Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381471
First received: June 23, 2011
Last updated: March 15, 2012
Last verified: February 2012

June 23, 2011
March 15, 2012
August 2009
May 2010   (final data collection date for primary outcome measure)
  • Mean Number of Pharmacy Claims by Participants During the Post-Index Period [ Time Frame: One Year ] [ Designated as safety issue: No ]
    The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.
  • Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period [ Time Frame: One Year ] [ Designated as safety issue: No ]
    The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured.
HOSPITALIZATION/ER VISIT [ Time Frame: July 1, 2004 to September 30, 2006 (up to 2 years) ] [ Designated as safety issue: No ]
HOSPITALIZATION/ER VISIT related to COPD as well as oral steroids/antibiotics treatment associated with adherence
Complete list of historical versions of study NCT01381471 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients 40 years of age or older with at least one pharmacy claim for FSC during the index date range (July 1, 2005 through June 30, 2006). An index date was designated as the date of the first pharmacy claim for FSC. Patients were also required to have 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 outcome period (referred to as the outcome period). Eligible patients were further required to have at least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9-CM 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.

Pulmonary Disease, Chronic Obstructive
Drug: fluticasone propionate/salmeterol xinafoate combination
fluticasone propionate/salmeterol xinafoate combination
Other Name: Advair (TM)
COPD
Patients with a diagnosis code of COPD
Intervention: Drug: fluticasone propionate/salmeterol xinafoate combination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11060
May 2010
May 2010   (final data collection date for primary outcome measure)

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).
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01381471
113865
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP