Last updated: 11/03/2018 15:44:42

Fluticasone propionate-salmeterol combination adherence in Patients with Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
113865
See study documents
Clinicaltrials.gov ID
NCT01381471
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Fluticasone propionate-salmeterol combination adherence in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean Number of Pharmacy Claims by Participants during the Post-Index Period

Timeframe: One Year

Mean Number of Healthcare Encounters Incurred by Participants during the Post-Index Period

Timeframe: One Year

Secondary outcomes:
Not applicable
Interventions:
Drug: fluticasone propionate/salmeterol xinafoate combination
Enrollment:
11060
Observational study model:
Cohort
Primary completion date:
2010-01-01
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
August 2009 to January 2010
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • INCLUSION CRITERIA
  • at least one pharmacy claim for Advair (any strength; Diskus or MDI) during the index year (July 1, 2005 through June 30, 2006).
Inclusion and exclusion criteria
Inclusion criteria:
  • INCLUSION CRITERIA
  • at least one pharmacy claim for Advair (any strength; Diskus or MDI) during the index year (July 1, 2005 through June 30, 2006).
  • Continuous medical and pharmacy eligibility for the 12 month Pre-Index year and the 12 month Index year (referred to as the 24 month Observation Period), and the 3 month Post-Index period (referred to as the Outcome Period).
  • At least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9 code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an Anticholinergic medication, both occurring during the12 month pre-index period.
  • At least 40 years old at index date. EXCLUSION CRITERIA
  • any medical claim (ever) with a primary or secondary diagnosis of cystic fibrosis (ICD-9 code 277.0x).

Trial location(s)

No location data available.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2010-01-01
Actual study completion date
2010-01-01

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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