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

Show 56 Study Locations

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 27, 2009