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

NCT ID: NCT01381471

Last Updated: 2012-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11060 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD

Patients with a diagnosis code of COPD

fluticasone propionate/salmeterol xinafoate combination

Intervention Type DRUG

fluticasone propionate/salmeterol xinafoate combination

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fluticasone propionate/salmeterol xinafoate combination

fluticasone propionate/salmeterol xinafoate combination

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Advair (TM)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

113865

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Modification Of Disease Outcome In COPD
NCT00158847 TERMINATED PHASE4