ID

14403

Description

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

Lien

https://clinicaltrials.gov/show/NCT00557700

Mots-clés

  1. 13/04/2016 13/04/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

13 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Asthma NCT00557700

Eligibility Asthma NCT00557700

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00557700
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent
Description

informed consent

Type de données

boolean

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

age

Type de données

boolean

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

asthma

Type de données

boolean

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

non-smoker and smoking history

Type de données

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.
Description

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

Type de données

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.
Description

methacholine neurokinin-a provocation test

Type de données

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.
Description

fev1

Type de données

boolean

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

pregnancy and contraception

Type de données

boolean

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

Exclusion Criteria

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

respiratory infection

Type de données

boolean

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

respiratory diseases

Type de données

boolean

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

participating in another clinical trial

Type de données

boolean

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

clinically relevant systemic diseases, other than asthma

Type de données

boolean

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

abnormal laboratory values

Type de données

boolean

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

alcohol or drug abuse

Type de données

boolean

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

lactation

Type de données

boolean

Alias
UMLS CUI [1]
C0006147

Similar models

Eligibility Asthma NCT00557700

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00557700
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial