ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00691873
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2008
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Mississippi Medical Center

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 Type : Interventional  (Clinical Trial)
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 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab

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 Name: Omalizumab (Xolair)




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: January 2007

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
Anti-Asthmatic Agents
Respiratory System Agents