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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
History of Changes
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
 Drug: fluticasone propionate/salmeterol xinafoate combination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Enrollment: 11060
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD
Patients with a diagnosis code of COPD
 Drug: fluticasone propionate/salmeterol xinafoate combination
fluticasone propionate/salmeterol xinafoate combination
Other Name: Advair (TM)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381471

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381471     History of Changes
Other Study ID Numbers: 113865
Study First Received: June 23, 2011
Results First Received: February 2, 2012
Last Updated: March 15, 2012
Health Authority: United States: No Health Authority

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 23, 2013