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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01460862
Other study ID # HEORUS0091
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date May 2011
Est. completion date May 2011

Study information

Verified date November 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of emergency-department visits and hospitalizations 12 months
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