ID

14351

Description

UTMB Research on Severe Asthma (UROSA) Study; ODM derived from: https://clinicaltrials.gov/show/NCT02264691

Link

https://clinicaltrials.gov/show/NCT02264691

Keywords

Versions (1)
  1. 4/11/16 4/11/16 -
Uploaded on

April 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02264691

English

Eligibility Asthma NCT02264691

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02264691
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all participants must be in good general health (with exception to asthma). • normal controls / healthy volunteers (nc) subjects with no past history of asthma or other lung disease. to determine this, subjects must have an fev1 equal to or greater than 80% of predicted value and have a normal fev1/fvc ratio.
Description

Healthy Volunteers | Asthma | Lung diseases | FEV1 | Forced vital capacity - finding

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0748133
UMLS CUI [5]
C1287681
asthma subjects eligible asthmatic participants must have a physician diagnosis of asthma for at least 1 year. participants must either have historical evidence of reversibility of fev1 of at least 12%, or demonstrate such a change during the study visits, or must have historical evidence of a pc20 for methacholine < 8mg/ml.
Description

Asthma | Reversibility FEV1 | Volume expired during 1.0 s of forced expiration^ pre dose methacholine:Vol:Pt:Respiratory system:Qn | Methacholine

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0449261
UMLS CUI [2,2]
C0748133
UMLS CUI [3]
C1714620
UMLS CUI [4]
C0600370
mild asthma with no corticosteroids (manc) will be defined as control of asthma with short acting β2-agonists or leukotrine antagonist or both, but not requiring inhaled corticosteroids.
Description

Mild asthma | Steroids | Adrenergic beta-2 Receptor Agonists | Leukotriene Antagonists | inhaled steroids

Data type

boolean

Alias
UMLS CUI [1]
C0581124
UMLS CUI [2]
C0038317
UMLS CUI [3]
C2936789
UMLS CUI [4]
C0595726
UMLS CUI [5]
C2065041
mild to moderate asthma (mma) will be defined as control of asthma with an inhaled corticosteroid (less than or equal to 250 mcg daily inhaled fluticasone equivalent) in addition to the medications listed in the manc group or long acting β2-agonists.
Description

Mild persistent asthma | Moderate persistent asthma | inhaled steroids | fluticasone | Adrenergic beta-2 Receptor Agonists

Data type

boolean

Alias
UMLS CUI [1]
C1960046
UMLS CUI [2]
C1960047
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0082607
UMLS CUI [5]
C2936789
severe asthma (sa) will be defined according to the ats criteria for refractory asthma (10)
Description

Severe asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581126
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria apply for all subjects:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
current smoker, or former smoker with >10 pack years history or having quit within the past year
Description

Current Smoker | Former smoker Smoking cigarettes: ____ pack-years history | QUIT

Data type

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C2230126
UMLS CUI [3]
C0748223
asthma exacerbation, requiring a new or increased dose of oral corticosteroids, within the past 30 days
Description

Exacerbation of asthma | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0001617
pregnant or lactating female
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant/uncontrolled medical condition (uncontrolled diabetes, coronary artery disease, uncontrolled hypertension)
Description

Disease Uncontrolled | Diabetic - poor control | Coronary Artery Disease | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0421258
UMLS CUI [3]
C1956346
UMLS CUI [4]
C1868885
diagnosis of emphysema or other significant pulmonary disease
Description

Pulmonary Emphysema | Lung diseases

Data type

boolean

Alias
UMLS CUI [1]
C0034067
UMLS CUI [2]
C0024115
if, in the opinion of the pi (wjc) the subject has co-morbid conditions that make them unsafe to undergo bronchoscopy, subjects will be given the choice to withdraw from the study or allowed to complete visits 1-3 only.
Description

Comorbidity | Bronchoscopy Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0006290
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
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Similar models

Eligibility Asthma NCT02264691

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02264691
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Asthma | Lung diseases | FEV1 | Forced vital capacity - finding
Item
all participants must be in good general health (with exception to asthma). • normal controls / healthy volunteers (nc) subjects with no past history of asthma or other lung disease. to determine this, subjects must have an fev1 equal to or greater than 80% of predicted value and have a normal fev1/fvc ratio.
boolean
C1708335 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0748133 (UMLS CUI [4])
C1287681 (UMLS CUI [5])
Asthma | Reversibility FEV1 | Volume expired during 1.0 s of forced expiration^ pre dose methacholine:Vol:Pt:Respiratory system:Qn | Methacholine
Item
asthma subjects eligible asthmatic participants must have a physician diagnosis of asthma for at least 1 year. participants must either have historical evidence of reversibility of fev1 of at least 12%, or demonstrate such a change during the study visits, or must have historical evidence of a pc20 for methacholine < 8mg/ml.
boolean
C0004096 (UMLS CUI [1])
C0449261 (UMLS CUI [2,1])
C0748133 (UMLS CUI [2,2])
C1714620 (UMLS CUI [3])
C0600370 (UMLS CUI [4])
Mild asthma | Steroids | Adrenergic beta-2 Receptor Agonists | Leukotriene Antagonists | inhaled steroids
Item
mild asthma with no corticosteroids (manc) will be defined as control of asthma with short acting β2-agonists or leukotrine antagonist or both, but not requiring inhaled corticosteroids.
boolean
C0581124 (UMLS CUI [1])
C0038317 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
C0595726 (UMLS CUI [4])
C2065041 (UMLS CUI [5])
Mild persistent asthma | Moderate persistent asthma | inhaled steroids | fluticasone | Adrenergic beta-2 Receptor Agonists
Item
mild to moderate asthma (mma) will be defined as control of asthma with an inhaled corticosteroid (less than or equal to 250 mcg daily inhaled fluticasone equivalent) in addition to the medications listed in the manc group or long acting β2-agonists.
boolean
C1960046 (UMLS CUI [1])
C1960047 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0082607 (UMLS CUI [4])
C2936789 (UMLS CUI [5])
Severe asthma
Item
severe asthma (sa) will be defined according to the ats criteria for refractory asthma (10)
boolean
C0581126 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
exclusion criteria apply for all subjects:
boolean
C0680251 (UMLS CUI [1])
Current Smoker | Former smoker Smoking cigarettes: ____ pack-years history | QUIT
Item
current smoker, or former smoker with >10 pack years history or having quit within the past year
boolean
C3241966 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C2230126 (UMLS CUI [2,2])
C0748223 (UMLS CUI [3])
Exacerbation of asthma | Adrenal Cortex Hormones
Item
asthma exacerbation, requiring a new or increased dose of oral corticosteroids, within the past 30 days
boolean
C0349790 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Uncontrolled | Diabetic - poor control | Coronary Artery Disease | Uncontrolled hypertension
Item
significant/uncontrolled medical condition (uncontrolled diabetes, coronary artery disease, uncontrolled hypertension)
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
Pulmonary Emphysema | Lung diseases
Item
diagnosis of emphysema or other significant pulmonary disease
boolean
C0034067 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
Comorbidity | Bronchoscopy Compliance behavior Limited
Item
if, in the opinion of the pi (wjc) the subject has co-morbid conditions that make them unsafe to undergo bronchoscopy, subjects will be given the choice to withdraw from the study or allowed to complete visits 1-3 only.
boolean
C0009488 (UMLS CUI [1])
C0006290 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
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