ID

14275

Description

Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00264849

Link

https://clinicaltrials.gov/show/NCT00264849

Keywords

Versions (1)
  1. 4/7/16 4/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 7, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00264849

English

Eligibility Asthma NCT00264849

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00264849
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who met the following criteria were included:
Description

ID.1

Data type

boolean

males or females of any race, who were 12-75 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
a body weight ≥ 20 kg and ≤ 150 kg and with a total serum ige level ≥ 30 to ≤ 700 iu/ml
Description

body weight and serum ige level

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C2229760
a diagnosis of allergic asthma ≥ 1 year duration according to american thoracic society (ats) criteria and at screening a history consistent with gina (2204) step 3 or 4 clinical features
Description

allergic asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C0449238
a positive prick skin test (diameter of wheal >= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1
Description

prick skin test

Data type

boolean

Alias
UMLS CUI [1]
C0430561
increase in fev1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg
Description

fev1

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0001927
an fev1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
receiving moderate to high dose inhaled corticosteroid ≥ 800 µg bdp or equivalent and a regular inhaled long acting b-2 agonists for at least 3 months prior to screening and > 1000 µg (bdp) and a laba for at least 4 weeks during the run-in and at randomization
Description

inhaled corticosteroid, inhaled long acting beta2 agonists, bdp, laba

Data type

boolean

Alias
UMLS CUI [1]
C0586793
UMLS CUI [2]
C2936789
patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ics (≥ 800 µg bdp or equivalent) plus regular inhaled laba
Description

asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C3248292
UMLS CUI [3,1]
C2936789
UMLS CUI [3,2]
C0040223
evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation
Description

poor asthma control

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2700379
UMLS CUI [1,3]
C2587213
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who met the following criteria were excluded:
Description

ID.11

Data type

boolean

had received systemic corticosteroids for reasons other than asthma within 4 weeks of visit 1
Description

systemic corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C4039704
a smoking history >10 pack years
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
an active lung disease other than allergic asthma
Description

lung disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
elevated serum ige levels for reasons other than allergy
Description

serum ige levels

Data type

boolean

Alias
UMLS CUI [1]
C2229760
patients with significant underlying medical conditions
Description

significant underlying medical conditions

Data type

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Asthma NCT00264849

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00264849
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patients who met the following criteria were included:
boolean
age
Item
males or females of any race, who were 12-75 years of age
boolean
C0001779 (UMLS CUI [1])
body weight and serum ige level
Item
a body weight ≥ 20 kg and ≤ 150 kg and with a total serum ige level ≥ 30 to ≤ 700 iu/ml
boolean
C0005910 (UMLS CUI [1])
C2229760 (UMLS CUI [2])
allergic asthma
Item
a diagnosis of allergic asthma ≥ 1 year duration according to american thoracic society (ats) criteria and at screening a history consistent with gina (2204) step 3 or 4 clinical features
boolean
C0155877 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
prick skin test
Item
a positive prick skin test (diameter of wheal >= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1
boolean
C0430561 (UMLS CUI [1])
fev1
Item
increase in fev1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg
boolean
C0748133 (UMLS CUI [1,1])
C0001927 (UMLS CUI [1,2])
fev1
Item
an fev1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
boolean
C0748133 (UMLS CUI [1])
inhaled corticosteroid, inhaled long acting beta2 agonists, bdp, laba
Item
receiving moderate to high dose inhaled corticosteroid ≥ 800 µg bdp or equivalent and a regular inhaled long acting b-2 agonists for at least 3 months prior to screening and > 1000 µg (bdp) and a laba for at least 4 weeks during the run-in and at randomization
boolean
C0586793 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
asthma exacerbation
Item
patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ics (≥ 800 µg bdp or equivalent) plus regular inhaled laba
boolean
C0349790 (UMLS CUI [1])
C3248292 (UMLS CUI [2])
C2936789 (UMLS CUI [3,1])
C0040223 (UMLS CUI [3,2])
poor asthma control
Item
evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation
boolean
C0004096 (UMLS CUI [1,1])
C2700379 (UMLS CUI [1,2])
C2587213 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
ID.11
Item
patients who met the following criteria were excluded:
boolean
systemic corticosteroids
Item
had received systemic corticosteroids for reasons other than asthma within 4 weeks of visit 1
boolean
C4039704 (UMLS CUI [1])
smoking history
Item
a smoking history >10 pack years
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
lung disease
Item
an active lung disease other than allergic asthma
boolean
C0024115 (UMLS CUI [1])
serum ige levels
Item
elevated serum ige levels for reasons other than allergy
boolean
C2229760 (UMLS CUI [1])
significant underlying medical conditions
Item
patients with significant underlying medical conditions
boolean
C0009488 (UMLS CUI [1])
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