Trial · NCT01387178
Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
NCT01387178, Completed, GlaxoSmithKline; results first posted 2011-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease. Trials, record NCT01387178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01387178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
- NCT number
- NCT01387178
- Status
- Completed
- Enrollment
- 22,223 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- fluticasone propionate/salmeterol 250µg/50µg (FSC), tiotropium bromide (TIO)
- First posted
- 2011-07-04
- Last updated
- 2017-05-17
- Results first posted
- 2011-10-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-index Period COPD-related, Unadjusted Costs | 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. |
| Primary | Mean Number of COPD Exacerbations | 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. |
| Secondary | Number of COPD-related Healthcare Encounters | 1 year |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Post-index Period COPD-related, Unadjusted Costs | 1 year | A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007 | United States (US) dollars | MEAN |
| PRIMARY | Mean Number of COPD Exacerbations | 1 year | The total population including participants with index dates between January 1,2004 and June 30, 2008. | number of exacerbations | MEAN |
| SECONDARY | Number of COPD-related Healthcare Encounters | 1 year | A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007 | number of encounters | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post-index Period COPD-related, Unadjusted Costs | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | Inpatient services | 688 | Standard Deviation 4998 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Tiotropium Bromide 18 µg | Inpatient services | 867 | Standard Deviation 6887 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | Emergency department visits | 55 | Standard Deviation 415 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Tiotropium Bromide 18 µg | Emergency department visits | 52 | Standard Deviation 363 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | Inpatient and emergency department visits | 743 | Standard Deviation 5090 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Tiotropium Bromide 18 µg | Inpatient and emergency department visits | 919 | Standard Deviation 6977 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | Office visits | 231 | Standard Deviation 388 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Tiotropium Bromide 18 µg | Office visits | 293 | Standard Deviation 559 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | Other outpatient/ancillary services | 734 | Standard Deviation 2504 | United States (US) dollars |
| Post-index Period COPD-related, Unadjusted Costs | Tiotropium Bromide 18 µg | Other outpatient/ancillary services | 879 | Standard Deviation 3050 | United States (US) dollars |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | 11,582 | |
| Overall Study | STARTED | Tiotropium Bromide 18 µg | 10,641 | |
| Overall Study | COMPLETED | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | 11,582 | |
| Overall Study | COMPLETED | Tiotropium Bromide 18 µg | 10,641 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | 0 | |
| Overall Study | NOT COMPLETED | Tiotropium Bromide 18 µg | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | ||
| Total, all-cause mortality | Tiotropium Bromide 18 µg | ||
| Total, other adverse events | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | 0 | 0 |
| Total, other adverse events | Tiotropium Bromide 18 µg | 0 | 0 |
| Total, serious adverse events | Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg | 0 | 0 |
| Total, serious adverse events | Tiotropium Bromide 18 µg | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01387178
GET https://conductscience.org/api/trials/v1/NCT01387178/results?page=2