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Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00482248
First received: June 4, 2007
Last updated: October 24, 2011
Last verified: October 2011

June 4, 2007
October 24, 2011
June 2003
June 2006   (final data collection date for primary outcome measure)
Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.
Same as current
Complete list of historical versions of study NCT00482248 on ClinicalTrials.gov Archive Site
Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator's assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr
Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator’s assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr
Not Provided
Not Provided
 
Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma
An Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Adults and Adolescents With Severe Allergic Asthma Who Participated in the 52 Week CIGE250011E2 Study

This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
Drug: Omalizumab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events
  • Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee

Exclusion Criteria:

  • Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3
  • Pregnant females or nursing mothers
  • Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs

Other protocol-defined inclusion/exclusion criteria may apply

Both
12 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00482248
CIGE0250011E3
Not Provided
Not Provided
Novartis
Genentech, Inc.
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP