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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01460862
First received: October 25, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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.


Condition
Asthma

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
Groups/Cohorts
Omalizumab Cohort

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01460862

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov 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:
Asthma
Omalizumab

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2014