ID

14296

Description

Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00380354

Lien

https://clinicaltrials.gov/show/NCT00380354

Mots-clés

  1. 07/04/2016 07/04/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

7 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

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Eligibility Asthma NCT00380354

Eligibility Asthma NCT00380354

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00380354
Criteria
Description

Criteria

documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
Description

bronchial asthma

Type de données

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0001644
pre-bronchodilator fev1 >75% of predicted at screening.
Description

pre-bronchodilator fev1

Type de données

boolean

Alias
UMLS CUI [1]
C3172227
non-smoker
Description

non-smoker

Type de données

boolean

Alias
UMLS CUI [1]
C0337672
demonstration of a positive reaction to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair on skin prick testing at screening, or within 12 months of study start.
Description

allergic reaction

Type de données

boolean

Alias
UMLS CUI [1]
C1527304
have asthmatic response
Description

asthmatic response

Type de données

boolean

able and willing to give written informed consent to take part in the study.
Description

written informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
available to complete all study measurements.
Description

compliance

Type de données

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiovascular disease
Description

cardiovascular disease

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
clinically significant abnormalities in safety laboratory analysis at screening including any subject who has greater than "trace urine protein levels" following urinalysis at screening.
Description

urine protein levels

Type de données

boolean

Alias
UMLS CUI [1]
C0262923
history of hayfever
Description

hayfever

Type de données

boolean

Alias
UMLS CUI [1]
C0018621
the subject has tested positive for hepatitis c antibody or hepatitis b surface antigen.
Description

hepatitis b or c

Type de données

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
the subject has tested positive for hiv antibodies.
Description

hiv

Type de données

boolean

Alias
UMLS CUI [1]
C0019682
the subject has positive drugs of abuse test.
Description

positive drugs of abuse test

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
subjects weighing less than 50kg are to be excluded from participating in the study.
Description

body weight

Type de données

boolean

Alias
UMLS CUI [1]
C0005910
the subject has participated in a study with a new molecular entity during the previous 3 months.
Description

participated in a study with a new molecular entity

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
history of being unable to tolerate or complete methacholine, and/or allergen challenge tests.
Description

methacholine or allergen challenge tests

Type de données

boolean

Alias
UMLS CUI [1,1]
C0430567
UMLS CUI [1,2]
C1704410
UMLS CUI [2,1]
C0449891
UMLS CUI [2,2]
C1704410
there is a risk of non-compliance with study medication or study procedures.
Description

non-compliance

Type de données

boolean

Alias
UMLS CUI [1]
C1321605
history of blood donation (450 ml) within 2 months of starting the clinical study.
Description

blood donation

Type de données

boolean

Alias
UMLS CUI [1]
C0005794
the subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. one unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
Description

alcohol consumption

Type de données

boolean

Alias
UMLS CUI [1]
C0001948

Similar models

Eligibility Asthma NCT00380354

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00380354
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
bronchial asthma
Item
documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
boolean
C0004096 (UMLS CUI [1])
C0001644 (UMLS CUI [2])
pre-bronchodilator fev1
Item
pre-bronchodilator fev1 >75% of predicted at screening.
boolean
C3172227 (UMLS CUI [1])
non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
allergic reaction
Item
demonstration of a positive reaction to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair on skin prick testing at screening, or within 12 months of study start.
boolean
C1527304 (UMLS CUI [1])
asthmatic response
Item
have asthmatic response
boolean
written informed consent
Item
able and willing to give written informed consent to take part in the study.
boolean
C0021430 (UMLS CUI [1])
compliance
Item
available to complete all study measurements.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cardiovascular disease
Item
history of cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
urine protein levels
Item
clinically significant abnormalities in safety laboratory analysis at screening including any subject who has greater than "trace urine protein levels" following urinalysis at screening.
boolean
C0262923 (UMLS CUI [1])
hayfever
Item
history of hayfever
boolean
C0018621 (UMLS CUI [1])
hepatitis b or c
Item
the subject has tested positive for hepatitis c antibody or hepatitis b surface antigen.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
hiv
Item
the subject has tested positive for hiv antibodies.
boolean
C0019682 (UMLS CUI [1])
positive drugs of abuse test
Item
the subject has positive drugs of abuse test.
boolean
C0038586 (UMLS CUI [1])
body weight
Item
subjects weighing less than 50kg are to be excluded from participating in the study.
boolean
C0005910 (UMLS CUI [1])
participated in a study with a new molecular entity
Item
the subject has participated in a study with a new molecular entity during the previous 3 months.
boolean
C2348568 (UMLS CUI [1])
methacholine or allergen challenge tests
Item
history of being unable to tolerate or complete methacholine, and/or allergen challenge tests.
boolean
C0430567 (UMLS CUI [1,1])
C1704410 (UMLS CUI [1,2])
C0449891 (UMLS CUI [2,1])
C1704410 (UMLS CUI [2,2])
non-compliance
Item
there is a risk of non-compliance with study medication or study procedures.
boolean
C1321605 (UMLS CUI [1])
blood donation
Item
history of blood donation (450 ml) within 2 months of starting the clinical study.
boolean
C0005794 (UMLS CUI [1])
alcohol consumption
Item
the subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. one unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
boolean
C0001948 (UMLS CUI [1])

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