ID

43644

Description

A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise; ODM derived from: https://clinicaltrials.gov/show/NCT01435902

Link

https://clinicaltrials.gov/show/NCT01435902

Keywords

  1. 2/15/16 2/15/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Asthma NCT01435902

Eligibility Asthma NCT01435902

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01435902
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatient male or female 12 to 50 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
Description

Fertility Female or Contraception status

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0086287
diagnosis of persistent asthma for at least 6 months
Description

persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C3266628
best pre-bronchodilator fev1 of at least 70%.
Description

pre-bronchodilator fev1

Data type

boolean

Alias
UMLS CUI [1]
C3172227
current use of a low- to moderate-dose inhaled corticosteroid
Description

corticosteroid Inhales drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0556393
ability to withhold albuterol 6 hours prior to visits.
Description

albuterol

Data type

boolean

Alias
UMLS CUI [1]
C0001927
physically able to perform exercise testing on a treadmill when albuterol has been withheld
Description

Pulmonary exercise test

Data type

boolean

Alias
UMLS CUI [1]
C1096466
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
intermittent asthma, seasonal asthma, or exercise-induced asthma only
Description

asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
symptomatic allergic rhinitis and/or thrush
Description

allergic rhinitis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C2607914
UMLS CUI [1,2]
C0231220
abnormal, clinically significant electrocardigraph
Description

Electrocardiography

Data type

boolean

Alias
UMLS CUI [1]
C1623258
respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
Description

respiratory infection; asthma status

Data type

boolean

Alias
UMLS CUI [1]
C0035243
UMLS CUI [2]
C1388876
asthma exacerbation within 12 weeks of first visit
Description

asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0349790
respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
allergy to study drugs or study drug excipients
Description

hypersensitivity drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
concomitant medications that could interact with study medications or affect the course of asthma
Description

concomitant medications

Data type

boolean

Alias
UMLS CUI [1]
C2347852
tobacco use within last year and/or a 10 pack-years history
Description

smoking status

Data type

boolean

Alias
UMLS CUI [1]
C1519386
inability to comply with requirements of the study
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
affiliation with investigator's site (example: family member)
Description

relationship Research Personnel

Data type

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0035173

Similar models

Eligibility Asthma NCT01435902

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01435902
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
outpatient male or female 12 to 50 years of age
boolean
C0001779 (UMLS CUI [1])
Fertility Female or Contraception status
Item
females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
boolean
C0015895 (UMLS CUI [1,1])
C0086287 (UMLS CUI [1,2])
persistent asthma
Item
diagnosis of persistent asthma for at least 6 months
boolean
C3266628 (UMLS CUI [1])
pre-bronchodilator fev1
Item
best pre-bronchodilator fev1 of at least 70%.
boolean
C3172227 (UMLS CUI [1])
corticosteroid Inhales drugs
Item
current use of a low- to moderate-dose inhaled corticosteroid
boolean
C0001617 (UMLS CUI [1,1])
C0556393 (UMLS CUI [1,2])
albuterol
Item
ability to withhold albuterol 6 hours prior to visits.
boolean
C0001927 (UMLS CUI [1])
Pulmonary exercise test
Item
physically able to perform exercise testing on a treadmill when albuterol has been withheld
boolean
C1096466 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
asthma
Item
intermittent asthma, seasonal asthma, or exercise-induced asthma only
boolean
C0004096 (UMLS CUI [1])
allergic rhinitis Symptomatic
Item
symptomatic allergic rhinitis and/or thrush
boolean
C2607914 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Electrocardiography
Item
abnormal, clinically significant electrocardigraph
boolean
C1623258 (UMLS CUI [1])
respiratory infection; asthma status
Item
respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
boolean
C0035243 (UMLS CUI [1])
C1388876 (UMLS CUI [2])
asthma exacerbation
Item
asthma exacerbation within 12 weeks of first visit
boolean
C0349790 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Study Subject Participation Status
Item
investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
boolean
C2348568 (UMLS CUI [1])
hypersensitivity drugs
Item
allergy to study drugs or study drug excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
concomitant medications
Item
concomitant medications that could interact with study medications or affect the course of asthma
boolean
C2347852 (UMLS CUI [1])
smoking status
Item
tobacco use within last year and/or a 10 pack-years history
boolean
C1519386 (UMLS CUI [1])
Compliance behavior
Item
inability to comply with requirements of the study
boolean
C1321605 (UMLS CUI [1])
relationship Research Personnel
Item
affiliation with investigator's site (example: family member)
boolean
C0439849 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])

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