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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01460862
Collaborator
(none)
0
Enrollment

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    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
    Anticipated Study Start Date :
    May 1, 2011
    Anticipated Primary Completion Date :
    May 1, 2011
    Anticipated Study Completion Date :
    May 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Omalizumab Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of emergency-department visits and hospitalizations [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01460862
    Other Study ID Numbers:
    • HEORUS0091
    First Posted:
    Oct 27, 2011
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Novartis Pharmaceuticals
    Asthma
    Omalizumab
    Additional relevant MeSH terms:
    Asthma
    Emergencies

    Study Results

    No Results Posted as of Dec 7, 2021