Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies

NCT01332461 | Completed Results

• 1 other identifier: 112609
• Study Type: observational
• Target: 5,677
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a retrospective cross-sectional database study using administrative data (study period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged \>40 years) having at least one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index event) during the study period was the target population. All subjects were required to have one year of pre-index period baseline data. COPD events of interest were ER, Hospital and physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days. Other censoring events were treatment switch; loss of enrollment; \>60-day gap between medication fills; or end of study period. This study is a non descriptive hypothesis testing study. Key study hypotheses are listed below. Specifically the study hypotheses for the primary outcome being tested were: Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha: There is a difference in risk of COPD-related hospitalization between FSC and OMT Hypothesis for the key secondary outcome of COPD-related costs that was tested was: Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a difference in COPD-related costs between FSC and OMT

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years

  The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.

  Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)

Secondary Outcomes (2)

• Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years

  Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)

• Mean Monthly COPD-related Costs Per Participant

  Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)

Study Arms (1)

COPD Patients

Patients over the age of 40 with a COPD-related hospital or ER visit

Drug: fluticasone propionate/salmeterol xinafoate combination; Drug: Other maintenance Treatments (OMT)

Interventions

fluticasone propionate/salmeterol xinafoate combination DRUG

Patients filling a prescription for fluticasone/salmeterol combination as index drug

Also known as: Advair (TM)

COPD Patients

Other maintenance Treatments (OMT) DRUG

OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists

Also known as: Spiriva (TM), Atrovent (TM), Combivent (TM), Serevent (TM), Foradil (TM)

COPD Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Managed care enrollees (aged \>40 years) having at least one IP with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one ER visit with primary diagnosis of COPD (index event) during the study period was the target population

You may qualify if:

• At least one hospitalization with a primary or secondary diagnosis of COPD or at least one ER visit with a primary diagnosis of COPD
• Initiatiation (prescription) of FSC or non-FSC (i.e. TIO, ICS, LABA, IPR) during peri-index period
• At least 40 years of age
• Continuous eligibility in the pre-index, peri-index, and follow-up periods

You may not qualify if:

• Controller medication use during peri-index period
• COPD-related hospitalization, ER visit, or physician visit plus OCS/Abx within 3 days of visit during the peri-index period

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Dalal AA, Shah M, D'Souza AO, Mapel DW. COPD-related healthcare utilization and costs after discharge from a hospitalization or emergency department visit on a regimen of fluticasone propionate-salmeterol combination versus other maintenance therapies. Am J Manag Care. 2011 Mar 1;17(3):e55-65.

  PMID: 21504260 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone-Salmeterol Drug Combination; Tiotropium Bromide; Ipratropium; Albuterol, Ipratropium Drug Combination; Salmeterol Xinafoate; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Belladonna Alkaloids; Solanaceous Alkaloids

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: April 11, 2011
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 27, 2017
• Results First Posted: April 11, 2011

Record last verified: 2017-06