Impact of Initiating Tiotropium Alone Versus Initiating Tiotropium in Combination With Fluticasone Propionate/Salmeterol Xinafoate Combination (FSC) on Chronic Obstructive Pulmonary Disease-related Outcomes in Patients With Pre-existing Exacerbations

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381406
First received: June 23, 2011
Last updated: September 15, 2011
Last verified: June 2011
  Purpose

This was a retrospective cohort design using administrative claims data from Jan 1, 2003 through Sep 30, 2007, representing the years of available data, were used for this study. Managed care enrollees having at least one pharmacy claim for tiotropium (TIO) during the study period were identified as the target population. An index TIO prescription was defined as the first chronologically occurring pharmacy claim for TIO during the period Jan 1, 2004 to Aug 31, 2006, called the enrollment period. The date of the index TIO prescription was termed as the index Rx date, and the 1-year period before the index Rx date was termed as the pre-index period. The period after the index date was termed as the post-index date, and is further divided into a 30-day combination assessment period and a 1-year follow-up period. COPD clinical and economic outcomes were measured in a variable length follow up period.

The combination assessment period, defined as the 30-day period following the index Rx date, was used to categorize patients into 2 cohorts: TIO alone or TIO + FSC (fluticasone propionate/salmeterol xinofoate combination) depending on whether they use FSC in combination with TIO during this period. Combination therapy with TIO + FSC was defined as having an FSC claim on the same date as the TIO claim or a TIO and FSC pharmacy claim with overlapping days supply occurring within 30 days of index Rx date. Enrollees adding FSC for the first time after the 30-day combination assessment period were excluded from the sample, thus ensuring that the TIO-alone cohort is not using FSC. No outcomes were assessed in the 30-day combination assessment period. The 1-year period after the end of the 30-day combination assessment period was termed as the follow-up period and was used to assess all study outcomes. Enrollees were required to be continuously eligible in their health plans during the pre-index and post-index periods for a total of 25 months. An intent-to-treat approach was used for the analyses. Thus, patients identified to be in a drug therapy cohort were considered to be using that therapy during the entire follow-up period, regardless of therapy discontinuations.

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

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


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Drug: TIO
Drug: TIO+FSC

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Initiating Tiotropium Alone Versus Initiating Tiotropium in Combination With Fluticasone Propionate/Salmeterol Xinafoate Combination (FSC) on Chronic Obstructive Pulmonary Disease-related Outcomes in Patients With Pre-existing Exacerbations

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) [ Time Frame: Data were collected over a maximum period of 4 years ] [ Designated as safety issue: No ]
    A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.


Secondary Outcome Measures:
  • Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group [ Time Frame: Data were collected over a maximum period of 4 years ] [ Designated as safety issue: No ]
    The mean costs of health care encounters adjusted to control for baseline differences between treatment groups and reported in 2008 United States dollars as calculated with the consumer price index (CPI) are presented. CPI is standard multiplier for adjusting the cost of goods and services to a single year. Total costs include pharmacy and medical costs. Medical costs were computed from the paid amounts of medical claims with a primary diagnosis code for COPD. COPD-related pharmacy costs were computed from paid amounts of COPD-related prescription medications.

  • Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years [ Time Frame: Data were collected over a maximum period of 4 years ] [ Designated as safety issue: No ]
    Unadjusted incidence rates per 100 person years of chronic obstructive pulmonary disease (COPD)-related hospitalizations and emergency department visits by treatment group are presented. Incidence rate is calculated by dividing the number of healthcare service encounters by the number of person years of follow up. Person years adjust for different lengths of follow up for individual participants


Enrollment: 3333
Study Start Date: July 2008
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD patients
Patients who are at least 40 years of age and diagnosed with COPD using ICD-9 codes of 491.xx, 492.xx, and 496.xx in an administrative claims database.
Drug: TIO
Patients receiving tiotropium bromide at index within the study period.
Other Name: Spiriva®
Drug: TIO+FSC
Patients receiving tiotropium bromide plus fluticasone propionate-salmeterol xinafoate combination at time of index within the study period.
Other Name: Spiriva ® + ADVAIR ®

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

Data for managed-care enrollees age 40 and older with a diagnosis of COPD and an index event of at least one pharmacy claim for TIO during the study period (January 1, 2003 through April 30, 2008) were identified. Subjects were required to have ≥1 exacerbation in the pre-index period (defined as a COPD-related emergency room visit or hospitalization), ≥1 prescription claim for ipratropium or ipratropium/albuterol combination in the pre-index period, ≥2 prescriptions for TIO (including the index prescription) during the post-index period, no prescription for FSC during the pre-index period, and no exacerbation or hospital/emergency room visit within 30 days after the index date. ICD-9-CM code 490.xx, bronchitis not specified as chronic or acute, was included in an attempt to enhance the validity of the analysis by capturing patients with chronic bronchitis whose condition was coded incorrectly.

Criteria

Inclusion Criteria:

  • Continuous health plan eligibility in the pre- and post-index periods
  • age ≥40 years at the index date
  • Presence of at least 1 claim with an ICD-9-CM code for COPD in any diagnosis field (490.xx, 491.xx, 492.xx, 496.xx) in the pre- and post-index period
  • ≥1 exacerbation in the pre-index period (defined as a COPD-related Emergency Room visit or hospitalization)
  • ≥1 prescription claim for ipratropium or ipratropium/albuterol combination in the pre-index period
  • an index event of at least one pharmacy claim for TIO (tiotropium) combination in the pre-index period during the study period (January 1, 2003 through April 30, 2008)
  • ≥2 prescriptions for TIO (including the index prescription) during the post-index period

Exclusion Criteria:

  • presence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis [TB], and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, sarcoidosis) during the pre- and post-index periods
  • use of FSC in pre-index period
  • exacerbation (emergency room visit or hospitalization) within 30 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: NCT01381406

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: NCT01381406     History of Changes
Other Study ID Numbers: 111266
Study First Received: June 23, 2011
Results First Received: September 15, 2011
Last Updated: September 15, 2011
Health Authority: United States: No Health Authority

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

ClinicalTrials.gov processed this record on September 30, 2014