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A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: March 13, 2008
Last updated: September 28, 2016
Last verified: September 2016
This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to GINA step 4 treatment guidelines.

Condition Intervention Phase
Biological: omalizumab
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab)in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Serious Adverse Events from first visit until end of study

Secondary Outcome Measures:
  • To evaluate reasons for premature discontinuation.
  • All adverse events, duration of study participation.

Enrollment: 48
Study Start Date: January 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: omalizumab


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or female, ≥ 6years of age;
  • who have a diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria;
  • severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per Canadian Asthma Consensus Report (1999));
  • Subjects having successfully completed one of the following protocols: CIGE025A011E3, CIGE025A2425, CIGE025AIA05;
  • elevated immunoglobin E levels

Exclusion Criteria:

  • significant systemic disease
  • pregnancy or lactation
  • an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
  • history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
  • current treatment with warfarin (Coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.
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Please refer to this study by its identifier: NCT00639691

Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada
Sponsors and Collaborators
  More Information

Responsible Party: Novartis Identifier: NCT00639691     History of Changes
Other Study ID Numbers: CIGE025ACA01
Study First Received: March 13, 2008
Last Updated: September 28, 2016

Keywords provided by Novartis:
Asthma, Anti-immunoglobin E, omalizumab

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on April 28, 2017