Phase 4
Completed N=271
Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
Persistent Allergic Asthma
Source: ClinicalTrials.gov NCT00870584 ↗
Enrolled (actual)
271
Serious AEs
2.9%
Results posted
Nov 2011
Primary outcomePrimary: Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment — 5.2; 4.7 Score on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment |
5.2; 4.7 | — |
| SECONDARY Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks |
26; 19; 44; 44; 29; 30 | — |
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
Data sourced from ClinicalTrials.gov (NCT00870584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.