Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
NCT ID: NCT00264849
Last Updated: 2018-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
406 participants
INTERVENTIONAL
2005-11-30
2008-09-30
Brief Summary
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THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OAT + Omalizumab
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
Omalizumab
Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.
Optimized asthma therapy
Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.
Optimized Asthma Treatment (OAT)
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for 32 weeks.
Optimized asthma therapy
Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.
Interventions
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Omalizumab
Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.
Optimized asthma therapy
Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
12 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Tanox
INDUSTRY
Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Brussels, , Belgium
Montreal, , Canada
Hvidovre, , Denmark
Berlin, , Germany
Athens, , Greece
Budapest, , Hungary
Dublin, , Ireland
Haifa, , Israel
Roma, , Italy
Oslo, , Norway
Lodz, , Poland
Lisbon, , Portugal
Madrid, , Spain
Stockholm, , Sweden
Bern, , Switzerland
Bursa, , Turkey (Türkiye)
Nottingham, , United Kingdom
Countries
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References
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Siergiejko Z, Swiebocka E, Smith N, Peckitt C, Leo J, Peachey G, Maykut R. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin. 2011 Nov;27(11):2223-8. doi: 10.1185/03007995.2011.620950. Epub 2011 Sep 21.
Other Identifiers
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CIGE025A2425
Identifier Type: -
Identifier Source: org_study_id
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