ID

19102

Descrição

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

Palavras-chave

Versões (1)
  1. 05/12/2016 05/12/2016 -
Transferido a

5 de dezembro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Pulmonary Disease, Chronic Obstructive NCT00152984

Inglês

Eligibility Pulmonary Disease, Chronic Obstructive NCT00152984

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Chronic Obstructive Airway Disease | Asthma | Age

Tipo de dados

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
Descrição

Tobacco use | smoking cigarettes: ____ pack-years history

Tipo de dados

boolean

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

inhaled steroids

Tipo de dados

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
Descrição

FEV 1 increased | Albuterol | Salbutamol reversibility

Tipo de dados

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
Descrição

FEV 1 increased | Albuterol | Salbutamol reversibility

Tipo de dados

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
Descrição

post bronchodilator FEV1

Tipo de dados

boolean

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

post bronchodilator FEV1 | Forced vital capacity

Tipo de dados

boolean

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

Exclusion Criteria

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

Respiratory Tract Infection | Respiratory Tract Infection Exacerbation

Tipo de dados

boolean

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

Disease Significant | Chronic Obstructive Airway Disease | Asthma

Tipo de dados

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
Descrição

Myocardial Infarction

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

Hospitalization Due to Heart Failure New York Heart Association Classification

Tipo de dados

boolean

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

Airway Obstruction Life Threatening | Cystic Fibrosis | Bronchiectasis Evidence Clinical

Tipo de dados

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
Descrição

Tuberculosis

Tipo de dados

boolean

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

Thoracotomy | Lung excision

Tipo de dados

boolean

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

Malignant Neoplasms | Basal cell carcinoma Treated

Tipo de dados

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
Descrição

Oxygen Therapy Patient need for

Tipo de dados

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
Descrição

Pulmonary rehabilitation program commenced | Pulmonary rehabilitation program completed

Tipo de dados

boolean

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

Anticholinergic allergy | Hypersensitivity Lactose

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0570982
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022949
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Similar models

Eligibility Pulmonary Disease, Chronic Obstructive NCT00152984

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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