Phase 3
N=616
Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
Persistent Allergic Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01202903 ↗Enrolled (actual)
616
Serious AEs
3.1%
Results posted
Mar 2015
Primary outcome: Primary: Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period — 27.03; 18.18 L/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omalizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period |
27.03; 18.18 | — |
| SECONDARY Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment |
22.96; 15.53 | — |
| SECONDARY Change From Baseline in % Predicted FEV1 Following 24-week Treatment |
19.113; 14.989 | — |
| SECONDARY Change From Baseline in AQLQ Score Following 24-week Treatment |
0.51; 0.10; 0.47; 0.18; 0.46; 0.17 | — |
| SECONDARY Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment |
12.1; 10.6; 9.2; 6.6; 13.4; 6.0 | — |
| SECONDARY Change From Baseline in ACQ Score Following 24-week Treatment |
-0.51; -0.34 | — |
| SECONDARY Percentage of Patients With at Least a 0.5 or 0.75 Point Improvement in the ACQ Score at Week 24 |
34; 24.8; 34.6; 45.0; 23.5; 15.2 | — |
| SECONDARY Change From Baseline in Asthma Symptom Scores Following 24-week Treatment |
-1.65; -1.44; -0.67; -0.55; -0.21; -0.20 | — |
| SECONDARY Percentage of Participants With Investigator and Patient Global Evaluation of Treatment Effectiveness (GETE) at Weeks 16 and 24 |
71.9; 52.3; 25.5; 44.4; 2.6; 3.3 | — |
| SECONDARY Change From Baseline in Number of Puffs of Asthma Rescue Medication Following 24-week Treatment |
-1.14; -0.85; -0.53; -0.38; -0.56; -0.42 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Met study drug-dosing table eligibility criteria (serum baseline total IgE level ≥ 30 to ≤ 700 IU/mL and body weight > 20 kg and ≤ 150 kg)
- Diagnosed with asthma ≥ 1 year duration at Screening, and a history of asthma that is not adequately controlled with GINA (2009) Step 4 therapy
- Received medium-to-high dose inhaled corticosteroid > 500 µg Beclomethasone Diproprionate (BDP), or equivalent plus regularly inhaled LABA, either separately or in combination, for at least 8 weeks prior to screening
- Met specific asthma exacerbations eligibility criteria prior to the screening period
- Exhibited inadequate symptom control as demonstrated by specific criteria (in keeping with GINA 2009 guidelines)
- Positive skin prick test to at least one perennial aeroallergen documented by a historical test within 12 months prior to screening, or at Visit 1
- FEV1 ≥ 40% and 10 pack-years. A former smoker must have abstained for a minimum of 12 months before randomization
- Receiving specific medications
- Clinically significant laboratory abnormalities (not associated with the study indication) at Visit 1
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01202903). 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.