Study of Omalizumab in Moderate to Severe Bronchial Asthma

Asthma Clinical Trial

Official title:

Study of Omalizumab in Moderate to Severe Bronchial Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232050
• Other study ID #: CIGE025A1304
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2005
• Last updated: October 24, 2011
• Start date: October 2002
• Est. completion date: May 2005

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Omalizumab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Daiichi Sankyo Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning peak expiratory flow (PEF) at baseline and end of treatment.
Secondary	Pulmonary function parameters measured by spirometer
Secondary	Frequency of rescue medication use
Secondary	Symptom score
Secondary	Activities of daily living score
Secondary	Nighttime sleep score