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

Condition(s) targeted: Asthma

Intervention: Omalizumab (Drug); placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

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 will test the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

The primary safety objective is to confirm the safety of omalizumab during

the 52 week double-blind treatment period and 16 week follow-up period

The primary efficacy objective is to demonstrate the effect of omalizumab

on the clinically significant asthma exacerbation rate during the 24 week

double-blind fixed steroid treatment

Secondary outcome:

change in nocturnal clinical symptom score (24 week double-blind fixed steroid treatment period)

clinically significant asthma exacerbation rate (52 week double-blind treatment period)

change in beta-agonist rescue medication use (24 week double-blind fixed steroid treatment period)

change in quality of life (24 week double-blind fixed steroid treatment period)

Detailed description: This study is designed to provide one year efficacy and safety data for subcutaneous (SQ) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to NHLBI step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).

Minimum age: 6 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- History of asthma attacks

- Elevated IgE levels

Exclusion Criteria

- History of severe allergy to food or drugs

- Previous treatment with omalizumab

- Very low or high body weight

Other protocol-defined exclusion criteria may apply.

Alabama Allergy and Asthma Center, Birmingham, Alabama 35209, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72202, United States

Clinical Research Center, Little Rock, Arkansas 72205, United States

Allergy and Asthma Associates of Santa Clara Valley RC, San Jose, California 95117, United States

Allergy and Asthma Medical Group & Research Center, San Diego, California 92123, United States

Allergy Associates Medical Group, San Diego, California 92120, United States

Pediatric Care and Medical Group, Huntington Beach, California 92647, United States

Allergy & Asthma Med Group of Diablo Valley CR, Walnut Creek, California 94598, United States

Allergy and Asthma Specialists Medical Group, Huntington Beach, California 92647, United States

Integrated Research Group, Riverside, California 92506, United States

Dr. Joann Blessing-Moore, Palo Alto, California 94304, United States

Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology, Orange, California 92868, United States

West Coast Clinical Trials, Long Beach, California 90806, United States

CA Allergy & Asthma Med Group, Palmdale, California 93551, United States

Southern California Research Center, Mission Viejo, California 92691, United States

Bensch Research Associates, Stockton, California 95207, United States

1304 15th St, Santa Monica, California 90404, United States

National Jewish Medical and Research Center, Denver, Colorado 80206, United States

Miami Children's Hospital, Miami, Florida 33155, United States

Family Allergy and Asthma Center, PC, Atlanta, Georgia 30342, United States

Georgia Pollens, Albany, Georgia 31707, United States

Aeroallergy Research Labs of Savannah, Inc, Savannah, Georgia 31406, United States

Rush University Medical Center, Chicago, Illinois 60612, United States

Asthma & Allergy Center, Elliott City, Maryland 21042, United States

Northeast Med Research Associates, North Dartmouth, Massachusetts 02747, United States

St. Louis University School of Medicine, St. Louis, Missouri 63104, United States

Midwest Allergy & Asthma Clinic, Omaha, Nebraska 68114, United States

Ocean Allergy & Respiratory Research Center, Brick, New Jersey 08724, United States

UMDNJ, Newark, New Jersey 07101, United States

Island Medical Research (Allergy and Asthma Center), Rockville Center, New York 11570, United States

Womes And childrens Hospital of Buffalo, Buffalo, New York 14222, United States

Asthma & Allergy Associates, Ithaca, New York 14850, United States

Allergy and Asthma Diagnostic Office, Liverpool, New York 13088, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Allergy & Asthma Center of North carolina, High Point, North Carolina 27262, United States

Bernstein Clinical Research Center, Cincinnati, Ohio 45231, United States

Resp Dis of Children and Adolescents, Oklahoma City, Oklahoma 73112, United States

Clinical Research Institute of Southern Oregon, medford, Oregon 97504, United States

West Penn Allegheny General Health System, Pittsburgh, Pennsylvania 15212, United States

Asthma and Allergy Associates, Upland, Pennsylvania 19013, United States

501 Howard Av, Altoona, Pennsylvania 16601, United States

AAPRI Clinical Research Institute, Lincoln, Rhode Island 02865, United States

Vanderbilt University, Nashville, Tennessee 37203, United States

Allergy Assoc., The ASthma, Allergy & Sinus Ctr, Knoxville, Tennessee 37922, United States

North Texas Institute for Clinical Trials, Ft. Worth, Texas 76132, United States

Pediatric Allergy/Immunology Associates, PA, Dallas, Texas 75230, United States

Sylvanna Research, San Antonio, Texas 78229, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Pediatric Pulmonary Association of North Texas, Dallas, Texas 75230, United States

7707 Fannin/Ste. 195, Houston, Texas 77054, United States

Copperview Medical Center, South Jordan, Utah 84095, United States

Virgina Commonwealth, Richmond, Virginia 23219, United States

Childrens Hospital of the Kings Daughters, Norfolk, Virginia 23507, United States

A.S.T.H.M.A., Inc., Seattle, Washington 98105, United States

508 W 6th Av, Spokan, Washington 99204, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Novartis Study IA05 web site

Starting date: March 2004
Ending date: April 2008
Last updated: December 20, 2007