N/A
N=11,060
Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01381471 ↗Enrolled (actual)
11,060
Serious AEs
—
Results posted
Mar 2012
Primary outcome: Primary: Mean Number of Pharmacy Claims by Participants During the Post-Index Period — 2.960; 0.219; 5.491; 0.573 pharmacy claims
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- fluticasone propionate/salmeterol xinafoate combination (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Pharmacy Claims by Participants During the Post-Index Period |
2.960; 0.219; 5.491; 0.573; 1.545; 2.181 | — |
| PRIMARY Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period |
2.048; 0.145; 0.078 | — |
Summary
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01381471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.