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

June 23, 2011
September 15, 2011
July 2008
June 2010   (final data collection date for primary outcome measure)
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.
Any COPD Exacerbation [ Time Frame: Jan 1, 2003 to Sep 30, 2007 (upto 4 years) ] [ Designated as safety issue: No ]
COPD related hospitalization, emergency department visit, outpatient visit as defined by ICD-9 codes (491.xx, 492.xx, 496.xx) in the primary position. This is estimated as risk reduction using cox proportional hazards regression.
Complete list of historical versions of study NCT01381406 on ClinicalTrials.gov Archive Site
  • 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
  • COPD Costs [ Time Frame: Jan 1, 2003 to Sep 30, 2007 (upto 4 years) ] [ Designated as safety issue: No ]
    COPD related medical pharmacy and total costs
  • COPD hospitalization/ER visit combined endpoint [ Time Frame: Jan 1, 2003 to Sep 30, 2007 (upto 4 years) ] [ Designated as safety issue: No ]
    COPD related hospitalization or emergency department visit as a combined endpoint as defined by ICD-9 codes (491.xx, 492.xx, 496.xx) in the primary position. This is estimated as risk reduction using cox proportional hazards regression.
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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
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 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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample

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.

Pulmonary Disease, Chronic Obstructive
  • 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 ®
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.
Interventions:
  • Drug: TIO
  • Drug: TIO+FSC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3333
September 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01381406
111266
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP