Status:
COMPLETED
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Lead Sponsor:
Novartis
Collaborating Sponsors:
Genentech, Inc.
Tanox
Conditions:
Asthma
Eligibility:
All Genders
12-75 years
Phase:
PHASE4
Brief Summary
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time ...
Eligibility Criteria
Inclusion
- Patients who met the following criteria were included:
- Males or females of any race, who were 12-75 years of age
- A body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml
- 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
- 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
- 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
- An FEV1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
- 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
- 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
- Evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation
Exclusion
- Patients who met the following criteria were excluded:
- Had received systemic corticosteroids for reasons other than asthma within 4 weeks of Visit 1
- A smoking history \>10 pack years
- An active lung disease other than allergic asthma
- Elevated serum IgE levels for reasons other than allergy
- Patients with significant underlying medical conditions
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT00264849
Start Date
November 1 2005
End Date
September 1 2008
Last Update
June 29 2018
Active Locations (17)
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1
Brussels, Belgium
2
Montreal, Canada
3
Hvidovre, Denmark
4
Berlin, Germany