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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 25, 2011
Last updated: March 25, 2016
Last verified: March 2016
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Frequency of emergency-department visits and hospitalizations [ Time Frame: 12 months ]

Study Start Date: May 2011
Omalizumab Cohort


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with uncontrolled asthma and using high-dose ICS prior to initiating omalizumab.

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01460862

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01460862     History of Changes
Other Study ID Numbers: HEORUS0091
Study First Received: October 25, 2011
Last Updated: March 25, 2016

Keywords provided by Novartis:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Disease Attributes
Pathologic Processes
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on April 26, 2017