Trial · NCT01331694
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, GlaxoSmithKline; results first posted 2011-04-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT01331694. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01331694
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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)
- NCT number
- NCT01331694
- Status
- Completed
- Enrollment
- 76,130 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- fluticasone/salmeterol combination (FSC) 250/50mcg, tiotropium, ipratropium bromide alone or in fixed dose combination with albuterol
- First posted
- 2011-04-08
- Last updated
- 2017-07-02
- Results first posted
- 2011-04-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | 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. |
| Secondary | Average Annual Adjusted Post-Index COPD-Related Costs | Incurred over the 12 month period after initial treatment arm prescription | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Anytime from 30 days to 12 months after initial treatment arm prescription | 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. | days | MEAN |
| SECONDARY | Average Annual Adjusted Post-Index COPD-Related Costs | Incurred over the 12 month period after initial treatment arm prescription | 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 | United States dollars | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population: FSC | Hospitalization or emergency department visit | 325.17 | Standard Error 0.39 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population: IP | Hospitalization or emergency department visit | 315.89 | Standard Error 0.56 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population TIO | Hospitalization or emergency department visit | 321.59 | Standard Error 0.51 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population: FSC | Emergency department visit | 330.24 | Standard Error 0.28 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population: IP | Emergency department visit | 324.47 | Standard Error 0.43 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population TIO | Emergency department visit | 328.48 | Standard Error 0.37 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population: FSC | Outpatient visit with oral steroid fill | 332.74 | Standard Error 0.22 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population: IP | Outpatient visit with oral steroid fill | 328.23 | Standard Error 0.31 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population TIO | Outpatient visit with oral steroid fill | 331.23 | Standard Error 0.30 | days |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Event | Risk Population: FSC | Outpatient visit with antibiotic fill | 329.96 | Standard Error 0.30 | days |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Risk Population: FSC | 16,684 | |
| Overall Study | STARTED | Risk Population: IP | 14,449 | |
| Overall Study | STARTED | Risk Population: TIO | 12,659 | |
| Overall Study | STARTED | Cost Population: FSC | 12,595 | |
| Overall Study | STARTED | Cost Population: IP | 10,617 | |
| Overall Study | STARTED | Cost Population: TIO | 9,126 | |
| Overall Study | COMPLETED | Risk Population: FSC | 16,684 | |
| Overall Study | COMPLETED | Risk Population: IP | 14,449 | |
| Overall Study | COMPLETED | Risk Population: TIO | 12,659 | |
| Overall Study | COMPLETED | Cost Population: FSC | 12,595 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Risk Population: FSC | ||
| Total, all-cause mortality | Risk Population: IP | ||
| Total, all-cause mortality | Risk Population: TIO | ||
| Total, all-cause mortality | Cost Population: FSC | ||
| Total, all-cause mortality | Cost Population: IP | ||
| Total, all-cause mortality | Cost Population: TIO | ||
| Total, other adverse events | Risk Population: FSC | 0 | 0 |
| Total, other adverse events | Risk Population: IP | 0 | 0 |
| Total, other adverse events | Risk Population: TIO | 0 | 0 |
| Total, other adverse events | Cost Population: FSC | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21311689 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01331694
GET https://conductscience.org/api/trials/v1/NCT01331694/results?page=2