ID

19102

Beschreibung

Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00152984

Link

https://clinicaltrials.gov/show/NCT00152984

Stichworte

Versionen (1)
  1. 05.12.16 05.12.16 -
Hochgeladen am

5. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Pulmonary Disease, Chronic Obstructive NCT00152984

Englisch

Eligibility Pulmonary Disease, Chronic Obstructive NCT00152984

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of copd and diagnosis of asthma before the age of 30
Beschreibung

Chronic Obstructive Airway Disease | Asthma | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0001779
current or ex-smokers with a cigarette smoking history of at least 10 pack-years
Beschreibung

Tobacco use | smoking cigarettes: ____ pack-years history

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C2230126
treatment with inhaled steroids at least 1 year before study entry
Beschreibung

inhaled steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C2065041
fev1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
Beschreibung

FEV 1 increased | Albuterol | Salbutamol reversibility

Datentyp

boolean

Alias
UMLS CUI [1]
C0860909
UMLS CUI [2]
C0001927
UMLS CUI [3]
C1271924
fev1 increase of more than 200 ml 30 min. after 400 mcg salbutamol or documented increase of 200 ml after reversibility test within the last 5 years
Beschreibung

FEV 1 increased | Albuterol | Salbutamol reversibility

Datentyp

boolean

Alias
UMLS CUI [1]
C0860909
UMLS CUI [2]
C0001927
UMLS CUI [3]
C1271924
post bronchodilator fev1 less than 80% predicted normal (eccs) at visit 1
Beschreibung

post bronchodilator FEV1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C0748133
post bronchodilator fev1 less than 70% of fvc at visit 1
Beschreibung

post bronchodilator FEV1 | Forced vital capacity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C0748133
UMLS CUI [2]
C1287681
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
respiratory infection or exacerbation 6 weeks prior to visit 1 or during run-in period.
Beschreibung

Respiratory Tract Infection | Respiratory Tract Infection Exacerbation

Datentyp

boolean

Alias
UMLS CUI [1]
C0035243
UMLS CUI [2,1]
C0035243
UMLS CUI [2,2]
C0235874
significant diseases other than copd or asthma
Beschreibung

Disease Significant | Chronic Obstructive Airway Disease | Asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0004096
myocardial infarction within the last 6 months
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
Beschreibung

Cardiac Arrhythmia Unstable Requirement Surgical and medical procedures | Cardiac Arrhythmia Life Threatening Requirement Surgical and medical procedures | Cardiac Arrhythmia Unstable Requirement Therapy change | Cardiac Arrhythmia Life Threatening Requirement Therapy change

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C1948041
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C1948041
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C1514873
UMLS CUI [3,4]
C3665894
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C2826244
UMLS CUI [4,3]
C1514873
UMLS CUI [4,4]
C3665894
hospitalisation for heart failure (nyha class iii or iv) within the last year
Beschreibung

Hospitalization Due to Heart Failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C1275491
history of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Beschreibung

Airway Obstruction Life Threatening | Cystic Fibrosis | Bronchiectasis Evidence Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001883
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0010674
UMLS CUI [3,1]
C0006267
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0205210
known active tuberculosis
Beschreibung

Tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0041296
history of thoracotomy with pulmonary resection
Beschreibung

Thoracotomy | Lung excision

Datentyp

boolean

Alias
UMLS CUI [1]
C0039991
UMLS CUI [2]
C0396565
history of cancer within the last 5 years (excluding treated basal cell carcinoma)
Beschreibung

Malignant Neoplasms | Basal cell carcinoma Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
patients requiring oxygen therapy for more than 1 hour per day
Beschreibung

Oxygen Therapy Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184633
UMLS CUI [1,2]
C0686904
patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before visit 1
Beschreibung

Pulmonary rehabilitation program commenced | Pulmonary rehabilitation program completed

Datentyp

boolean

Alias
UMLS CUI [1]
C1272302
UMLS CUI [2]
C1272303
known hypersensitivity to anticholinergic drugs or lactose
Beschreibung

Anticholinergic allergy | Hypersensitivity Lactose

Datentyp

boolean

Alias
UMLS CUI [1]
C0570982
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022949
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Ähnliche Modelle

Eligibility Pulmonary Disease, Chronic Obstructive NCT00152984

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Obstructive Airway Disease | Asthma | Age
Item
diagnosis of copd and diagnosis of asthma before the age of 30
boolean
C0024117 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Tobacco use | smoking cigarettes: ____ pack-years history
Item
current or ex-smokers with a cigarette smoking history of at least 10 pack-years
boolean
C0543414 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
inhaled steroids
Item
treatment with inhaled steroids at least 1 year before study entry
boolean
C2065041 (UMLS CUI [1])
FEV 1 increased | Albuterol | Salbutamol reversibility
Item
fev1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
boolean
C0860909 (UMLS CUI [1])
C0001927 (UMLS CUI [2])
C1271924 (UMLS CUI [3])
FEV 1 increased | Albuterol | Salbutamol reversibility
Item
fev1 increase of more than 200 ml 30 min. after 400 mcg salbutamol or documented increase of 200 ml after reversibility test within the last 5 years
boolean
C0860909 (UMLS CUI [1])
C0001927 (UMLS CUI [2])
C1271924 (UMLS CUI [3])
post bronchodilator FEV1
Item
post bronchodilator fev1 less than 80% predicted normal (eccs) at visit 1
boolean
C2599594 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
post bronchodilator FEV1 | Forced vital capacity
Item
post bronchodilator fev1 less than 70% of fvc at visit 1
boolean
C2599594 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
C1287681 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Respiratory Tract Infection | Respiratory Tract Infection Exacerbation
Item
respiratory infection or exacerbation 6 weeks prior to visit 1 or during run-in period.
boolean
C0035243 (UMLS CUI [1])
C0035243 (UMLS CUI [2,1])
C0235874 (UMLS CUI [2,2])
Disease Significant | Chronic Obstructive Airway Disease | Asthma
Item
significant diseases other than copd or asthma
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
Myocardial Infarction
Item
myocardial infarction within the last 6 months
boolean
C0027051 (UMLS CUI [1])
Cardiac Arrhythmia Unstable Requirement Surgical and medical procedures | Cardiac Arrhythmia Life Threatening Requirement Surgical and medical procedures | Cardiac Arrhythmia Unstable Requirement Therapy change | Cardiac Arrhythmia Life Threatening Requirement Therapy change
Item
unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
boolean
C0003811 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1948041 (UMLS CUI [1,4])
C0003811 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1948041 (UMLS CUI [2,4])
C0003811 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C3665894 (UMLS CUI [3,4])
C0003811 (UMLS CUI [4,1])
C2826244 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
C3665894 (UMLS CUI [4,4])
Hospitalization Due to Heart Failure New York Heart Association Classification
Item
hospitalisation for heart failure (nyha class iii or iv) within the last year
boolean
C3898876 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Airway Obstruction Life Threatening | Cystic Fibrosis | Bronchiectasis Evidence Clinical
Item
history of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
boolean
C0001883 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0010674 (UMLS CUI [2])
C0006267 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0205210 (UMLS CUI [3,3])
Tuberculosis
Item
known active tuberculosis
boolean
C0041296 (UMLS CUI [1])
Thoracotomy | Lung excision
Item
history of thoracotomy with pulmonary resection
boolean
C0039991 (UMLS CUI [1])
C0396565 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated
Item
history of cancer within the last 5 years (excluding treated basal cell carcinoma)
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Oxygen Therapy Patient need for
Item
patients requiring oxygen therapy for more than 1 hour per day
boolean
C0184633 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Pulmonary rehabilitation program commenced | Pulmonary rehabilitation program completed
Item
patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before visit 1
boolean
C1272302 (UMLS CUI [1])
C1272303 (UMLS CUI [2])
Anticholinergic allergy | Hypersensitivity Lactose
Item
known hypersensitivity to anticholinergic drugs or lactose
boolean
C0570982 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0022949 (UMLS CUI [2,2])
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