Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

Sponsor

University of Mississippi Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00691873

Collaborator

Novartis (Industry)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Placebo Drug: Xolair	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.	Drug: Placebo placebo
Experimental: 2 Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.	Drug: Xolair Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level. Other Names: Omalizumab (Xolair)

Arm

Intervention/Treatment

Placebo Comparator: 1

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

Drug: Placebo

placebo

Experimental: 2

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

Drug: Xolair

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

Other Names:

Omalizumab (Xolair)

Outcome Measures

Primary Outcome Measures

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 [2005-2007]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216

Sponsors and Collaborators

University of Mississippi Medical Center
Novartis

Investigators

Principal Investigator: Gailen D. Marshall, MD/PhD, University of Mississippi Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00691873

Other Study ID Numbers:

Marshall, Gailen 6 3 08

First Posted:

Jun 6, 2008

Last Update Posted:

Jun 6, 2008

Last Verified:

Jan 1, 2007

Keywords provided by , ,

Allergic

Asthma

Immunotherapy

Additional relevant MeSH terms:

Asthma

Omalizumab

Study Results

No Results Posted as of Jun 6, 2008