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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482508
• Other study ID #: CIGE025IA04E2
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2007
• Last updated: October 24, 2011
• Start date: May 2003
• Est. completion date: October 2005

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: French Health Products Safety Agency (Afssaps)Spain: Spanish Drug AgencySwitzerland: Swiss MedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Omalizumab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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