A 26-week Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
Overview
- Phase
- Phase 4
- Intervention
- Omalizumab
- Conditions
- Persistent Allergic Asthma
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 271
- Locations
- 50
- Primary Endpoint
- Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Omalizumab
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.
Intervention: Omalizumab
Placebo
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
Time Frame: Baseline and 24 weeks
The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged \>= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.
Secondary Outcomes
- Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks(24 weeks)