Skip to main content
OpenTrials
Completed

NCT Number: NCT00639691

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omalizumab

Biological

sc

Primary outcomes

  1. Serious Adverse Events from first visit until end of study

Secondary outcomes

  1. To evaluate reasons for premature discontinuation.

  2. All adverse events, duration of study participation.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Mar 20, 2008
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.