ID

14406

Description

Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD; ODM derived from: https://clinicaltrials.gov/show/NCT00583986

Link

https://clinicaltrials.gov/show/NCT00583986

Keywords

Versions (1)
  1. 4/13/16 4/13/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 13, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00583986

English

Eligibility Asthma NCT00583986

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00583986
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must have a documented diagnosis of asthma or copd for a minimum of 6 months.
Description

asthma or copd

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C0040223
subject must have stable baseline asthma or copd and have been using a beta-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months.
Description

stable asthma or copd

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0001644
UMLS CUI [4]
C0003209
subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
Description

good health

Data type

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0205170
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female subject who is pregnant or lactating.
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subject who has a history of hospitalization for asthma or copd within 45 days.
Description

hospitalization for asthma or copd

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0024117
UMLS CUI [3]
C0040223
subject with currently diagnosed life-threatening asthma or copd, defined as a history of asthma or copd episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior.
Description

life-threatening asthma or copd, defined as a history of asthma or copd episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C2826244
UMLS CUI [3]
C0021925
UMLS CUI [4]
C0020440
UMLS CUI [5]
C0162297
UMLS CUI [6]
C1843573
subject with supplemental oxygen use
Description

supplemental oxygen

Data type

boolean

Alias
UMLS CUI [1]
C2016153
subject with a history of cancer
Description

history of cancer

Data type

boolean

Alias
UMLS CUI [1]
C2735088
subject with hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that currently are not well controlled by medication.
Description

hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders

Data type

boolean

Alias
UMLS CUI [1]
C0020550
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0036572
subject with asthma with a greater than 10-pack per year history of cigarette smoking or use of any tobacco products within 6 months.
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
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Similar models

Eligibility Asthma NCT00583986

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00583986
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
asthma or copd
Item
subject must have a documented diagnosis of asthma or copd for a minimum of 6 months.
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
stable asthma or copd
Item
subject must have stable baseline asthma or copd and have been using a beta-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months.
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0001644 (UMLS CUI [3])
C0003209 (UMLS CUI [4])
good health
Item
subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
boolean
C0018759 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
pregnancy or lactation
Item
female subject who is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hospitalization for asthma or copd
Item
subject who has a history of hospitalization for asthma or copd within 45 days.
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0024117 (UMLS CUI [2,2])
C0040223 (UMLS CUI [3])
life-threatening asthma or copd, defined as a history of asthma or copd episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior
Item
subject with currently diagnosed life-threatening asthma or copd, defined as a history of asthma or copd episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0021925 (UMLS CUI [3])
C0020440 (UMLS CUI [4])
C0162297 (UMLS CUI [5])
C1843573 (UMLS CUI [6])
supplemental oxygen
Item
subject with supplemental oxygen use
boolean
C2016153 (UMLS CUI [1])
history of cancer
Item
subject with a history of cancer
boolean
C2735088 (UMLS CUI [1])
hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders
Item
subject with hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that currently are not well controlled by medication.
boolean
C0020550 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0036572 (UMLS CUI [5])
smoking history
Item
subject with asthma with a greater than 10-pack per year history of cigarette smoking or use of any tobacco products within 6 months.
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
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