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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00691873
First received: June 3, 2008
Last updated: June 5, 2008
Last verified: January 2007
  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: Placebo
Drug: Xolair
Phase 4

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:


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: 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691873

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: NCT00691873     History of Changes
Other Study ID Numbers: Marshall, Gailen 6 3 08
Study First Received: June 3, 2008
Last Updated: June 5, 2008
Health Authority: 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 September 18, 2014