Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01331694 | Completed Results

• 1 other identifier: 112646
• Study Type: observational
• Target: 76,130
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate COPD-related clinical outcomes and total healthcare utilization in commercially insured (at least 40 years with a subanalysis of those aged 65 years and older) COPD population associated with the use of fluticasone/salmeterol combination (FSC) 250/50mcg compared to other initial maintenance therapies (IMTs), specifically, tiotropium bromide (TIO), and either ipratropium bromide or ipratropium bromide/albuterol (IP). This is a hypothesis testing study Ho: There is no difference in time to first COPD-related events between FSC and TIO and FSC and IP Ha: There is a difference in time to first COPD-related events between FSC and TIO and FSC and IP 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 TIO and FSC and IP Ha: There is a difference in COPD-related costs between FSC and TIO and FSC and IP

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Time to First Chronic Obstructive Pulmonary Disease (COPD) Event

  The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days.

  Anytime from 30 days to 12 months after initial treatment arm prescription

Secondary Outcomes (1)

• Average Annual Adjusted Post-Index COPD-Related Costs

  Incurred over the 12 month period after initial treatment arm prescription

Study Arms (1)

COPD

copd patients 65 years and older

Drug: fluticasone/salmeterol combination (FSC) 250/50mcg; Drug: tiotropium; Drug: ipratropium bromide alone or in fixed dose combination with albuterol

Interventions

fluticasone/salmeterol combination (FSC) 250/50mcg DRUG

patients initiating treatment with fluticasone/salmeterol combination (FSC) 250/50mcg

Also known as: Advair (TM)

COPD

tiotropium DRUG

patients initiating treatment with tiotropium

Also known as: Spiriva (TM)

COPD

ipratropium bromide alone or in fixed dose combination with albuterol DRUG

patients initiating treatment with ipratropium/albuterol

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

COPD

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

All population i.e. U\>U40 years: Each initial maintenance treatment (IMT) cohort (FSC 250/50mcg dose only, IP, and TIO) includes patients aged 40 years and older with at least 9 months of continuous enrollment (6 months pre-index and at least three months post-index) with a primary or secondary diagnosis of COPD \[International Classification of Disease, 9th revision, Clinical Modification (ICD-9-CM) codes 491.xx, 492.xx or 496.xx\]. Patients are observed such that everyone provides minimum 6 months of pre index baseline data and minimum 3 months post index (risk analysis) and minimum 12 months post index for cost analysis. Patients must receive either a 30-day supply of FSC or IP or TIO as the initial IMT medication, indicating "intent to treat." Patients may not also have a prescription filled for the other IMT medication within 60 days of the index date, or for the combination therapy budesonide/ formoterol (BFC), an inhaled corticosteroid (ICS) or a long acting beta agonist (LABA).

You may qualify if:

• IMT Cohorts (subjects selected by order of criteria)
• claim for one of the study medications and must not receive another study medication within 60 days of the initial maintenance therapy, indicating "intent to treat."
• at least one COPD-related ED or one COPD-related hospitalization, or two COPD-related outpatient visits (OV) associated with primary or secondary diagnosis for COPD (ICD-9-CM code 491.xx, 492.xx or 496.xx), at any time during the observation period (July 1, 2005 through June 30, 2008) in the database.
• Aged 65+ years on the index date or aged 40 and over for the sub-analysis.
• Continuous enrollment in a health plan for at least 6 months prior (pre-index) to initiation of IMT and at least three months after the first initiation of IMT (post-index).
• at least one prescription claim in the pre-index and each year of the post-index period for which they have follow-up.

You may not qualify if:

• primary or secondary diagnosis of respiratory tract cancer (larynx, trachea, or pleura). (ICD-9-CM codes 161, 161.X, 162, 163, 163.X, 231, 231.X).
• In the pre-index period, no claims for any of the cohort IMT medications, nor for any other Advair or budesonide/formoterol fixed dose combination, FSC combination medications, and may only have respiratory medication pharmacy claims for drugs included in the pre-index severity of illness assessment (Methylxanthines, Leukotriene Modifiers/Inhibitors, Omalizumab and Mast Cell Stabilizers).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Dalal AA, Roberts MH, Petersen HV, Blanchette CM, Mapel DW. Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2010 Dec 31;6:13-22. doi: 10.2147/COPD.S15455.

  PMID: 21311689 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Fluticasone-Salmeterol Drug Combination; Tiotropium Bromide; Ipratropium; Albuterol; 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)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salmeterol Xinafoate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Belladonna Alkaloids; Solanaceous Alkaloids

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: April 8, 2011
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 2, 2017
• Results First Posted: April 8, 2011

Record last verified: 2011-08