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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00079937

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Omalizumab Drug: placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To confirm the safety of omalizumab during the 52 week double-blind treatment period and 16 week follow-up period [ Time Frame: 52 weeks plus 16 weeks follow-up ] [ Designated as safety issue: Yes ]
To demonstrate the effect of omalizumab on the clinically significant asthma exacerbation rate during the 24 week double-blind fixed steroid treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in nocturnal clinical symptom score (24 week double-blind fixed steroid treatment period) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Clinically significant asthma exacerbation rate (52 week double-blind treatment period) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Change in beta2-agonist rescue medication use (24 week double-blind fixed steroid treatment period) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in quality of life (24 week double-blind fixed steroid treatment period) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	570
Study Start Date:	March 2004
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Omalizumab
2: Placebo Comparator	Drug: placebo

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).

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079937

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Locations

United States, Alabama
Alabama Allergy and Asthma Center
Birmingham, Alabama, United States, 35209
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
Clinical Research Center
Little Rock, Arkansas, United States, 72205
United States, California
Allergy and Asthma Associates of Santa Clara Valley RC
San Jose, California, United States, 95117
Allergy and Asthma Medical Group & Research Center
San Diego, California, United States, 92123
Allergy Associates Medical Group
San Diego, California, United States, 92120
Pediatric Care and Medical Group
Huntington Beach, California, United States, 92647
CA Allergy & Asthma Med Group
Palmdale, California, United States, 93551
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, United States, 92647
Integrated Research Group
Riverside, California, United States, 92506
Dr. Joann Blessing-Moore
Palo Alto, California, United States, 94304
Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology
Orange, California, United States, 92868
West Coast Clinical Trials
Long Beach, California, United States, 90806
Allergy & Asthma Med Group of Diablo Valley CR
Walnut Creek, California, United States, 94598
Southern California Research Center
Mission Viejo, California, United States, 92691
Bensch Research Associates
Stockton, California, United States, 95207
1304 15th St
Santa Monica, California, United States, 90404
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, Georgia
Family Allergy and Asthma Center, PC
Atlanta, Georgia, United States, 30342
Georgia Pollens
Albany, Georgia, United States, 31707
Aeroallergy Research Labs of Savannah, Inc
Savannah, Georgia, United States, 31406
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Asthma & Allergy Center
Elliott City, Maryland, United States, 21042
United States, Massachusetts
Northeast Med Research Associates
North Dartmouth, Massachusetts, United States, 02747
United States, Missouri
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63104
United States, Nebraska
Midwest Allergy & Asthma Clinic
Omaha, Nebraska, United States, 68114
United States, New Jersey
Ocean Allergy & Respiratory Research Center
Brick, New Jersey, United States, 08724
UMDNJ
Newark, New Jersey, United States, 07101
United States, New York
Island Medical Research (Allergy and Asthma Center)
Rockville Center, New York, United States, 11570
Womes And childrens Hospital of Buffalo
Buffalo, New York, United States, 14222
Asthma & Allergy Associates
Ithaca, New York, United States, 14850
Allergy and Asthma Diagnostic Office
Liverpool, New York, United States, 13088
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Allergy & Asthma Center of North carolina
High Point, North Carolina, United States, 27262
United States, Ohio
Bernstein Clinical Research Center
Cincinnati, Ohio, United States, 45231
United States, Oklahoma
Resp Dis of Children and Adolescents
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Clinical Research Institute of Southern Oregon
medford, Oregon, United States, 97504
United States, Pennsylvania
West Penn Allegheny General Health System
Pittsburgh, Pennsylvania, United States, 15212
Asthma and Allergy Associates
Upland, Pennsylvania, United States, 19013
501 Howard Av
Altoona, Pennsylvania, United States, 16601
United States, Rhode Island
AAPRI Clinical Research Institute
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Allergy Assoc., The ASthma, Allergy & Sinus Ctr
Knoxville, Tennessee, United States, 37922
United States, Texas
North Texas Institute for Clinical Trials
Ft. Worth, Texas, United States, 76132
Pediatric Allergy/Immunology Associates, PA
Dallas, Texas, United States, 75230
Pediatric Pulmonary Association of North Texas
Dallas, Texas, United States, 75230
Baylor College of Medicine
Houston, Texas, United States, 77030
Sylvanna Research
San Antonio, Texas, United States, 78229
7707 Fannin/Ste. 195
Houston, Texas, United States, 77054
United States, Utah
Copperview Medical Center
South Jordan, Utah, United States, 84095
United States, Virginia
Virgina Commonwealth
Richmond, Virginia, United States, 23219
Childrens Hospital of the Kings Daughters
Norfolk, Virginia, United States, 23507
United States, Washington
A.S.T.H.M.A., Inc.
Seattle, Washington, United States, 98105
508 W 6th Av
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Novartis Study IA05 web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( external affairs )
Study ID Numbers:	CIGE025AIA05
Study First Received:	March 18, 2004
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00079937 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

allergic
asthma
atopic
omalizumab

immunoglobulin E
IgE
anti-IgE

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab

ClinicalTrials.gov processed this record on November 25, 2009