ID

43644

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01435902

Nyckelord

  1. 2016-02-15 2016-02-15 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Asthma NCT01435902

Eligibility Asthma NCT01435902

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

Inclusion Criteria

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

age

Datatyp

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
Beskrivning

Fertility Female or Contraception status

Datatyp

boolean

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

persistent asthma

Datatyp

boolean

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

pre-bronchodilator fev1

Datatyp

boolean

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

corticosteroid Inhales drugs

Datatyp

boolean

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

albuterol

Datatyp

boolean

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

Pulmonary exercise test

Datatyp

boolean

Alias
UMLS CUI [1]
C1096466
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

asthma

Datatyp

boolean

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

allergic rhinitis Symptomatic

Datatyp

boolean

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

Electrocardiography

Datatyp

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
Beskrivning

respiratory infection; asthma status

Datatyp

boolean

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

asthma exacerbation

Datatyp

boolean

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

Compliance behavior Limited Comorbidity

Datatyp

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
Beskrivning

Study Subject Participation Status

Datatyp

boolean

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

hypersensitivity drugs

Datatyp

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
Beskrivning

concomitant medications

Datatyp

boolean

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

smoking status

Datatyp

boolean

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

Compliance behavior

Datatyp

boolean

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

relationship Research Personnel

Datatyp

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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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