Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment

NCT01395875 | Completed

• 1 other identifier: 113901
• Study Type: observational
• Target: 2,849
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 \[IPR\]).

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• risk of any COPD-related exacerbation

  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

  January 1, 2003 to March 31, 2009 (up to 6 years)

Secondary Outcomes (3)

• Moderate COPD exacerbation

  January 1, 2003 to March 31, 2009 (up to 6 years)

• COPD-related hospitalization/ED

  January 1, 2003 to March 31, 2009 (up to 6 years)

• COPD-related Costs

  January 1, 2003 to March 31, 2009 (up to 6 years)

Study Arms (1)

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); Drug: Anticholinergics (AC)

Interventions

Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC) DRUG

COPD patients receiving fluticasone propionate/salmeterol xinafoate combination (FSC) 250/50mcg

Also known as: Advair (TM)

COPD patients with moderate exacerbations

Anticholinergics (AC) DRUG

COPD patients receiving anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium \[IPR\]).

Also known as: Spiriva (TM), Atrovent (TM), Combivent (TM)

COPD patients with moderate exacerbations

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

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

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 16, 2017

Record last verified: 2017-05