Pulmonary Disease, Chronic ObstructiveNCT01331694

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)

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.

Trial 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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: fluticasone/salmeterol combination (FSC) 250/50mcg, tiotropium and ipratropium bromide alone or in fixed dose combination with albuterol
How many people: 76,130 participants
Where: No sites listed yet
Study dates: Jul 2009to May 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: 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).

Who may be able to join

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.

Who cannot join

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).

About this study

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

Read the detailed description

All population i.e. at least 40 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). Six months of observation (continuous enrollment) prior to the index date is assessed to confirm that the patient meets the inclusion and exclusion criteria as well as to identify baseline characteristics and covariates. Cost analysis was done using a 12 months fixed follow up period. Outcome measures are assessed during the post-index period

Elderly cohort 65+: Identical methods and design were used for subanalyses in patients aged 65 years and over except comparison was FSC vs. TIO only.

75+ cohort: Identical methods and design were used for subanalyses in patients aged 75 years and over except comparison was FSC vs. TIO only.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: fluticasone/salmeterol combination (FSC) 250/50mcg, tiotropium, ipratropium bromide alone or in fixed dose combination with albuterol
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/salmeterol combination (FSC) 250/50mcgDrug
Also called Advair (TM)
patients initiating treatment with fluticasone/salmeterol combination (FSC) 250/50mcg
tiotropiumDrug
Also called Spiriva (TM)
patients initiating treatment with tiotropium
ipratropium bromide alone or in fixed dose combination with albuterolDrug
Also called Atrovent (TM), Combivent (TM)
patients initiating treatment with ipratropium/albuterol

Study groups in NCT01331694
Study group	Role	What they receive
COPD		copd patients 65 years and older Receives: Drug: fluticasone/salmeterol combination (FSC) 250/50mcg; Drug: tiotropium; Drug: ipratropium bromide alone or in fixed dose combination with albuterol

What is being measured

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

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

Secondary outcomes (1)

Average Annual Adjusted Post-Index COPD-Related Costs
Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists [LABA], inhaled corticosteroids [ICS], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs.
Measured: Incurred over the 12 month period after initial treatment arm prescription

Timeline

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

Jul 2009May 2010

First posted8 Apr 2011 (estimated)
Study startJul 2009
Primary completionMay 2010
Study completionMay 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.
Publications (1)Papers the sponsor has linked to this study.
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: 76,130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01331694
Sponsor's protocol ID: 112646
Status last verified: Aug 2011
First submitted: 10 Mar 2011
Last updated: 2 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21311689

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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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01331694
Acronym / sponsor ID: 112646
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 76,130 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 8 Apr 2011 (estimated)
Results: Posted 8 Apr 2011

Clinical summary

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

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

Detailed description

Elderly cohort 65+: Identical methods and design were used for subanalyses in patients aged 65 years and over except comparison was FSC vs. TIO only.

75+ cohort: Identical methods and design were used for subanalyses in patients aged 75 years and over except comparison was FSC vs. TIO only.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
COPD	–	Drug: fluticasone/salmeterol combination (FSC) 250/50mcg, Drug: tiotropium, Drug: ipratropium bromide alone or in fixed dose combination with albuterolcopd patients 65 years and older

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (6 listed)

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).

Key exclusion criteria (2 listed)

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).

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/salmeterol combination (FSC) 250/50mcgAlso: Advair (TM)patients initiating treatment with fluticasone/salmeterol combination (FSC) 250/50mcg	Drug	COPD
tiotropiumAlso: Spiriva (TM)patients initiating treatment with tiotropium	Drug	COPD
ipratropium bromide alone or in fixed dose combination with albuterolAlso: Atrovent (TM), Combivent (TM)patients initiating treatment with ipratropium/albuterol	Drug	COPD

Primary outcome

Time to First Chronic Obstructive Pulmonary Disease (COPD) Event
Time frame: Anytime from 30 days to 12 months after initial treatment arm prescription
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.

1 secondary outcome

Average Annual Adjusted Post-Index COPD-Related Costs
Time frame: Incurred over the 12 month period after initial treatment arm prescription

Results and safety

Results posted to the registry on 8 Apr 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
Risk Population: FSC	16,684	16,684
Risk Population: IP	14,449	14,449
Risk Population: TIO	12,659	12,659
Cost Population: FSC	12,595	12,595
Cost Population: IP	10,617	10,617
Cost Population: TIO	9,126	9,126

Primary outcome: Time to First Chronic Obstructive Pulmonary Disease (COPD) Event

Time frame: Anytime from 30 days to 12 months after initial treatment arm prescription. Mean (Standard Error). Unit: days

Measure	Risk Population: FSC n = 16684	Risk Population: IP n = 14449	Risk Population TIO n = 12659
Hospitalization or emergency department visit	325.17 (0.39)	315.89 (0.56)	321.59 (0.51)
Emergency department visit	330.24 (0.28)	324.47 (0.43)	328.48 (0.37)
Outpatient visit with oral steroid fill	332.74 (0.22)	328.23 (0.31)	331.23 (0.30)
Outpatient visit with antibiotic fill	329.96 (0.30)	326.73 (0.39)	326.70 (0.39)

Risk Population: FSC vs Risk Population: IP: Hazard Ratio (HR): 1.64 (95% CI 1.50 to 1.79)
Risk Population: FSC vs Risk Population TIO: Hazard Ratio (HR): 1.29 (95% CI 1.17 to 1.41)
Risk Population: FSC vs Risk Population: IP: Hazard Ratio (HR): 1.78 (95% CI 1.59 to 2.00)

Population analysed: All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Risk Population: FSC	0 of 0	0 of 0	Not reported
Risk Population: IP	0 of 0	0 of 0	Not reported
Risk Population: TIO	0 of 0	0 of 0	Not reported
Cost Population: FSC	0 of 0	0 of 0	Not reported
Cost Population: IP	0 of 0	0 of 0	Not reported
Cost Population: TIO	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 2 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21311689Dalal 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.

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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 6 inclusion and 2 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 2 Jul 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 8 Apr 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?

Time to First Chronic Obstructive Pulmonary Disease (COPD) Event (time frame: Anytime from 30 days to 12 months after initial treatment arm prescription). 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 NCT01331694, which also lists 1 linked publication.

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 2 Jul 2017.