ID

14403

Beskrivning

Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00557700

Länk

https://clinicaltrials.gov/show/NCT00557700

Nyckelord

Versioner (1)
  1. 2016-04-13 2016-04-13 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

13 april 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00557700

Engelsk

Eligibility Asthma NCT00557700

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00557700
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
male or female, at least 18 years old
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
documented medical history of asthma (diagnosis at least 6 months ago)
Beskrivning

asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
Beskrivning

non-smoker and smoking history

Datatyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C1519384
UMLS CUI [3]
C1277691
able to conduct a technically acceptable spirometry, methacholine and neurokinin-a provocation test.
Beskrivning

able to conduct a technically acceptable spirometry, methacholine and neurokinin-a provocation test

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0037981
UMLS CUI [3]
C0430567
UMLS CUI [4,1]
C0038581
UMLS CUI [4,2]
C0449428
UMLS CUI [4,3]
C0039593
at visit 1: pc20 methacholine ≤ 8 mg/ml and ≤ 3.3x10-7 mol/ml for the neurokinin-a provocation test.
Beskrivning

methacholine neurokinin-a provocation test

Datatyp

boolean

Alias
UMLS CUI [1]
C0600370
UMLS CUI [2]
C0748133
UMLS CUI [3,1]
C0038581
UMLS CUI [3,2]
C0449428
UMLS CUI [3,3]
C0039593
at visit 1: forced expiratory value in one second >= 80% of the predicted value.
Beskrivning

fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
female subjects may not get pregnant and should be using adequate contraception.
Beskrivning

pregnancy and contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
airway infection within 6 weeks prior to first study visit.
Beskrivning

respiratory infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
other respiratory diseases (eg copd, lung cancer, etc.)
Beskrivning

respiratory diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0035204
participating in another clinical trial.
Beskrivning

participating in another clinical trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
clinically relevant systemic diseases, other than asthma.
Beskrivning

clinically relevant systemic diseases, other than asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
clinically significant laboratory deviations.
Beskrivning

abnormal laboratory values

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
alcohol or drug abuse.
Beskrivning

alcohol or drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
female subjects who are lactating.
Beskrivning

lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Asthma NCT00557700

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00557700
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
age
Item
male or female, at least 18 years old
boolean
C0001779 (UMLS CUI [1])
asthma
Item
documented medical history of asthma (diagnosis at least 6 months ago)
boolean
C0004096 (UMLS CUI [1])
non-smoker and smoking history
Item
non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
boolean
C0337672 (UMLS CUI [1])
C1519384 (UMLS CUI [2])
C1277691 (UMLS CUI [3])
able to conduct a technically acceptable spirometry, methacholine and neurokinin-a provocation test
Item
able to conduct a technically acceptable spirometry, methacholine and neurokinin-a provocation test.
boolean
C1321605 (UMLS CUI [1])
C0037981 (UMLS CUI [2])
C0430567 (UMLS CUI [3])
C0038581 (UMLS CUI [4,1])
C0449428 (UMLS CUI [4,2])
C0039593 (UMLS CUI [4,3])
methacholine neurokinin-a provocation test
Item
at visit 1: pc20 methacholine ≤ 8 mg/ml and ≤ 3.3x10-7 mol/ml for the neurokinin-a provocation test.
boolean
C0600370 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0038581 (UMLS CUI [3,1])
C0449428 (UMLS CUI [3,2])
C0039593 (UMLS CUI [3,3])
fev1
Item
at visit 1: forced expiratory value in one second >= 80% of the predicted value.
boolean
C0748133 (UMLS CUI [1])
pregnancy and contraception
Item
female subjects may not get pregnant and should be using adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
respiratory infection
Item
airway infection within 6 weeks prior to first study visit.
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
respiratory diseases
Item
other respiratory diseases (eg copd, lung cancer, etc.)
boolean
C0035204 (UMLS CUI [1])
participating in another clinical trial
Item
participating in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
clinically relevant systemic diseases, other than asthma
Item
clinically relevant systemic diseases, other than asthma.
boolean
C0009488 (UMLS CUI [1])
abnormal laboratory values
Item
clinically significant laboratory deviations.
boolean
C1254595 (UMLS CUI [1])
alcohol or drug abuse
Item
alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1])
lactation
Item
female subjects who are lactating.
boolean
C0006147 (UMLS CUI [1])
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