Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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 in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.

Key facts

Study ID

NCT00079937

Run by

Novartis Pharmaceuticals

People needed

628

Starts

2004-04-01

Expected to finish

2008-03-01

Last updated by the study team

2012-04-11

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Clinical Research Center — Little Rock, Arkansas, United States
• Allergy and Asthma Specialists Medical Group — Huntington Beach, California, United States
• Pediatric Care and Medical Group — Huntington Beach, California, United States
• West Coast Clinical Trials — Long Beach, California, United States
• Southern California Research Center — Mission Viejo, California, United States
• Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology — Orange, California, United States
• CA Allergy & Asthma Med Group — Palmdale, California, United States
• Dr. Joann Blessing-Moore — Palo Alto, California, United States
• Integrated Research Group — Riverside, California, United States
• Allergy Associates Medical Group — San Diego, California, United States
• Allergy and Asthma Medical Group & Research Center — San Diego, California, United States
• Allergy and Asthma Associates of Santa Clara Valley RC — San Jose, California, United States
• 1304 15th St — Santa Monica, California, United States
• Bensch Research Associates — Stockton, California, United States
• Allergy & Asthma Med Group of Diablo Valley CR — Walnut Creek, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Miami Children's Hospital — Miami, Florida, United States
• Georgia Pollens — Albany, Georgia, United States
• Family Allergy and Asthma Center, PC — Atlanta, Georgia, United States
• Aeroallergy Research Labs of Savannah, Inc — Savannah, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Asthma & Allergy Center — Elliott, Maryland, United States
• Northeast Med Research Associates — North Dartmouth, Massachusetts, United States
• Alabama Allergy and Asthma Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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