ID

14069

Description

Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists; ODM derived from: https://clinicaltrials.gov/show/NCT00670930

Link

https://clinicaltrials.gov/show/NCT00670930

Keywords

Versions (1)
  1. 3/24/16 3/24/16 -
Uploaded on

March 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Allergic Asthma NCT00670930

English

Eligibility Allergic Asthma NCT00670930

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day bdp or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
Description

Age | Moderate persistent allergic asthma | Severe persistent allergic asthma | Inhaled corticosteroids | beta-Agonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C4039651
UMLS CUI [1,3]
C4041248
UMLS CUI [1,4]
C3248292
UMLS CUI [1,5]
C0001644
with a body weight between 20 and 150kg and a serum total ige level of 30 to 700 iu/ml
Description

Body weight | serum IgE measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C2229760
with ≥2 percent eosinophilia in induced sputum at screening
Description

Eosinophilia | Sputum, Induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0014457
UMLS CUI [1,2]
C3179346
with post-bronchodilator forced expiratory volume in 1 second (fev1) ≥60 percent predicted
Description

FEV1 | post bronchodilator

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
with a positive skin prick test (diameter of wheal ≥ 3 mm) or rast test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
Description

Skin prick test | Radioallergosorbent Test | Aeroallergen

Data type

boolean

Alias
UMLS CUI [1]
C0034554
UMLS CUI [2,1]
C0430561
UMLS CUI [2,2]
C3827475
UMLS CUI [2,3]
C0001697
UMLS CUI [2,4]
C1275706
UMLS CUI [3]
C0440456
UMLS CUI [4]
C0440458
UMLS CUI [5]
C0009208
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who've had an asthma exacerbation during the 4 weeks prior to randomization
Description

Asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0349790
current smokers, stopped smoking within the last 12 months or have a smoking history of >10 pack years
Description

Current smoker | Stopped smoking

Data type

boolean

Alias
UMLS CUI [1,1]
C3241966
UMLS CUI [1,2]
C0425310
UMLS CUI [1,3]
C2230126
history of severe allergy to food or drugs
Description

Food allergy | Drug allergy

Data type

boolean

Alias
UMLS CUI [1]
C0016470
UMLS CUI [2]
C0013182
previous treatment with omalizumab
Description

Omalizumab | Prior therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0966225
UMLS CUI [1,2]
C1514463
any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator
Description

Bronchoscopy | Patient unsuitable for procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0006290
UMLS CUI [1,2]
C3839996
other protocol-defined inclusion/exclusion criteria applied.
Description

Inclusion criteria | Exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1704756
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Similar models

Eligibility Allergic Asthma NCT00670930

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Moderate persistent allergic asthma | Severe persistent allergic asthma | Inhaled corticosteroids | beta-Agonists
Item
patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day bdp or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
boolean
C0001779 (UMLS CUI [1,1])
C4039651 (UMLS CUI [1,2])
C4041248 (UMLS CUI [1,3])
C3248292 (UMLS CUI [1,4])
C0001644 (UMLS CUI [1,5])
Body weight | serum IgE measurement
Item
with a body weight between 20 and 150kg and a serum total ige level of 30 to 700 iu/ml
boolean
C0005910 (UMLS CUI [1,1])
C2229760 (UMLS CUI [1,2])
Eosinophilia | Sputum, Induced
Item
with ≥2 percent eosinophilia in induced sputum at screening
boolean
C0014457 (UMLS CUI [1,1])
C3179346 (UMLS CUI [1,2])
FEV1 | post bronchodilator
Item
with post-bronchodilator forced expiratory volume in 1 second (fev1) ≥60 percent predicted
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
Skin prick test | Radioallergosorbent Test | Aeroallergen
Item
with a positive skin prick test (diameter of wheal ≥ 3 mm) or rast test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
boolean
C0034554 (UMLS CUI [1])
C0430561 (UMLS CUI [2,1])
C3827475 (UMLS CUI [2,2])
C0001697 (UMLS CUI [2,3])
C1275706 (UMLS CUI [2,4])
C0440456 (UMLS CUI [3])
C0440458 (UMLS CUI [4])
C0009208 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Asthma exacerbation
Item
patients who've had an asthma exacerbation during the 4 weeks prior to randomization
boolean
C0349790 (UMLS CUI [1])
Current smoker | Stopped smoking
Item
current smokers, stopped smoking within the last 12 months or have a smoking history of >10 pack years
boolean
C3241966 (UMLS CUI [1,1])
C0425310 (UMLS CUI [1,2])
C2230126 (UMLS CUI [1,3])
Food allergy | Drug allergy
Item
history of severe allergy to food or drugs
boolean
C0016470 (UMLS CUI [1])
C0013182 (UMLS CUI [2])
Omalizumab | Prior therapy
Item
previous treatment with omalizumab
boolean
C0966225 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Bronchoscopy | Patient unsuitable for procedure
Item
any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator
boolean
C0006290 (UMLS CUI [1,1])
C3839996 (UMLS CUI [1,2])
Inclusion criteria | Exclusion criteria
Item
other protocol-defined inclusion/exclusion criteria applied.
boolean
C1704756 (UMLS CUI [1])
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