Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

Sponsor
Novartis
Study ID
NCT00264849
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.
  • Optimized asthma therapy — OTHER
    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.

Study Details

Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma. THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.

Key Dates

Start date
Nov 30, 2005
Status verified
Apr 2018
Primary completion
Sep 30, 2008
Completion
Sep 30, 2008

Study Design

Enrollment
406 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) [ Time Frame: Weeks 16 and 32 ]

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