Phase 4
N=406
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00264849 ↗Enrolled (actual)
406
Serious AEs
11.4%
Results posted
Jul 2011
Primary outcome: Primary: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) — 190; 29; 187; 28 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omalizumab (Drug); Optimized asthma therapy (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) |
190; 29; 187; 28; 171; 18 | — |
| SECONDARY Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32 |
35; 1; 155; 28; 57; 24 | — |
| SECONDARY Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE |
62.9; 14.1 | — |
| SECONDARY Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32 |
54; 4; 139; 29; 53; 23 | — |
| SECONDARY Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE |
63.2; 15.6 | — |
| SECONDARY Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1) |
68.4; 64.8; 68.1; 63.7 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32 |
-0.78; -0.11; -0.91; -0.04; -0.84; 0.07 | — |
| SECONDARY Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period |
183; 64; 58; 35; 18; 17 | — |
| SECONDARY Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period |
226; 86; 26; 12; 10; 17 | — |
| SECONDARY Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32 |
-20.1; 36.8; -45.0; 18.3 | — |
| SECONDARY Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32 |
10; 2; 14; 2; 32; 15 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit |
0.90; 0.03; 1.06; -0.07; 0.89; -0.05 | — |
| SECONDARY Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31 |
0.071; 0.002; 0.091; 0.064; 8.2; -0.4 | — |
| SECONDARY Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems |
41.3; 39.4; 20.5; 40.3; -20.8; 0.8 | — |
Summary
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.
Eligibility Criteria
Inclusion Criteria
Patients who met the following criteria were included:
- Males or females of any race, who were 12-75 years of age
- A body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml
- A diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria and at screening a history consistent with GINA (2204) step 3 or 4 clinical features
- A positive prick skin test (diameter of wheal >= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1
- Increase in FEV1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg
- An FEV1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
- Receiving moderate to high dose inhaled corticosteroid ≥ 800 µg BDP or equivalent and a regular inhaled long acting B-2 agonists for at least 3 months prior to screening and > 1000 µg (BDP) and a LABA for at least 4 weeks during the run-in and at randomization
- Patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ICS (≥ 800 µg BDP or equivalent) plus regular inhaled LABA
- Evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation
Exclusion Criteria
Patients who met the following criteria were excluded:
- Had received systemic corticosteroids for reasons other than asthma within 4 weeks of Visit 1
- A smoking history >10 pack years
- An active lung disease other than allergic asthma
- Elevated serum IgE levels for reasons other than allergy
- Patients with significant underlying medical conditions
Data sourced from ClinicalTrials.gov (NCT00264849). 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.