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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639691
First Posted: March 20, 2008
Last Update Posted: September 29, 2016
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.
Information provided by (Responsible Party):
Novartis
  Purpose
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
Asthma Biological: omalizumab Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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
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  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00639691


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00639691     History of Changes
Other Study ID Numbers: CIGE025ACA01
First Submitted: March 13, 2008
First Posted: March 20, 2008
Last Update Posted: September 29, 2016
Last Verified: September 2016

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

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