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):
ClinicalTrials.gov Identifier:
First received: March 13, 2008
Last updated: May 23, 2012
Last verified: May 2012
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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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
Genders Eligible for Study:   Both
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.
  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: NCT00639691

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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00639691     History of Changes
Other Study ID Numbers: CIGE025ACA01 
Study First Received: March 13, 2008
Last Updated: May 23, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2016