Clinical Trial: Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Trial to Explore the Effects of 78 Weeks Omalizumab Treatment Given as Add on Therapy on Markers of Airway Inflammation and

Brief Summary: This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment) [ Time Frame: Baseline, at end of week 78 ]

The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.


Original Primary Outcome: The number of sub-epithelial eosinophils following 78 weeks treatment, as assessed biopsy samples

Current Secondary Outcome:

  • Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples [ Time Frame: Baseline, at end of week 78 ]
    The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
  • Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples [ Time Frame: Baseline, at end of week 78 ]
    The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
  • Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples [ Time Frame: Baseline, at end of week 78 ]
    The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
  • Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy [ Time Frame: 78 weeks ]


Original Secondary Outcome:

  • The number of sub-epithelial mast cells following 78 weeks treatment, as assessed biopsy samples
  • The number of sub-epithelial CD4+ T-lymphocytes following 78 weeks treatment, as assessed biopsy samples
  • The thickness of the lamina reticularis following 78 weeks treatment, as assessed in biopsy samples
  • The safety and tolerability of 78 weeks therapy


Information By: Novartis

Dates:
Date Received: April 30, 2008
Date Started: April 2008
Date Completion:
Last Updated: December 12, 2012
Last Verified: November 2012