ID

14165

Beskrivning

A Study to Evaluate the Effect of AF-219 on Methacholine Hyper-reactivity in Subjects With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01993329

Länk

https://clinicaltrials.gov/show/NCT01993329

Nyckelord

Versioner (2)
  1. 2016-04-02 2016-04-02 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

2 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Asthma NCT01993329

Engelsk

Eligibility Asthma NCT01993329

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01993329
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-smokers or former smokers, who stopped smoking 6 months prior to screening. former smokers should not have a smoking history of more than 5 pack years (1 pack of 20 cigarettes per day over 5 years).
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C0425310
UMLS CUI [2,3]
C2230126
pre-bronchodilator (after abstaining from short acting β2-agonist for ≥8 hrs) forced expiratory volume (fev1) ≥70 percent of the predicted normal value at the screening visit.
Beskrivning

FEV1 | pre bronchodilator | Adrenergic beta-2 Receptor Agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
UMLS CUI [2]
C2936789
pre-bronchodilator (after abstaining from short acting β2-agonist for ≥8 hrs) forced expiratory volume (fev1) ≥70% of the predicted normal value or if less than 70% must be within +/- 12 % of screening fev1 prior to randomization.
Beskrivning

FEV1 | pre bronchodilator | Adrenergic beta-2 Receptor Agonists | Trial Screening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
UMLS CUI [2]
C2936789
UMLS CUI [3]
C1710477
history or diagnosis of asthma for at least 6 months prior to screening according to the global initiative in asthma guidelines (gina, 2012).
Beskrivning

Asthma | Before screening procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0220908
use of short acting β2-agonist therapy only (≤ 8 puffs per day) for at least 4 weeks prior to screening and prior to randomisation.
Beskrivning

Adrenergic beta-2 Receptor Agonists | Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2936789
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0220908
UMLS CUI [2]
C0034656
positive response to methacholine challenge (pc20 ≤ 8 mg/ml) at screening.
Beskrivning

Methacholine challenge | Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430567
UMLS CUI [1,2]
C1446409
positive response to atp challenge (pc20 ≤ 200 µmol/ml) at screening.
Beskrivning

Adenosine Triphosphate | Challenge | Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001480
UMLS CUI [1,2]
C0805586
UMLS CUI [1,3]
C1446409
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hospitalized or attended the emergency department for an asthma attack in the 12 months prior to screening.
Beskrivning

Asthma attack | Hospitalization | Emergency room admission

Datatyp

boolean

Alias
UMLS CUI [1]
C0347950
UMLS CUI [2]
C0019993
UMLS CUI [3]
C0583237
exacerbation of asthma or lower respiratory tract infection during the 4 weeks before screening.
Beskrivning

Exacerbation of asthma | Lower respiratory tract infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0149725
upper respiratory tract infection during the 4 weeks before screening or prior to randomization requiring treatment with antibiotics.
Beskrivning

Treatment required for | Upper Respiratory Infections | Antibiotics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332121
UMLS CUI [1,2]
C0041912
UMLS CUI [2]
C0003232
inhaled or systemic corticosteroids (oral, intravenous, intramuscular) within 4 weeks prior to screening.
Beskrivning

Inhaled steroids | systemic steroids | Adrenal Cortex Hormones | Intravenous steroid injection | Intramuscular steroid therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C2825233
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0563322
UMLS CUI [5]
C0585373
short-acting or long-acting antihistamines within 48hrs or 7 days, respectively, prior to screening.
Beskrivning

Antihistamines

Datatyp

boolean

Alias
UMLS CUI [1]
C0003360
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Similar models

Eligibility Asthma NCT01993329

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01993329
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-smoker | Former smoker | Stopped smoking | smoking cigarettes: ____ pack-years history
Item
non-smokers or former smokers, who stopped smoking 6 months prior to screening. former smokers should not have a smoking history of more than 5 pack years (1 pack of 20 cigarettes per day over 5 years).
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C0425310 (UMLS CUI [2,2])
C2230126 (UMLS CUI [2,3])
FEV1 | pre bronchodilator | Adrenergic beta-2 Receptor Agonists
Item
pre-bronchodilator (after abstaining from short acting β2-agonist for ≥8 hrs) forced expiratory volume (fev1) ≥70 percent of the predicted normal value at the screening visit.
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
FEV1 | pre bronchodilator | Adrenergic beta-2 Receptor Agonists | Trial Screening
Item
pre-bronchodilator (after abstaining from short acting β2-agonist for ≥8 hrs) forced expiratory volume (fev1) ≥70% of the predicted normal value or if less than 70% must be within +/- 12 % of screening fev1 prior to randomization.
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
C1710477 (UMLS CUI [3])
Asthma | Before screening procedure
Item
history or diagnosis of asthma for at least 6 months prior to screening according to the global initiative in asthma guidelines (gina, 2012).
boolean
C0004096 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
Adrenergic beta-2 Receptor Agonists | Therapeutic procedure
Item
use of short acting β2-agonist therapy only (≤ 8 puffs per day) for at least 4 weeks prior to screening and prior to randomisation.
boolean
C2936789 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C0034656 (UMLS CUI [2])
Methacholine challenge | Positive
Item
positive response to methacholine challenge (pc20 ≤ 8 mg/ml) at screening.
boolean
C0430567 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Adenosine Triphosphate | Challenge | Positive
Item
positive response to atp challenge (pc20 ≤ 200 µmol/ml) at screening.
boolean
C0001480 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Asthma attack | Hospitalization | Emergency room admission
Item
hospitalized or attended the emergency department for an asthma attack in the 12 months prior to screening.
boolean
C0347950 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0583237 (UMLS CUI [3])
Exacerbation of asthma | Lower respiratory tract infection
Item
exacerbation of asthma or lower respiratory tract infection during the 4 weeks before screening.
boolean
C0349790 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Treatment required for | Upper Respiratory Infections | Antibiotics
Item
upper respiratory tract infection during the 4 weeks before screening or prior to randomization requiring treatment with antibiotics.
boolean
C0332121 (UMLS CUI [1,1])
C0041912 (UMLS CUI [1,2])
C0003232 (UMLS CUI [2])
Inhaled steroids | systemic steroids | Adrenal Cortex Hormones | Intravenous steroid injection | Intramuscular steroid therapy
Item
inhaled or systemic corticosteroids (oral, intravenous, intramuscular) within 4 weeks prior to screening.
boolean
C2065041 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0563322 (UMLS CUI [4])
C0585373 (UMLS CUI [5])
Antihistamines
Item
short-acting or long-acting antihistamines within 48hrs or 7 days, respectively, prior to screening.
boolean
C0003360 (UMLS CUI [1])
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