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

Tracking Information

First Received Date ^ICMJE

March 18, 2004

Last Updated Date

May 5, 2009

Start Date ^ICMJE

March 2004

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

the 52 week double-blind treatment period and 16 week follow-up period
on the clinically significant asthma exacerbation rate during the 24 week
The primary safety objective is to confirm the safety of omalizumab during
The primary efficacy objective is to demonstrate the effect of omalizumab
double-blind fixed steroid treatment

Change History

Complete list of historical versions of study NCT00079937 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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.

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).

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Omalizumab
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

570

Completion Date

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00079937

Responsible Party

external affairs, Novartis

Study ID Numbers ^ICMJE

CIGE025AIA05

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP