Pulmonary Disease, Chronic ObstructiveNCT01387178

Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: fluticasone propionate/salmeterol 250µg/50µg (FSC) and tiotropium bromide (TIO)
How many people: 22,223 participants
Where: No sites listed yet
Study dates: Jul 2008to Feb 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patient records for commercially-insured patients with chronic obstructive pulmonary disease (COPD) aged 40 and older. For the risk-analysis population, patients were required to have at least 12 months of continuous enrollment prior to the index date and at least 3 months of continuous enrollment after the index date. A subgroup analysis was conducted for costs that included patients in the total population who also had at least 12 months of continuous coverage following the index date (the cost-analysis population).

Who may be able to join

Patient is age 40 or older
Patient record indicates a new prescription claim for fluticasone propionate/salmeterol (FSC) or tiotropium bromide (TIO) (first pharmacy claim defines the index date)
Patient records include at least two medical claims with a primary or non-primary diagnosis of COPD (International Classification of Disease-9 [ICD-9] code 490.xx - 492.xx or 496.xx)
At least one of the patient's ICD-9 codes for COPD is observed in the 12 months prior to the first pharmacy claim for FSC or TIO (the index date)

Who cannot join

A pharmacy claim for FSC or TIO prior to the index date
The patient initiated FSC at a dose other than 250µg/50µg
The patient initiated FSC and TIO at the same time
The patient had one or more prescription with missing dosing information
The patient had a prescription claim for the study medication other than the one they started on at the index date within 60 days after the index date

About this study

Chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation caused by inflammation-mediated damage to lung tissue. Although damage to lung tissue in COPD appears to be irreversible, evidence suggests that the course of COPD can be altered through measures such as smoking cessation, pulmonary rehabilitation, and the use of pharmacotherapy for bronchodilation. A primary goal of maintenance pharmacotherapy is to reduce the incidence of acute exacerbations and the associated hospitalizations and emergency department (ED) visits. Bronchodilation in COPD maintenance therapy can be accomplished with the long-acting anticholinergic tiotropium (TIO), long acting beta-agonists (e.g. formoterol, salmeterol), methylxanthines (e.g. theophylline), or combination therapy with a long-acting beta-agonist and an inhaled corticosteroid (e.g. fluticasone propionate/salmeterol [FSC]).

The objective of this study is to compare the benefits of combination long-acting beta-agonist/inhaled corticosteroid therapy to long-acting anticholinergic therapy. The study compares the risk of COPD exacerbations and COPD-related healthcare utilization and costs for commercially-insured patients age 40 and older who were prescribed FSC to those prescribed TIO. The null hypothesis is that no difference exists between the costs and outcomes of COPD patients treated with TIO and those treated with FSC. The test hypothesis is that patients treated with either TIO or FSC will incur lower costs and use fewer healthcare resources for the management of COPD.

The source of data for this study was the Ingenix Impact database (formerly the Integrated Healthcare Information Services [IHCIS] database). This is an administrative claims database that includes patient-level data on enrollment, facility, professional, and pharmacy services from approximately 50 million patients covered by more than 40 managed care health plans across the United States (US).

The study design is a retrospective cohort study.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: fluticasone propionate/salmeterol 250µg/50µg (FSC), tiotropium bromide (TIO)
Keywords: chronic obstructive pulmonary disease, cost and cost analysis, bronchodilators, healthcare utilization, fluticasone propionate/salmeterol, tiotropium
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fluticasone propionate/salmeterol 250µg/50µg (FSC)Drug
Also called Advair®
Patient records with evidence of COPD and prescription claims for FSC
tiotropium bromide (TIO)Drug
Also called Spriva®
Patient records with evidence of COPD and prescription claims for TIO

Study groups in NCT01387178
Study group	Role	What they receive
COPD patients - risk analysis population		Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. Patient records for the risk analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 3 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and June 30, 2008). Receives: Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC); Drug: tiotropium bromide (TIO)
COPD patients - cost analysis population		Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. The cost analysis population is a subset of the risk analysis population. Patient records for the cost analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 12 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and September 30, 2007). Receives: Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC); Drug: tiotropium bromide (TIO)

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-index Period COPD-related, Unadjusted Costs
The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg [FSC] or tiotropium bromide [TIO]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.
Measured: 1 year
Mean Number of COPD Exacerbations
Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.
Measured: 1 year

Secondary outcomes (1)

Number of COPD-related Healthcare Encounters
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Feb 2010

First posted4 Jul 2011 (estimated)
Study startJul 2008
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 22,223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01387178
Sponsor's protocol ID: 111267
Status last verified: May 2017
First submitted: 16 Jun 2011
Last updated: 17 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT01387178
Acronym / sponsor ID: 111267
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: chronic obstructive pulmonary disease, cost and cost analysis, bronchodilators, healthcare utilization, fluticasone propionate/salmeterol, tiotropium
Study type: Observational
Recruitment status: Completed
Enrolment: 22,223 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 4 Jul 2011 (estimated)
Results: Posted 28 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study design is a retrospective cohort study.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
COPD patients - risk analysis population	–	Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC), Drug: tiotropium bromide (TIO)Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. Patient records for the risk analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 3 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and June 30, 2008).
COPD patients - cost analysis population	–	Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC), Drug: tiotropium bromide (TIO)Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. The cost analysis population is a subset of the risk analysis population. Patient records for the cost analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 12 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and September 30, 2007).

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patient records for commercially-insured patients with chronic obstructive pulmonary disease (COPD) aged 40 and older. For the risk-analysis population, patients were required to have at least 12 months of continuous enrollment prior to the index date and at least 3 months of continuous enrollment after the index date. A subgroup analysis was conducted for costs that included patients in the total population who also had at least 12 months of continuous coverage following the index date (the cost-analysis population).

Key inclusion criteria (4 listed)

Patient is age 40 or older
Patient record indicates a new prescription claim for fluticasone propionate/salmeterol (FSC) or tiotropium bromide (TIO) (first pharmacy claim defines the index date)
Patient records include at least two medical claims with a primary or non-primary diagnosis of COPD (International Classification of Disease-9 [ICD-9] code 490.xx - 492.xx or 496.xx)
At least one of the patient's ICD-9 codes for COPD is observed in the 12 months prior to the first pharmacy claim for FSC or TIO (the index date)

Key exclusion criteria (5 listed)

A pharmacy claim for FSC or TIO prior to the index date
The patient initiated FSC at a dose other than 250µg/50µg
The patient initiated FSC and TIO at the same time
The patient had one or more prescription with missing dosing information
The patient had a prescription claim for the study medication other than the one they started on at the index date within 60 days after the index date

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fluticasone propionate/salmeterol 250µg/50µg (FSC)Also: Advair®Patient records with evidence of COPD and prescription claims for FSC	Drug	COPD patients - cost analysis population, COPD patients - risk analysis population
tiotropium bromide (TIO)Also: Spriva®Patient records with evidence of COPD and prescription claims for TIO	Drug	COPD patients - cost analysis population, COPD patients - risk analysis population

Primary outcome

Post-index Period COPD-related, Unadjusted Costs
Time frame: 1 year
The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg [FSC] or tiotropium bromide [TIO]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.
Mean Number of COPD Exacerbations
Time frame: 1 year
Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.

1 secondary outcome

Number of COPD-related Healthcare Encounters
Time frame: 1 year

Results and safety

Results posted to the registry on 28 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg	11,582	11,582
Tiotropium Bromide 18 µg	10,641	10,641

Primary outcome: Post-index Period COPD-related, Unadjusted Costs

Time frame: 1 year. Mean (Standard Deviation). Unit: United States (US) dollars

Measure	Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg n = 7933	Tiotropium Bromide 18 µg n = 6372
Inpatient services	688 (4998)	867 (6887)
Emergency department visits	55 (415)	52 (363)
Inpatient and emergency department visits	743 (5090)	919 (6977)
Office visits	231 (388)	293 (559)
Other outpatient/ancillary services	734 (2504)	879 (3050)
Total medical costs	1709 (6322)	2091 (8302)
Total pharmacy costs	1291 (1791)	1209 (1378)
Total healthcare utilization	3000 (6805)	3299 (8536)

Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg: Adjusted Mean: 7451 (95% CI 5857 to 9045)
Tiotropium Bromide 18 µg: Adjusted Mean: 11545 (95% CI 8827 to 14263)
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg: Adjusted Mean: 61 (95% CI 58 to 63)

Population analysed: A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007

Primary outcome: Mean Number of COPD Exacerbations

Time frame: 1 year. Mean (Standard Deviation). Unit: number of exacerbations

Measure	Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg n = 11582	Tiotropium Bromide 18 µg n = 10641
Moderate Exacerbation	0.35 (0.77)	0.29 (0.71)
Severe Exacerbation	0.05 (0.29)	0.05 (0.32)
Any Exacerbation	0.4 (0.87)	0.34 (0.82)

Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg vs Tiotropium Bromide 18 µg: Hazard Ratio (HR): 0.964 (95% CI 0.909 to 1.022), p = 0.2198, Regression, Cox
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg vs Tiotropium Bromide 18 µg: Hazard Ratio (HR): 0.864 (95% CI 0.752 to 0.994), p = 0.0406, Regression, Cox
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg vs Tiotropium Bromide 18 µg: Hazard Ratio (HR): 0.953 (95% CI 0.901 to 1.009), p = 0.0962, Regression, Cox

Population analysed: The total population including participants with index dates between January 1,2004 and June 30, 2008.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg	0 of 0	0 of 0	Not reported
Tiotropium Bromide 18 µg	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Disease, Chronic Obstructive

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-index Period COPD-related, Unadjusted Costs (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01387178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.