Overview

This trial is active, not recruiting.

Condition asthma
Sponsor Novartis Pharmaceuticals
Start date May 2011
Trial identifier NCT01460862, HEORUS0091

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm

Primary Outcomes

Measure
Frequency of emergency-department visits and hospitalizations
time frame: 12 months

Eligibility Criteria

Male or female participants at least 12 years old.

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.

Additional Information

Official title Analyze the Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations Among Patients With Uncontrolled Asthma Receiving High Dose Inhaled Corticosteroids
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Novartis.