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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Novartis.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 25, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted

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 ] [ Designated as safety issue: No ]

Study Start Date: May 2011
Omalizumab Cohort


Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01460862

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01460862     History of Changes
Other Study ID Numbers: HEORUS0091
Study First Received: October 25, 2011
Last Updated: October 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses processed this record on November 23, 2014