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

November 23, 2021 updated by: Novartis Pharmaceuticals

Analyze the Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations Among Patients With Uncontrolled Asthma Receiving High Dose Inhaled Corticosteroids

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with uncontrolled asthma and using high-dose ICS prior to initiating omalizumab.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Omalizumab Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of emergency-department visits and hospitalizations
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2011

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (Estimate)

October 27, 2011

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEORUS0091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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