Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

Novartis

Status and phase: Completed; Phase 4

Conditions: Persistent Allergic Asthma

Treatments: Drug: Omalizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00870584

CIGE025AUS33

Details and patient eligibility

About

This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines

Enrollment: 271 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average:

  • Symptoms > 2 days/week
  • Night-time awakenings ≥1 time/week
  • Short-acting beta2-agonist (SABA) use for symptom control >2 days/week forced expiratory volume in 1 second (FEV1) ≤ 80% predicted

Exclusion criteria

• History of intubation for asthma.
• An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
• Less than 3 months of stable maintenance oral corticosteroid therapy for asthma

Other protocol-defined inclusion/exclusion criteria applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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271 participants in 2 patient groups, including a placebo group

Omalizumab

Experimental group

Description:

The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.

Treatment:

Drug: Omalizumab

Placebo

Placebo Comparator group

Description:

Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.

Treatment:

Drug: Placebo