Omalizumab in Non-atopic Asthma

Sponsor
King's College London
Study ID
NCT01113437
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Omalizumab or placebo by subcutaneous injections, at 4 weekly or 2 weekly intervals. Dosage is according to manufacturer's guidance and calculated based on body weight and total serum IgE.
  • Placebo — DRUG
    Omalizumab or placebo by subcutaneous injections, at 4 weekly or 2 weekly intervals. Dosage is according to manufacturer's guidance and calculated based on body weight and total serum IgE.

Study Details

Hypothesis- Omalizumab(humanized monoclonal anti-IgE antibody)improves disease control and reduces bronchial mucosal inflammation in non-atopic asthma. In order to test the above hypothesis, the investigators propose a placebo controlled, double blind, parallel group study to obtain proof of principle that omalizumab exerts beneficial effects on disease control in non-atopic severe adult asthmatics aged 18-60 years . Forty patients will be randomized in a 1:1 ratio to receive omalizumab or matching placebo. Following 12 weeks of treatment with omalizumab/placebo, and as this treatment is continued for a further 8 weeks, anti-asthma treatment will be reduced. Dosages will be administered at 4 or 2 weekly intervals over a 16 week period (5 or 10 doses in total), which corresponds with the time stated as necessary to judge efficacy of therapy according to omalizumab's licensed indications in atopic asthma. Efficacy will be judged by clinical monitoring and by bronchial biopsy to assess effects on bronchial inflammation and local IgE production.

Key Dates

Start date
Apr 30, 2010
Status verified
Apr 2010
Primary completion
Aug 31, 2012

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab
    There are 2 arms of the study; patients in one arm receiving omalizumab and in the other arm receiving placebo.
  • Placebo Comparator: Placebo
    There are 2 arms of the study; patients in one arm receiving omalizumab and in the other arm receiving placebo.

Primary Outcome Measure

Pre-bronchodilator FEV1 [ Time Frame: before and after treatment with omalizumab for 16 weeks ]

Central Contacts