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

Sponsor:	University of Mississippi Medical Center
Collaborator:	Novartis
Information provided by:	University of Mississippi Medical Center
ClinicalTrials.gov Identifier:	NCT00329381

Purpose

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	Intervention	Phase
Asthma	Drug: Xolair	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

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 University of Mississippi Medical Center:

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 [ Time Frame: 2005-2007 ] [ Designated as safety issue: Yes ]

Enrollment:	14
Study Start Date:	May 2006
Study Completion Date:	October 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: Xolair Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level. Other Name: Omalizumab (Xolair)
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 Name: Omalizumab (Xolair)

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329381

Locations

United States, Mississippi
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

More Information

No publications provided

Responsible Party:	Gailen D. Marshall, MD, PhD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:	NCT00329381 History of Changes
Other Study ID Numbers:	CiGE025AUS23
Study First Received:	May 23, 2006
Last Updated:	June 3, 2008
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:

Allergic
Asthma
Immunotherapy

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity

Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012