Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01007149
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • omalizumab — DRUG
    Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.
  • Placebo — DRUG
    Placebo was supplied in vials with solution for subcutaneous injection.

Study Details

This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.

Key Dates

Start date
Sep 30, 2009
Status verified
Jul 2012
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Omalizumab
    Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
  • Placebo Comparator: Placebo
    Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.

Primary Outcome Measure

Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils [ Time Frame: Baseline and 16 weeks ]

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