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 )
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.
||Observational Model: Cohort
Time Perspective: Retrospective
||Analyze the Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations Among Patients With Uncontrolled Asthma Receiving High Dose Inhaled Corticosteroids
Primary Outcome Measures:
- Frequency of emergency-department visits and hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Study Start Date:
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with uncontrolled asthma and using high-dose ICS prior to initiating omalizumab.
- ≥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.
Other protocol-defined inclusion/exclusion criteria may apply.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01460862
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 25, 2011
||October 25, 2011
||United States: Food and Drug Administration
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 19, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Respiratory System Agents