ID

14546

Description

A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01274507

Link

https://clinicaltrials.gov/show/NCT01274507

Keywords

Versions (1)
  1. 4/20/16 4/20/16 -
Uploaded on

April 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma, NCT01274507

English

Eligibility Asthma, NCT01274507

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma, NCT01274507
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: for part 1, healthy: 18 and 55 years; for part 1, asthma: 18 and 70 years; for part 2, nonsmokers: 40 and 65 years; for part 2, smokers: 40 and 65 years; for part 2, chronic obstructive pulmonary disease (copd): 40 and 65 years
Description

Age | Healthy Volunteers | Asthma | Non-smoker | Smoker | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1708335
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0337672
UMLS CUI [5]
C0337664
UMLS CUI [6]
C0024117
having mild, moderate, or severe asthma (for part 1, asthma)
Description

Mild asthma | Moderate asthma | Severe asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581124
UMLS CUI [2]
C0581125
UMLS CUI [3]
C0581126
clinically stable asthma and have been on their current asthma controller therapy for at least 6 weeks prior to screening (for part 1, asthma)
Description

Asthma Stable status | control Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0243148
UMLS CUI [2,2]
C0087111
no history of chronic respiratory disease including asthma (for part 2, nonsmokers)
Description

Chronic disease of respiratory system | Asthma | Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0264220
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0337672
be a nonsmoker for 1 year or more at initial screening visit and have 10 packs or less per year history of smoking (for all part 1 and pat 2, nonsmokers)
Description

Non-smoker | smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C2230126
be a current smoker with a current history of at least 20 pack years (for part 2, smokers)
Description

Current Smoker | smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C2230126
stable copd in the 3 months prior to screening (for part 2, copd)
Description

Chronic Obstructive Airway Disease Stable status

Data type

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0205360
treating with beta-adrenergic receptor agonist, anticholinergic bronchodilators, inhaled corticosteroid at stable doses for at least 4 weeks prior to screening (for part 2, copd)
Description

Adrenergic beta-Agonists | BRONCHODILATORS,ANTICHOLINERGIC | inhaled steroids

Data type

boolean

Alias
UMLS CUI [1]
C0001644
UMLS CUI [2]
C0354764
UMLS CUI [3]
C2065041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of sleep apnea requiring medical intervention and positive urine pregnancy screening result (for all part 1 and part 2)
Description

Sleep Apnea Syndromes | Medical Intervention regimes | Urine pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0037315
UMLS CUI [2,1]
C0205476
UMLS CUI [2,2]
C1273869
UMLS CUI [3]
C0430059
positive urine screen for nicotine; positive serology test for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen, or hepatitis c virus antibody at screening (for all part 1 and part 2)
Description

Urine screening Nicotine Positive | HIV Seropositivity HIV Antibodies | Hepatitis B Surface Antigens | Hepatitis C Antibodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0595946
UMLS CUI [1,2]
C0028040
UMLS CUI [1,3]
C1446409
UMLS CUI [2,1]
C0019699
UMLS CUI [2,2]
C0019683
UMLS CUI [3]
C0019168
UMLS CUI [4]
C0166049
allergic bronchopulmonary aspergillosis, allergic bronchopulmonary mycosis, or occupational asthma (for part 1, asthma)
Description

Aspergillosis, Allergic Bronchopulmonary | Allergic Bronchopulmonary Mycosis | Asthma, Occupational

Data type

boolean

Alias
UMLS CUI [1]
C0004031
UMLS CUI [2]
C2931854
UMLS CUI [3]
C0264423
requires long term oxygen therapy on a daily basis for chronic hypoxemia at screening visit except when used for exercise only (for part 2, copd)
Description

Long-term oxygen therapy Chronic hypoxemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0418996
UMLS CUI [1,2]
C0745188
pneumonia, copd exacerbation that required systemic steroids, upper or lower respiratory tract infection, lung cancer surgery, lung volume reduction, or a lung transplant (for part 2, copd)
Description

Pneumonia | COPD exacerbation | systemic steroids | Upper Respiratory Infections | Lower respiratory tract infection | Malignant neoplasm of lung Surgery specialty | Lung Volume Reduction | Lung Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0032285
UMLS CUI [2]
C0740304
UMLS CUI [3]
C2825233
UMLS CUI [4]
C0041912
UMLS CUI [5]
C0149725
UMLS CUI [6,1]
C0242379
UMLS CUI [6,2]
C0038894
UMLS CUI [7]
C0524689
UMLS CUI [8]
C0024128
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Similar models

Eligibility Asthma, NCT01274507

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma, NCT01274507
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Healthy Volunteers | Asthma | Non-smoker | Smoker | Chronic Obstructive Airway Disease
Item
age: for part 1, healthy: 18 and 55 years; for part 1, asthma: 18 and 70 years; for part 2, nonsmokers: 40 and 65 years; for part 2, smokers: 40 and 65 years; for part 2, chronic obstructive pulmonary disease (copd): 40 and 65 years
boolean
C0001779 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0337672 (UMLS CUI [4])
C0337664 (UMLS CUI [5])
C0024117 (UMLS CUI [6])
Mild asthma | Moderate asthma | Severe asthma
Item
having mild, moderate, or severe asthma (for part 1, asthma)
boolean
C0581124 (UMLS CUI [1])
C0581125 (UMLS CUI [2])
C0581126 (UMLS CUI [3])
Asthma Stable status | control Therapeutic procedure
Item
clinically stable asthma and have been on their current asthma controller therapy for at least 6 weeks prior to screening (for part 1, asthma)
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0243148 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Chronic disease of respiratory system | Asthma | Non-smoker
Item
no history of chronic respiratory disease including asthma (for part 2, nonsmokers)
boolean
C0264220 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0337672 (UMLS CUI [3])
Non-smoker | smoking cigarettes: ____ pack-years history
Item
be a nonsmoker for 1 year or more at initial screening visit and have 10 packs or less per year history of smoking (for all part 1 and pat 2, nonsmokers)
boolean
C0337672 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Current Smoker | smoking cigarettes: ____ pack-years history
Item
be a current smoker with a current history of at least 20 pack years (for part 2, smokers)
boolean
C3241966 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Chronic Obstructive Airway Disease Stable status
Item
stable copd in the 3 months prior to screening (for part 2, copd)
boolean
C0024117 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Adrenergic beta-Agonists | BRONCHODILATORS,ANTICHOLINERGIC | inhaled steroids
Item
treating with beta-adrenergic receptor agonist, anticholinergic bronchodilators, inhaled corticosteroid at stable doses for at least 4 weeks prior to screening (for part 2, copd)
boolean
C0001644 (UMLS CUI [1])
C0354764 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Sleep Apnea Syndromes | Medical Intervention regimes | Urine pregnancy test positive
Item
history of sleep apnea requiring medical intervention and positive urine pregnancy screening result (for all part 1 and part 2)
boolean
C0037315 (UMLS CUI [1])
C0205476 (UMLS CUI [2,1])
C1273869 (UMLS CUI [2,2])
C0430059 (UMLS CUI [3])
Urine screening Nicotine Positive | HIV Seropositivity HIV Antibodies | Hepatitis B Surface Antigens | Hepatitis C Antibodies
Item
positive urine screen for nicotine; positive serology test for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen, or hepatitis c virus antibody at screening (for all part 1 and part 2)
boolean
C0595946 (UMLS CUI [1,1])
C0028040 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0019699 (UMLS CUI [2,1])
C0019683 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3])
C0166049 (UMLS CUI [4])
Aspergillosis, Allergic Bronchopulmonary | Allergic Bronchopulmonary Mycosis | Asthma, Occupational
Item
allergic bronchopulmonary aspergillosis, allergic bronchopulmonary mycosis, or occupational asthma (for part 1, asthma)
boolean
C0004031 (UMLS CUI [1])
C2931854 (UMLS CUI [2])
C0264423 (UMLS CUI [3])
Long-term oxygen therapy Chronic hypoxemia
Item
requires long term oxygen therapy on a daily basis for chronic hypoxemia at screening visit except when used for exercise only (for part 2, copd)
boolean
C0418996 (UMLS CUI [1,1])
C0745188 (UMLS CUI [1,2])
Pneumonia | COPD exacerbation | systemic steroids | Upper Respiratory Infections | Lower respiratory tract infection | Malignant neoplasm of lung Surgery specialty | Lung Volume Reduction | Lung Transplantation
Item
pneumonia, copd exacerbation that required systemic steroids, upper or lower respiratory tract infection, lung cancer surgery, lung volume reduction, or a lung transplant (for part 2, copd)
boolean
C0032285 (UMLS CUI [1])
C0740304 (UMLS CUI [2])
C2825233 (UMLS CUI [3])
C0041912 (UMLS CUI [4])
C0149725 (UMLS CUI [5])
C0242379 (UMLS CUI [6,1])
C0038894 (UMLS CUI [6,2])
C0524689 (UMLS CUI [7])
C0024128 (UMLS CUI [8])
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