ID

43226

Description

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

Link

http://clinicaltrials.gov/show/NCT00274573

Keywords

Versions (4)
  1. 2/28/12 2/28/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 8/11/14 8/11/14 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00274573 Pulmonary Disease, Chronic Obstructive

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Male or female patients 40 years of age or older
Description

Age 40 years or older

Data type

boolean

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.
Description

COPD

Data type

boolean

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)
Description

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)

Data type

boolean

Alias
UMLS CUI-1
C1519386
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
Description

Study related tests

Data type

boolean

Patients must be able to inhale medication from the HandiHaler
Description

inhale medication

Data type

boolean

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
Description

consent

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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.
Description

significant diseases

Data type

boolean

Patients with a recent history (i.e., one year or less) of myocardial infarction.
Description

Myocardial Infarction

Data type

boolean

Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
Description

Cardiac Arrhythmia

Data type

boolean

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.
Description

daytime oxygen

Data type

boolean

Patients with known active tuberculosis.
Description

tuberculosis

Data type

boolean

Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
Description

Cancer

Data type

boolean

Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
Description

major pulmonary Diseases

Data type

boolean

Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1.
Description

Thoracotomy

Data type

boolean

Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
Description

Respiratory Infections

Data type

boolean

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).
Description

pulmonary rehabilitation program

Data type

boolean

Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
Description

Allergies

Data type

boolean

Patients with known symptomatic prostate hypertrophy or bladder neck obstruction.
Description

prostate hypertrophy or bladder neck obstruction

Data type

boolean

Patients with known narrow-angle glaucoma.
Description

narrow-angle glaucoma

Data type

boolean

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.
Description

oral corticosteroids

Data type

boolean

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).
Description

pregnant

Data type

boolean

Patients with a history of asthma, allergic rhinitis or atopy.
Description

history of asthma, allergic rhinitis or atopy.

Data type

boolean

Patients with a history of and/or active significant alcohol or drug abuse.
Description

alcohol or drug abuse

Data type

boolean

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.
Description

other trial

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
disorder
Description

Disease

Data type

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
Chronic Obstructive Pulmonary Disease
Description

COPD

Data type

string

Alias
UMLS CUI
C0024117
SNOMED CT 2010_0731
13645005
MedDRA 13.1
10009033
ICD-10-CM Version 2010
J44.9
ICD-9-CM Version 2011
496
Spirometry
Description

Spirometry

Data type

string

Alias
UMLS CUI
C0037981
SNOMED CT 2010_0731
127783003
MedDRA 13.1
10041629
Respiratory obstruction
Description

Airway Obstruction

Data type

string

Alias
UMLS CUI
C0001883
SNOMED CT 2010_0731
79688008
MedDRA 13.1
10001539
Forced expired volume in one second/vital capacity ratio
Description

FEV1/VC

Data type

string

Alias
UMLS CUI
C0429744
SNOMED CT 2010_0731
251943006
European Coal and Steel Community
Description

ECCS

Data type

string

Alias
UMLS CUI
C0524592
Pack years (assessment scale)
Description

Pack Year

Data type

string

Alias
UMLS CUI
C1277691
SNOMED CT 2010_0731
315609007
Test
Description

Test

Data type

string

Alias
UMLS CUI
C0392366
SNOMED CT 2010_0731
C47891
Lung function tests
Description

Pulmonary function tests

Data type

string

Alias
UMLS CUI
C0024119
SNOMED CT 2010_0731
23426006
MedDRA 13.1
10025099
LOINC Version 232
MTHU029811
Peak expiratory flow rate measurement
Description

PEFR

Data type

string

Alias
UMLS CUI
C0030735
MedDRA 13.1
10034192
Peak expiratory flow rate monitoring using diary
Description

PEFR monitoring using diary

Data type

string

Alias
UMLS CUI
C1276011
SNOMED CT 2010_0731
401011001
Home Medications
Description

Home Medications

Data type

string

Alias
UMLS CUI
C0013227
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Subject Participation Status in Clinical Study
Description

Study Subject Participation Status

Data type

string

Alias
UMLS CUI
C2348568
disease risk
Description

disorder risk

Data type

string

Alias
UMLS CUI
C1281905
Heart infarction
Description

Myocardial Infarction (MI)

Data type

string

Alias
UMLS CUI
C0027051
SNOMED CT 2010_0731
22298006
MedDRA 13.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE Version 4.03
E10152
Cardiac Arrhythmia
Description

Cardiac Arrhythmia

Data type

string

Alias
UMLS CUI
C0003811
SNOMED CT 2010_0731
44808001
MedDRA 13.1
10003119
ICD-9-CM Version 2011
427.9
Drug Therapy
Description

Drug Therapy

Data type

string

Alias
UMLS CUI
CL428482
Heart failure
Description

Heart failure

Data type

string

Alias
UMLS CUI
C0018801
SNOMED CT 2010_0731
155374007
MedDRA 13.1
10019279
ICD-9-CM Version 2011
428
CTCAE Version 4.03
E10124
Warburg Therapy
Description

Oxygen Therapy

Data type

string

Alias
UMLS CUI
CL426373
Active tuberculosis
Description

Active tuberculosis

Data type

string

Alias
UMLS CUI
C0151332
SNOMED CT 2010_0731
427099000
MedDRA 13.1
10071157
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Basal cell carcinoma
Description

Basal cell carcinoma

Data type

string

Alias
UMLS CUI
C0007117
SNOMED CT 2010_0731
1338007
MedDRA 13.1
10004146
Lung structure
Description

Lung

Data type

string

Alias
UMLS CUI
C0024109
SNOMED CT 2010_0731
39607008
LOINC Version 232
MTHU008683
Obstruction
Description

Obstruction

Data type

string

Alias
UMLS CUI
C0028778
SNOMED CT 2010_0731
26036001
MedDRA 13.1
10061876
Mucoviscidosis
Description

Cystic Fibrosis (CF)

Data type

string

Alias
UMLS CUI
C0010674
SNOMED CT 2010_0731
190905008
MedDRA 13.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
Bronchiectasis
Description

Bronchiectasis

Data type

string

Alias
UMLS CUI
C0006267
SNOMED CT 2010_0731
12295008
MedDRA 13.1
10006445
ICD-10-CM Version 2010
J47.9
ICD-9-CM Version 2011
494
Opening of chest
Description

Thoracotomy

Data type

string

Alias
UMLS CUI
C0039991
SNOMED CT 2010_0731
177765008
MedDRA 13.1
10043491
ICD-9-CM Version 2011
34.01
Pulmonary resection
Description

Lung excision

Data type

string

Alias
UMLS CUI
C0396565
SNOMED CT 2010_0731
119746007
Respiratory Tract Infections
Description

Respiratory Infections

Data type

string

Alias
UMLS CUI
C0035243
SNOMED CT 2010_0731
275498002
MedDRA 13.1
10062352
LOINC Version 232
MTHU026191
Screening
Description

Screening

Data type

string

Alias
UMLS CUI
C1409616
Pulmonary rehabilitation programme completed
Description

Pulmonary rehabilitation program completed

Data type

string

Alias
UMLS CUI
C1272303
SNOMED CT 2010_0731
391130000
Anticholinergic allergy
Description

Anticholinergic allergy

Data type

string

Alias
UMLS CUI
C0570982
SNOMED CT 2010_0731
294065003
Lactose malabsorption
Description

Lactose Intolerance

Data type

string

Alias
UMLS CUI
C0022951
SNOMED CT 2010_0731
267425008
MedDRA 13.1
10023681
ICD-10-CM Version 2010
E73.9
Inhaled drug administration
Description

Inhalation Drug Administration

Data type

string

Alias
UMLS CUI
C0001559
SNOMED CT 2010_0731
243132000
adenofibromatous hypertrophy of prostate
Description

Prostatic Hypertrophy

Data type

string

Alias
UMLS CUI
C1739363
MedDRA 13.1
10036962
ICD-10-CM Version 2010
N40
Bladder neck obstruction
Description

Bladder obstruction

Data type

string

Alias
UMLS CUI
C0005694
SNOMED CT 2010_0731
399072004
MedDRA 13.1
10005060
ICD-10-CM Version 2010
N32.0
ICD-9-CM Version 2011
596.0
Chronic narrow angle glaucoma
Description

Anatomical narrow angle glaucoma

Data type

string

Alias
UMLS CUI
C0154947
SNOMED CT 2010_0731
33647009
MedDRA 13.1
10008833
ICD-10-CM Version 2010
H40.22
ICD-9-CM Version 2011
365.23
Therapeutic Corticosteroid
Description

Corticosteroids

Data type

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
prednisolone (substance)
Description

prednisolone

Data type

string

Alias
UMLS CUI
C0032950
SNOMED CT 2010_0731
116601002
LOINC Version 232
MTHU003522
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception, Birth control
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Oral contraceptive preparation
Description

Contraceptives, Oral

Data type

string

Alias
UMLS CUI
C0009905
SNOMED CT 2010_0731
59261009
Intrauterine contraceptive device
Description

Intrauterine Devices

Data type

string

Alias
UMLS CUI
C0021900
SNOMED CT 2010_0731
268460000
MedDRA 13.1
10022745
Subdermal implantation of progesterone
Description

Subdermal implantation of progesterone

Data type

string

Alias
UMLS CUI
C0864560
Implant, device
Description

Implant

Data type

string

Alias
UMLS CUI
C0021102
SNOMED CT 2010_0731
40388003
Subcutaneous route
Description

subdermal

Data type

string

Alias
UMLS CUI
C1522438
SNOMED CT 2010_0731
34206005
HL7 V3 02-34
SubcutaneousRoute
Vaginal contraceptive diaphragm (device)
Description

Contraceptive diaphragm

Data type

string

Alias
UMLS CUI
C0042241
SNOMED CT 2010_0731
20359006
Asthma
Description

Bronchial Asthma

Data type

string

Alias
UMLS CUI
C0004096
SNOMED CT 2010_0731
195967001
MedDRA 13.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
Allergic rhinitis due to allergen
Description

Allergic rhinitis

Data type

string

Alias
UMLS CUI
C2607914
SNOMED CT 2010_0731
61582004
MedDRA 13.1
10039085
ICD-10-CM Version 2010
J30.9
ICD-9-CM Version 2011
477.9
CTCAE Version 4.03
E13303
Atopic Allergy
Description

Atopy

Data type

string

Alias
UMLS CUI
C0392707
SNOMED CT 2010_0731
115665000
MedDRA 13.1
10003645
Alcohol abuse
Description

Alcohol abuse

Data type

string

Alias
UMLS CUI
C0085762
SNOMED CT 2010_0731
15167005
MedDRA 13.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
Drug abuse
Description

Drug abuse

Data type

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Investigational New Drug
Description

Investigational Drug

Data type

string

Alias
UMLS CUI
C0013230
Screening
Description

Screening

Data type

string

Alias
UMLS CUI
C1409616
patient encounter
Description

visit

Data type

string

Alias
UMLS CUI
C1512346
HL7 V3 02-34
ENC
Random Allocation
Description

Randomization

Data type

string

Alias
UMLS CUI
C0034656
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age 40 years or older
Item
Male or female patients 40 years of age or older
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
Item Group
Exclusion Criteria
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
Item Group
Medical Concepts
Age
Item
Age
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Disease
Item
disorder
string
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
COPD
Item
Chronic Obstructive Pulmonary Disease
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
Spirometry
string
C0037981 (UMLS CUI)
127783003 (SNOMED CT 2010_0731)
10041629 (MedDRA 13.1)
Airway Obstruction
Item
Respiratory obstruction
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
Lung function tests
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
Informed Consent
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
Heart infarction
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
Cardiac Arrhythmia
string
C0003811 (UMLS CUI)
44808001 (SNOMED CT 2010_0731)
10003119 (MedDRA 13.1)
427.9 (ICD-9-CM Version 2011)
Drug Therapy
Item
Drug Therapy
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
Warburg Therapy
string
CL426373 (UMLS CUI)
Active tuberculosis
Item
Active tuberculosis
string
C0151332 (UMLS CUI)
427099000 (SNOMED CT 2010_0731)
10071157 (MedDRA 13.1)
Cancer
Item
Malignant Neoplasms
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
Basal cell carcinoma
string
C0007117 (UMLS CUI)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)
Lung
Item
Lung structure
string
C0024109 (UMLS CUI)
39607008 (SNOMED CT 2010_0731)
MTHU008683 (LOINC Version 232)
Obstruction
Item
Obstruction
string
C0028778 (UMLS CUI)
26036001 (SNOMED CT 2010_0731)
10061876 (MedDRA 13.1)
Cystic Fibrosis (CF)
Item
Mucoviscidosis
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
Opening of chest
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
Respiratory Tract Infections
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
Lactose malabsorption
string
C0022951 (UMLS CUI)
267425008 (SNOMED CT 2010_0731)
10023681 (MedDRA 13.1)
E73.9 (ICD-10-CM Version 2010)
Inhalation Drug Administration
Item
Inhaled drug administration
string
C0001559 (UMLS CUI)
243132000 (SNOMED CT 2010_0731)
Prostatic Hypertrophy
Item
adenofibromatous hypertrophy of prostate
string
C1739363 (UMLS CUI)
10036962 (MedDRA 13.1)
N40 (ICD-10-CM Version 2010)
Bladder obstruction
Item
Bladder neck obstruction
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
Chronic narrow angle glaucoma
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
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
prednisolone
Item
prednisolone (substance)
string
C0032950 (UMLS CUI)
116601002 (SNOMED CT 2010_0731)
MTHU003522 (LOINC Version 232)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception, Birth control
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Contraceptives, Oral
Item
Oral contraceptive preparation
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
Subcutaneous route
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
Allergic rhinitis due to allergen
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
Atopic Allergy
string
C0392707 (UMLS CUI)
115665000 (SNOMED CT 2010_0731)
10003645 (MedDRA 13.1)
Alcohol abuse
Item
Alcohol abuse
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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