ID

14433

Descrição

Evaluation of Dupilumab in Patients With Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02414854

Link

https://clinicaltrials.gov/show/NCT02414854

Palavras-chave

Versões (1)
  1. 15/04/2016 15/04/2016 -
Transferido a

15 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Asthma NCT02414854

Inglês

Eligibility Asthma NCT02414854

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02414854
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults and adolescent patients with a physician diagnosis of asthma for ≥12 months, based on the global initiative for asthma (gina) 2014 guidelines and the following criteria:
Descrição

Asthma | Adult | Adolescent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0001675
UMLS CUI [3]
C0205653
existing treatment with medium to high dose ics (≥250 mcg of fluticasone propionate twice daily or equipotent ics daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to visit 1.
Descrição

Therapeutic procedure inhaled steroids | Fluticasone propionate | Adrenergic beta-Agonists | Leukotriene Antagonists

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2065041
UMLS CUI [2]
C0117996
UMLS CUI [3]
C0001644
UMLS CUI [4]
C0595726
note for japan: for subjects aged 18 years and older, ics must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for subjects aged 12 to 17 years, ics must be ≥100 mcg of fluticasone propionate twice daily or equivalent).
Descrição

Japan | Age | inhaled steroids | Fluticasone propionate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022341
UMLS CUI [2]
C0001779
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0117996
patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose
Descrição

Asthma | Third control Pharmaceutical Preparations

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0205437
UMLS CUI [2,2]
C0243148
UMLS CUI [2,3]
C0013227
≥1 month prior to visit 1.
Descrição

Patient Visit

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512346
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are ≥18 years of age).
Descrição

Age | Adolescent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0205653
weight is less than 30 kilograms.
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, churg-strauss syndrome, etc) which may impair lung function.
Descrição

Chronic Obstructive Airway Disease | Lung diseases | Hamman-Rich syndrome | Churg-Strauss Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0085786
UMLS CUI [4]
C0008728
a subject who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the screening visit up to and including the baseline visit).
Descrição

Exacerbation of severe persistent asthma | Emergency treatment | Hospitalization Asthma | systemic steroids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3508930
UMLS CUI [2]
C0013969
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0004096
UMLS CUI [4]
C2825233
clinical evidence or imaging (eg, chest x-ray, computed tomography) within 12 months of visit 1 consistent with lung disease(s) other than asthma.
Descrição

Lung diseases | Asthma | Plain chest X-ray | X-Ray Computed Tomography

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0039985
UMLS CUI [4]
C0040405
current smoker or cessation of smoking within 6 months prior to visit 1.
Descrição

Current Smoker | Stopped smoking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C0425310
previous smoker with a smoking history >10 pack-years.
Descrição

Former smoker Smoking cigarettes: ____ pack-years history

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C2230126
comorbid disease that might interfere with the evaluation of investigational medicinal product.
Descrição

Comorbidity Affecting Drug Evaluation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0013175
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Asthma NCT02414854

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02414854
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Asthma | Adult | Adolescent
Item
adults and adolescent patients with a physician diagnosis of asthma for ≥12 months, based on the global initiative for asthma (gina) 2014 guidelines and the following criteria:
boolean
C0004096 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C0205653 (UMLS CUI [3])
Therapeutic procedure inhaled steroids | Fluticasone propionate | Adrenergic beta-Agonists | Leukotriene Antagonists
Item
existing treatment with medium to high dose ics (≥250 mcg of fluticasone propionate twice daily or equipotent ics daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to visit 1.
boolean
C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0117996 (UMLS CUI [2])
C0001644 (UMLS CUI [3])
C0595726 (UMLS CUI [4])
Japan | Age | inhaled steroids | Fluticasone propionate
Item
note for japan: for subjects aged 18 years and older, ics must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for subjects aged 12 to 17 years, ics must be ≥100 mcg of fluticasone propionate twice daily or equivalent).
boolean
C0022341 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0117996 (UMLS CUI [4])
Asthma | Third control Pharmaceutical Preparations
Item
patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose
boolean
C0004096 (UMLS CUI [1])
C0205437 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Patient Visit
Item
≥1 month prior to visit 1.
boolean
C1512346 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age | Adolescent
Item
patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are ≥18 years of age).
boolean
C0001779 (UMLS CUI [1])
C0205653 (UMLS CUI [2])
Body Weight
Item
weight is less than 30 kilograms.
boolean
C0005910 (UMLS CUI [1])
Chronic Obstructive Airway Disease | Lung diseases | Hamman-Rich syndrome | Churg-Strauss Syndrome
Item
chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, churg-strauss syndrome, etc) which may impair lung function.
boolean
C0024117 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0085786 (UMLS CUI [3])
C0008728 (UMLS CUI [4])
Exacerbation of severe persistent asthma | Emergency treatment | Hospitalization Asthma | systemic steroids
Item
a subject who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the screening visit up to and including the baseline visit).
boolean
C3508930 (UMLS CUI [1])
C0013969 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C2825233 (UMLS CUI [4])
Lung diseases | Asthma | Plain chest X-ray | X-Ray Computed Tomography
Item
clinical evidence or imaging (eg, chest x-ray, computed tomography) within 12 months of visit 1 consistent with lung disease(s) other than asthma.
boolean
C0024115 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0039985 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
Current Smoker | Stopped smoking
Item
current smoker or cessation of smoking within 6 months prior to visit 1.
boolean
C3241966 (UMLS CUI [1])
C0425310 (UMLS CUI [2])
Former smoker Smoking cigarettes: ____ pack-years history
Item
previous smoker with a smoking history >10 pack-years.
boolean
C0337671 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])
Comorbidity Affecting Drug Evaluation
Item
comorbid disease that might interfere with the evaluation of investigational medicinal product.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0013175 (UMLS CUI [1,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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