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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639691
• Other study ID #: CIGE025ACA01
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2008
• Last updated: September 28, 2016
• Start date: January 2005
• Est. completion date: December 2011

Study information

• Verified date: September 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• omalizumab
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Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events from first visit until end of study
Secondary	To evaluate reasons for premature discontinuation.
Secondary	All adverse events, duration of study participation.