
61582004 (SNOMED CT 2010_0731)
10039085 (MedDRA 13.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE Version 4.03)
Atopy
Item
Atopie
string
C0392707 (UMLS CUI)
115665000 (SNOMED CT 2010_0731)
10003645 (MedDRA 13.1)
115665000 (SNOMED CT 2010_0731)
10003645 (MedDRA 13.1)
Alcohol abuse
Item
Alkohol-Abusus
string
C0085762 (UMLS CUI)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Investigational Drug
Item
Investigational New Drug
string
C0013230 (UMLS CUI)
Screening
Item
Screening
string
C1409616 (UMLS CUI)
visit
Item
patient encounter
string
C1554196 (UMLS CUI)
ENC (HL7 V3 02-34)
ENC (HL7 V3 02-34)
Randomization
Item
Random Allocation
string
C0034656 (UMLS CUI)