Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.

Novartis

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219323

CIGE025A1307

Details and patient eligibility

About

This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Enrollment: 133 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Allergic asthma patients
• Inadequately controlled patients

Exclusion criteria

• • History of severe anaphylactoid or anaphylactic reactions
• Previous treatment with omalizumab
• History of cancer or cancer

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)