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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01337336
First received: April 15, 2011
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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).


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a Comorbid COPD-Depression/Anxiety Population

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation [ Time Frame: Maximum of 1 year after index date (January 1, 2004 to June 30, 2009) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With the Indicated COPD-related Exacerbations [ Time Frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) ] [ Designated as safety issue: No ]
    The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER 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.

  • Mean Annual COPD-related Costs Per Participant [ Time Frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) ] [ Designated as safety issue: No ]
    Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.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.

  • Number of the Indicated COPD-related Exacerbations [ Time Frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) ] [ Designated as safety issue: No ]
    The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. 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.


Enrollment: 1
Study Start Date: October 2010
Study Completion Date: March 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
combination fluticasone priopionate and salmeterol xinafoate 250/50mcg
Other Names:
  • FSC
  • Advair (TM)
Drug: Anticholinergics
tiotropium; ipratropium alone; or ipratropium + albuterol
Other Names:
  • tiotropium
  • ACs
  • ipratropium

Detailed Description:

This was a retrospective cohort study using a large administrative database (study period: 1/1/2003 through 6/30/2009). Date of first FSC or ACs (tiotropium; ipratropium alone or in combination with albuterol) was defined as the index date. Managed care enrollees (aged >40 years) having at least one medical claim with a primary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) and a diagnosis of depression (at least one claim with depression/anxiety or at least one prescription claim for depression/anxiety) in one-year pre-index and within 60-days post-index were defined in the comorbid population. Patients were continuously eligible throughout the one-year pre and post-index periods. Negative binomial models were used to analyze number of COPD-related events [hospitalization (IP), emergency department (ED), office visits with oral steroid and/or antibiotic prescription within 5 days (OV+Rx)] and logistic regression was used to examine risk of COPD events between the two cohorts. COPD-related costs were compared between the two cohorts using - generalized linear model with log-link/gamma distribution after adjusting for baseline differences.

Specifically the study hypothesis for the primary outcome being tested was:

Ho: There is no difference in risk of any COPD-related exacerbation between FSC and AC cohorts Ha: There is a difference in risk of any COPD-related exacerbation between FSC and AC cohorts

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 AC cohorts Ha: There is a difference in COPD-related costs between FSC and AC cohorts

  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

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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337336

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01337336     History of Changes
Other Study ID Numbers: 113902
Study First Received: April 15, 2011
Results First Received: April 21, 2011
Last Updated: June 16, 2011
Health Authority: United States: No Health Authority

Additional relevant MeSH terms:
Chronic Disease
Depression
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Albuterol
Cholinergic Antagonists
Fluticasone
Ipratropium
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014