Phase 4 N=271 Randomized Double-blind Treatment

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

Persistent Allergic Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00870584 ↗

Enrolled (actual)

271

Serious AEs

2.9%

Results posted

Nov 2011

Primary outcome: Primary: Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment — 5.2; 4.7 Score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Omalizumab (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Mar 2010

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	—

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

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

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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.