Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 23, 2006

Last Updated Date

June 3, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids [ Time Frame: 2005-2007 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids

Change History

Complete list of historical versions of study NCT00329381 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Evaluate the effect of omalizumab on the:
severity of first systemic allergic reaction to SIT
proportion of patients who were able to reach target maintenance SIT dose
number of visits required to complete cluster SIT dosing regimen
number of doses of rescue medications

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

Official Title ^ICMJE

A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab)on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids

Brief Summary

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Detailed Description

Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Xolair

Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Other Name: Omalizumab (Xolair)

Study Arms / Comparison Groups

1: Placebo Comparator
Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Intervention: Drug: Xolair
2: Experimental
Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Intervention: Drug: Xolair

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

Completion Date

October 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

clinical diagnosis and history of moderate persistent allergic asthma
body weight >/= 20kg and </= 150kg
Total serum IgE >/= 30 and </= 700IU/mL
on a stable asthma treatment including corticosteroids for the preceding 4 weeks
non smoker for at least 1 year prior to visit 1

Exclusion Criteria:

patients with severe asthma
history of immunotherapy to any allergen within the past 3 years
history of anaphylactic allergic reaction
upper respiratory tract infection

Gender

Both

Ages

18 Years to 55 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

NCT00329381

Responsible Party

Gailen D. Marshall, MD, PhD, University of Mississippi Medical Center

Study ID Numbers ^ICMJE

CiGE025AUS23

Study Sponsor ^ICMJE

University of Mississippi Medical Center

Collaborators ^ICMJE

Novartis

Investigators ^ICMJE

Principal Investigator:

Gailen D. Marshall, MD/PhD

University of Mississippi Medical Center

Information Provided By

University of Mississippi Medical Center

Verification Date

January 2007

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