A randomized, multi-center, double-blind, placebo-controlled, parallel-group trial to explore the effects of 78 weeks omalizumab treatment as add on therapy on airway inflammation and remodeling in patients with moderate to severe IgE-mediated asthma receiving inhaled corticosteroids and long acting beta-agonists

• Conditions: Asthma

• Registration Number: EUCTR2007-004653-29-FR
• Lead Sponsor: ovartisPharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-26
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Male or female (post menopausal or surgically steralized or using approved contraception) patients with moderate to severe allergic asthma with persistent symptoms depsite receiving an inhaled corticosteroids and long acting beta-agonist.

18-60 years of age, with >= 2% eosinophiila in induced sputum at both screening visits.

Body weight between 20 and 150kg, with a serum total IgE level between 30 and 700 IU/mL.

Patients must have a positive skin prick test or RAST test to at least one perennial aeroallergen documented within the past 2 years, to which the patient will be exposed on a regular basis.

FEV1 must be greater than or equal to 60% of the predicted value for the patient, which must be stable (within 10%) at the second screening visit and the randomization visit.

Patients must be receiving high dose inhaled corticosteroids (at least 800ug per day BDP or equivalent) and a regular inhaled long actin beta-agonist for at least 3 months prior to screening.

Are the trial subjects under 18? no
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Current active smokers or patients with >= 10 pack-year smoking history.

Patients who have been treated for an asthma exacerbation during the 4 weeks prior to randomization.

Patients who have received omalizumab previously.

Patients with elevated serum IgE levels for reasons other than allergy.

Patients with a history of allergic reactions to local anaesthetics to be used during bronchoscopy, any clotting abnormality, history of chronic CO2 retention, and any patient who has been intubated because of the asthma.

Any patient with a current or historial condition that excludes the patient from undergoing bronchoscopy, as assessed by the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified