Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population

NCT01337336 | Completed Results

• 1 other identifier: 113902
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to examine COPD-related outcomes for patients with comorbid depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate compared to those receiving anticholinergics. The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary disease (COPD) is estimated to be high and range from 10-40%, given that the risk of depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD. Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related healthcare utilization and costs compared to those without depression/anxiety. Therapy with maintenance medications for COPD has been recommended to prevent future adverse COPD outcomes, but the impact of initiating these interventions has not yet been evaluated in a higher-risk population with comorbid COPD-depression/anxiety. The present study compares the risk of COPD exacerbations and COPD-related costs in patients initiating maintenance medications for treatment of COPD in a comorbid COPD/depression-anxiety population. Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively abbreviated as IPR).

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation

  The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.

  Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)

Secondary Outcomes (3)

• Number of Participants With the Indicated COPD-related Exacerbations

  Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)

• Mean Annual COPD-related Costs Per Participant

  Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)

• Number of the Indicated COPD-related Exacerbations

  Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)

Study Arms (1)

COPD patients with comorbid depression/anxiety

Patients aged 40 and over with COPD and comorbid depression/anxiety. Managed care enrolees (aged \>40 years) having newly initiated drug therapy with FSC or AC during the identification period (01/01/2004 to 06/30/2008) to treat COPD with a medical or pharmacy claim for depression before and 60 days post index date were the target population. The first fill date of FSC or AC was the index date.

Drug: fluticasone propionate/salmeterol xinafoate; Drug: Anticholinergics

Interventions

fluticasone propionate/salmeterol xinafoate DRUG

combination fluticasone priopionate and salmeterol xinafoate 250/50mcg

Also known as: FSC, Advair (TM)

COPD patients with comorbid depression/anxiety

Anticholinergics DRUG

tiotropium; ipratropium alone; or ipratropium + albuterol

Also known as: tiotropium, ACs, ipratropium

COPD patients with comorbid depression/anxiety

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

The study population included patients with both COPD and depression/anxiety. They were identified as follows: Patients who had at least one pharmacy claim for a maintenance medication used to treat COPD were identified. Of these, patients were considered to have comorbid depression/anxiety if they had at least one prescription claim for a medication used to treat depression/anxiety and a diagnosis code for depression/anxiety during 1 year pre-index or within 60 days after the index date.

You may qualify if:

• Diagnosis of COPD in any field in the pre-index period and 60 days after the index date
• Diagnosis of depression/anxiety in any field and a medication for treating depression/anxiety in the pre-index period and 60 days after the index date
• Index date occurs during identification period
• Patients must be continuously eligible during 1-year pre and 1-year post-index date and be of at least 40 years of age

You may not qualify if:

• comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis) during the 1 year pre or post-index periods
• No other maintenance medications other than the index medication on or 60 days after the index date

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone-Salmeterol Drug Combination; Cholinergic Antagonists; Tiotropium Bromide; Ipratropium

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)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; 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: April 15, 2011
• First Posted: April 18, 2011
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2011
• Last Updated: May 30, 2017
• Results First Posted: May 20, 2011

Record last verified: 2017-05