Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00482508
First received: June 4, 2007
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice


Condition Intervention Phase
Asthma
Drug: Omalizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A One Year Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Poorly Controlled Moderate to Severe Allergic Asthma Patients Who Participated in the 52-week CIGE24IA04E1 Study

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety assessed by adverse events, serious adverse events, vital signs and laboratory safety data. A blood sample will be collected at each scheduled visit prior to administration of study medication and analyzed for free and total IgE levels and total

Enrollment: 95
Study Start Date: May 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patients who completed core study and extension study CIGE24IA05E1 up to and including visit 15, without experiencing any significant drug-related adverse events
  • Patients who have given written informed consent

Exclusion Criteria:

  • Patients who had not received study medication for greater than 84 days since visit 15 of study CIGE24IA05E1
  • 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.

  Contacts and Locations
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: NCT00482508

Sponsors and Collaborators
Novartis
Genentech, Inc.
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00482508     History of Changes
Other Study ID Numbers: CIGE025IA04E2
Study First Received: June 4, 2007
Last Updated: October 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: French Health Products Safety Agency (Afssaps)
Spain: Spanish Drug Agency
Switzerland: Swiss Medic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Asthma
anti immunoglobulin E
omalizumab

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014