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Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Xolair

About this trial

This is an interventional treatment trial for Asthma focused on measuring Allergic, Asthma, Immunotherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

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

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

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00329381

First Posted

May 23, 2006

Last Updated

June 3, 2008

Sponsor

University of Mississippi Medical Center

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00329381

Brief Title

Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

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 Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Mississippi Medical Center

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Allergic, Asthma, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Xolair

Other Intervention Name(s)

Omalizumab (Xolair)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Xolair

Other Intervention Name(s)

Omalizumab (Xolair)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gailen D. Marshall, MD/PhD

Organizational Affiliation

University of Mississippi Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

12. IPD Sharing Statement

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Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

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