Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations

Withdrawn

• Conditions: Asthma

• Registration Number: NCT01460862
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

A retrospective database analysis to evaluate the impact of omalizumab on the use of corticosteroid, emergency-department visits and hospitalizations among patients with uncontrolled asthma and using high-dose Inhaled Corticosteroids (ICS) prior to initiating omalizumab.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-27
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ≥12 years of age with a documented Cystic fibrosis (CF) diagnosis,
• on Long acting Beta antagonist- Inhaled Corticosteroid (LABA-ICS) at baseline,
• uncontrolled asthma at baseline.

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of emergency-department visits and hospitalizations	12 months