Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01395875
First received: July 14, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all diagnosed COPD patients. Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs. The objective of the following study was to conduct an analysis in the real-world setting to (1) identify and characterize COPD patients with moderate exacerbations and (2) evaluate the impact of initiating different maintenance therapies in this population. Maintenance therapy medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Drug: Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)
Drug: Anticholinergics (AC)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • risk of any COPD-related exacerbation [ Time Frame: January 1, 2003 to March 31, 2009 (up to 6 years) ] [ Designated as safety issue: No ]
    risk of the following types of COPD-related exacerbations between patients receiving FSC vs AC: COPD-related physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx) and/or COPD-related hospitalization or an ED visit


Secondary Outcome Measures:
  • Moderate COPD exacerbation [ Time Frame: January 1, 2003 to March 31, 2009 (up to 6 years) ] [ Designated as safety issue: No ]
    Risk of COPD-related exacerbations for patients with physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx).

  • COPD-related hospitalization/ED [ Time Frame: January 1, 2003 to March 31, 2009 (up to 6 years) ] [ Designated as safety issue: No ]
    Risk of COPD-related exacerbations for patients with COPD hospitalization with primary diagnosis code for COPD and ED visits with the same.

  • COPD-related Costs [ Time Frame: January 1, 2003 to March 31, 2009 (up to 6 years) ] [ Designated as safety issue: No ]
    Comparing average monthly COPD-related costs and cost components between patients receiving FSC vs AC. Medical, pharmacy and total costs were examined


Enrollment: 2849
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD patients with moderate exacerbations
COPD patients with COPD-related using ICD-9 codes physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx)
Drug: Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)
COPD patients receiving fluticasone propionate/salmeterol xinafoate combination (FSC) 250/50mcg
Other Name: Advair (TM)
Drug: Anticholinergics (AC)
COPD patients receiving anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).
Other Names:
  • Spiriva (TM)
  • Atrovent (TM)
  • Combivent (TM)

Detailed Description:

Data from January 1, 2003 to March 31, 2009 will be available and termed as the study period. Patients with at least one moderate exacerbation defined as a physician/outpatient visit with a primary diagnosis of COPD and having an oral corticosteroid (OCS) or antibiotic prescription (ABX) within 5 days of physician/outpatient visit will be identified as the target population. The date of the first moderate exacerbation will serve as the patient's index date, and will be identified during the identification period of January 1, 2004 through February 28, 2009. Furthermore this moderate exacerbation should be the first medical claim with a primary diagnosis of COPD to ensure that only patients with moderate exacerbations will be captured. Subsequently, patients will be categorized into study cohorts based on the first maintenance drug prescription (index drug) received during the 30-day period after the index date termed as the treatment assessment period. Maintenance drugs considered include fluticasone-salmeterol 250/50 mcg (FSC) or anticholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]). Patients not receiving any maintenance medication or those receiving maintenance medications other than those considered during the treatment assessment period will be excluded.

All outcomes will be assessed during a follow-up period that will vary in length between 1 day and 1 year for each patient. The variable follow-up period will be defined as the period that starts on the day after the treatment assessment period, and ends on the earliest of the following event dates: the end of the study period (March 31, 2009), the end of the patient's continuous eligibility in the health plan, the end of the patient's 1-year follow-up, treatment switch date (ie, a switch to any study medication different from the index drug), discontinuation date of the index drug (ie, more than a 60-day gap between the end of the days' supply of the preceding prescription and the fill date of the next consecutive prescription), or occurrence of any COPD-related exacerbation (COPD-related hospitalization, ED visit, or physician/outpatient visit with a prescription for an oral corticosteroid or antibiotic within 5 days of the visit).

A 1-year period before the index date (pre-period) will be used to provide a baseline assessment of the study cohorts. The specific dates for the pre- and follow-up periods will vary for each patient depending on their index date.

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

Data from January 1, 2003 to March 31, 2009 will be available and termed as the study period. Patients with at least one moderate exacerbation defined as a physician/outpatient visit with a primary diagnosis of COPD (ICD-9 diagnosis codes) and having an oral corticosteroid (OCS) or antibiotic (ABX) prescription within 5 days of physician/outpatient visit will be identified as the target population. The date of this first moderate exacerbation will serve as the patient's index date, and will be identified during an identification period of January 1, 2004 to March 31, 2008 allowing for a maximum of a 1-year period before (pre-period) and after the index date (follow-up). The specific dates for the pre- and follow-up periods will be different for each patient depending on their index date. Furthermore this index moderate exacerbation should be the first medical claim with a primary diagnosis of COPD to ensure that only patients with moderate exacerbations will be captured.

Criteria

Inclusion Criteria:

  • minimum age 40 years at index
  • continuously enrolled in health plan
  • diagnosis of COPD (ICD-9 codes of 491, 492, 496)
  • at least one moderate exacerbation event as defined previously.

Exclusion Criteria

  • Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis
  • Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation
  • Receipt of maintenance medication in the pre-period
  • Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395875

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01395875     History of Changes
Other Study ID Numbers: 113901
Study First Received: July 14, 2011
Last Updated: July 14, 2011
Health Authority: United States: No Health Authority

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

ClinicalTrials.gov processed this record on April 23, 2014