Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy

Conditions

• Persistent Allergic Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
• Placebo — DRUG
  The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.

Study Details

This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4 therapy.

Key Dates

Start date

Sep 30, 2010

Status verified

Mar 2015

Primary completion

Oct 31, 2013

Completion

Oct 31, 2013

Study Design

Enrollment

616 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omalizumab
  Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
• Placebo Comparator: Placebo
  The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.

Primary Outcome Measure

Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period [ Time Frame: Baseline, 24 weeks ]