ID

43226

Beschrijving

ODM derived from http://clinicaltrials.gov/show/NCT00274573

Link

http://clinicaltrials.gov/show/NCT00274573

Trefwoorden

Klinische Studie [Dokumenttyp]

D029424

D004608

Geüploaded op

20 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

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Eligibility NCT00274573 Pulmonary Disease, Chronic Obstructive

model
Details

Eligibility

1 Formulieren

StudyEvent: Eligibility
1. Eligibility

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

Einschlusskriterien

C1512693 (UMLS CUI-1)

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

Exclusion Criteria

Item Group

Ausschlusskriterien

C0680251 (UMLS CUI-1)

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

Medical Concepts

Item Group

Medizinische Konzepte

Age

Item

Alter

integer

C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)

Disease

Item

disorder

string

C0012634 (UMLS CUI)
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)

Spirometry

Item

Spirometrie

string

C0037981 (UMLS CUI)
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)

FEV1/VC

Item

Forced expired volume in one second/vital capacity ratio

string

C0429744 (UMLS CUI)
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)

Test

Item

Test

string

C0392366 (UMLS CUI)
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)

PEFR

Item

Peak expiratory flow rate measurement

string

C0030735 (UMLS CUI)
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)

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

C1281905 (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)

Cardiac Arrhythmia

Item

Herzrhythmusstörung

string

C0003811 (UMLS CUI)
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)

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)

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)

Basal cell carcinoma

Item

Basalzellenkarzinom

string

C0007117 (UMLS CUI)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)

Lung

Item

Lunge

string

C0024109 (UMLS CUI)
39607008 (SNOMED CT 2010_0731)
MTHU008683 (LOINC Version 232)

Obstruction

Item

Obstruktion

string

C0028778 (UMLS CUI)
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)

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)

Thoracotomy

Item

Thorakotomie

string

C0039991 (UMLS CUI)
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)

Respiratory Infections

Item

Atemweginfektion

string

C0035243 (UMLS CUI)
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)

Anticholinergic allergy

Item

Anticholinergic allergy

string

C0570982 (UMLS CUI)
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)

Inhalation Drug Administration

Item

Medikamenteninhalation

string

C0001559 (UMLS CUI)
243132000 (SNOMED CT 2010_0731)

Prostatic Hypertrophy

Item

Prostatahypertrophie

string

C1739363 (UMLS CUI)
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)

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)

Corticosteroids

Item

Corticosteroide

string

C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)

prednisolone

Item

Prednisolon

string

C0032950 (UMLS CUI)
116601002 (SNOMED CT 2010_0731)
MTHU003522 (LOINC Version 232)

pregnant

Item

schwanger

string

C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)

Lactation

Item

Stillzeit

string

C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)

Contraception

Item

Kontrazeption

string

C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)

Contraceptives, Oral

Item

orales Kontrazeptivum

string

C0009905 (UMLS CUI)
59261009 (SNOMED CT 2010_0731)

Intrauterine Devices

Item

Intrauterine contraceptive device

string

C0021900 (UMLS CUI)
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)

subdermal

Item

subkutan

string

C1522438 (UMLS CUI)
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)

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)

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)

Atopy

Item

Atopie

string

C0392707 (UMLS CUI)
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)

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)

Investigational Drug

Item

Investigational New Drug

string

C0013230 (UMLS CUI)

Screening

Item

Screening

string

C1409616 (UMLS CUI)

visit

Item

patient encounter

string

C1512346 (UMLS CUI)
ENC (HL7 V3 02-34)

Randomization

Item

Random Allocation

string

C0034656 (UMLS CUI)

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Eligibility NCT00274573 Pulmonary Disease, Chronic Obstructive

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