Last updated: 11/07/2018 02:35:27
Step down of fluticasone propionate/salmeterol combination therapy in asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A Retrospective Study of Healthcare Utilization and Costs of Step-Down Therapy in Asthma Patients Receiving Fluticasone Propionate/Salmeterol Combination
Trial description: The purpose of this study was to compare asthma related outcomes, including emergency department visits and hospitalzations. A meta-analysis of published and un-published studies that meet apriori criteria on length of study and outcomes measured for comparative trials of ICS vs ICS/LABA combination in pediatrics and ICS/LABA vs ICS/montelukast
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Asthma related systemic emergency department visit, and hospitalizations
Timeframe: Outcomes assessed at least 90 days post index
Secondary outcomes:
adherence to inhaled corticosteroids
Timeframe: at least 90 days post index
Interventions:
Drug: Fluticasone propionate
Drug: Fluticasone propionate/salmeterol combination
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Delea TE, Hagiwara M, Stempel DA, Stanford RH. Adding salmeterol to fluticasone propionate or increasing the dose of fluticasone propionate in patients with asthma. [Allergy Asthma Proc]. 2010;31(3):211-218.
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
February 2008 to July 2009
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
12 - 64 Year
Accepts healthy volunteers
none
- Asthma subjects identified with at least 1 ICD-9 code for asthma and >= 2 Rx claims of fluticasone propionate/salmeterol combination 250/50 or 500/50, prior to stepping down to fluticasone propionate/salmeterol 100/50 or 250/50 or fluticasone propionate 110 or 220.
- Subjects with >= 1 ICD-9 code for COPD or use of anticholinergics
Inclusion and exclusion criteria
Inclusion criteria:
- Asthma subjects identified with at least 1 ICD-9 code for asthma and >= 2 Rx claims of fluticasone propionate/salmeterol combination 250/50 or 500/50, prior to stepping down to fluticasone propionate/salmeterol 100/50 or 250/50 or fluticasone propionate 110 or 220.
Exclusion criteria:
- Subjects with >= 1 ICD-9 code for COPD or use of anticholinergics
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2009-01-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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