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):
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.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||6 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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
|Novartis Investigative Site
|Montreal, Quebec, Canada |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 13, 2008
||May 23, 2012
||Canada: Health Canada
Keywords provided by Novartis:
Asthma, Anti-immunoglobin E, omalizumab
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 01, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Respiratory System Agents