Status:
COMPLETED
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief Summary
A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE i...
Detailed Description
This study was designed to provide one year efficacy and safety data for subcutaneous (SC) omalizumab, compared to placebo in children (6 to \< 12 years) with moderate to severe persistent asthma who ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Parent or legal guardian was informed of the study procedures and medications and gave written informed consent.
- Outpatient males and females aged 6 - \< 12 years on study entry, with body weight between 20 and 150 kg.
- Total serum IgE level ≥ 30 to ≤ 1300 IU.
- Diagnosis of allergic asthma ≥ 1 year duration, according to American Thoracic Society (ATS) criteria, and a screening history consistent with clinical features of moderate or severe persistent asthma according to National Heart Lung and Blood Institute (NHLBI) guidelines.
- Positive prick skin test to at least one perennial allergen, documented within the past 2 years or taken at Screening. A radioallergosorbent test (RAST) could have been performed for patients with a borderline skin prick test result after consultation with Novartis clinical personnel.
- Patients with ≥ 12% increase in forced expiratory volume in 1 second (FEV1) over starting value within 30 minutes of taking up to 4 puffs (4x100 µg) salbutamol (albuterol) or nebulized salbutamol up to 5 mg (or equivalent of alternative B2-agonist) documented within the past year, at screening, during the run-in period, or prior to randomization. Patients were not to take their long acting B2-agonist (LABA) medication within 12 hours of reversibility testing.
- Clinical features of moderate or severe persistent asthma (at least step 3) despite therapy at step 3 or 4 (at least medium dose inhaled corticosteroid (ICS) - fluticasone dry-powder inhaler (DPI) ≥ 200 mg/day or equivalent with or without other controller medications).
- Documented history of experiencing asthma exacerbations and demonstrated inadequate symptom control during the last 4 weeks of run-in despite receiving an equivalent dose of fluticasone DPI ≥ 200 mg/day total daily ex-valve dose.
- Exclusion criteria:
- Patients who received systemic corticosteroids for reasons other than asthma, beta-adrenergic antagonists by any route, anticholinergics within 24 hours of Screening, methotrexate, gold salts, cyclosporin or troleandomycin, or had received desensitization therapy with less than 3 months of stable maintenance doses prior to Screening.
- Patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction, a history of allergy to antibiotics, with aspirin or other non-steroidal anti-inflammatory drugs (NSAID)-related asthma (unless the NSAID could be avoided), with active lung disease or acute sinusitis/chest infection, elevated serum IgE levels for other reasons, presence/history of a clinically significant uncontrolled systemic disease, cancer, abnormal, electrocardiogram (ECG) in the previous month, or platelets ≤ 100 x 109/L or clinically significant laboratory abnormalities at Screening.
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT00079937
Start Date
April 1 2004
End Date
March 1 2008
Last Update
April 11 2012
Active Locations (56)
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1
Alabama Allergy and Asthma Center
Birmingham, Alabama, United States, 35209
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
3
Clinical Research Center
Little Rock, Arkansas, United States, 72205
4
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, United States, 92647