A randomized, open label, parallel-group, international, multicenter study evaluating persistency of response to omalizumab during 32 weeks treatment given as add on to optimized asthma therapy in adult and adolescent patients with severe persistent allergic asthma, who remain inadequately controlled despite GINA (2004) step 4 therapy

Conditions: Severe persistent allergic asthma
MedDRA version: 8.1Level: LLTClassification code 10001705Term: Allergic asthma

Registration Number: EUCTR2005-001099-11-GB

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

- males or females of any race who are 12-75 years of age
- body weight 20 to 150 kg and total serum IgE level 30 to 700 IU/ml
- diagnosis of allergic asthma =1 year duration according to ATS criteria and at screening a history consistent with GINA step 3 or 4 clinical features
- positive skin prick test to at least one perennial allergen documented within the past 2 years or taken at Visit 1. Patients with a total IgE level of = 76 IU require an unequivocal positive RAST test to be eligible
- demonstrating at least 12% increase in FEV1 within 30 minutes of taking salbutamol
- FEV1 between 40 and 80% of the predicted normal value for the patient at screening and randomization
- receiving high dose inhaled corticosteroid = 800µg BDP or equivalent and a regular inhaled long acting beta-2 agonist 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
- who have suffered at least two independent documented severe asthma exacerbations while receiving high doses of ICS (= 800 µg BDP or equivalent) plus regular inhaled LABA requiring treatment with systemic (oral or IV) corticosteroids. Qualifying exacerbations must have taken place in the 3 years prior to screening, and at least one severe exacerbation must have occurred within the previous 12 months
- with evidence of poor asthma control at screening and for at least 4 weeks immediately prior to randomization
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- pregnant or nursing women, and women of childbearing potential unless they meet the definition of post-menopausal or use one or more acceptable methods of contraception
Patients :
- who, for reasons other than asthma, have received systemic corticosteroids within 4 weeks of Visit 1 or are likely to require it during the study for reasons other than asthma
- not adhering to the antihistamine washout prior to the skin prick tests at Visit 1
- taking ß adrenergic antagonist medication or anticipate use during the study
- taking methotrexate, gold salts, cyclosporin or troleandomycin within 3 months of Visit 11 (or anticipated their use during the study)
- currently receiving desensitization therapy with less than 3 months of stable maintenance doses prior to the screening visit (Visit 1)
- foreseen to require additional asthma medication during the last 4 weeks of the run-in period
- being treated for an asthma exacerbation during the 4 weeks immediately prior to randomization
- with a smoking history > 10 pack years or an active lung disease other than allergic asthma, e.g. COPD
- with elevated serum IgE levels for reasons other than allergy
- with significant underlying medical conditions that could impact interpretation of results should be excluded (e.g.: infection, hematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
- who have previously been randomized into this or any other omalizumab study or who have received omalizumab (prescribed)