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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

June 3, 2008
June 5, 2008
May 2006
May 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00691873 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: Placebo
    placebo
  • 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)
  • 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.
    Intervention: Drug: Placebo
  • Experimental: 2
    Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
    Intervention: Drug: Xolair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00691873
Marshall, Gailen 6 3 08
Yes
Gailen D. Marshall, MD, PhD, University of Mississippi Medical Center
University of Mississippi Medical Center
Novartis
Principal Investigator: Gailen D. Marshall, MD/PhD University of Mississippi Medical Center
University of Mississippi Medical Center
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP