Study of Omalizumab 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

NCT00232050

CIGE025A1304

Details and patient eligibility

About

This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.

Enrollment: 327 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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind