Trial · NCT01337336
Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population
NCT01337336, Completed, GlaxoSmithKline; results first posted 2011-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population. Trials, record NCT01337336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01337336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population
- NCT number
- NCT01337336
- Status
- Completed
- Enrollment
- 1 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- fluticasone propionate/salmeterol xinafoate, Anticholinergics
- First posted
- 2011-04-18
- Last updated
- 2017-05-30
- Results first posted
- 2011-05-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation | Maximum of 1 year after index date (January 1, 2004 to June 30, 2009) | The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008. |
| Secondary | Number of Participants With the Indicated COPD-related Exacerbations | Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) | The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008. |
| Secondary | Mean Annual COPD-related Costs Per Participant | Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) | Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008. |
| Secondary | Number of the Indicated COPD-related Exacerbations | Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) | The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation | Maximum of 1 year after index date (January 1, 2004 to June 30, 2009) | Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date). | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated COPD-related Exacerbations | Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) | Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintanance medication for COPD (index date). | participants | NUMBER |
| SECONDARY | Mean Annual COPD-related Costs Per Participant | Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) | Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date). | United States (US) dollars | MEAN |
| SECONDARY | Number of the Indicated COPD-related Exacerbations | Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) | Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date). | number of exacerbations | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation | FSC Cohort | 200 | participants | ||
| Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation | AC Cohort | 674 | participants | ||
| Number of Participants With the Indicated COPD-related Exacerbations | FSC Cohort | COPD-related hospitalization | 35 | participants | |
| Number of Participants With the Indicated COPD-related Exacerbations | AC Cohort | COPD-related hospitalization | 168 | participants | |
| Number of Participants With the Indicated COPD-related Exacerbations | FSC Cohort | COPD-related ER visit | 37 | participants | |
| Number of Participants With the Indicated COPD-related Exacerbations | AC Cohort | COPD-related ER visit | 171 | participants | |
| Number of Participants With the Indicated COPD-related Exacerbations | FSC Cohort | COPD-related physician + Rx visit | 156 | participants | |
| Number of Participants With the Indicated COPD-related Exacerbations | AC Cohort | COPD-related physician + Rx visit | 448 | participants | |
| Number of Participants With the Indicated COPD-related Exacerbations | FSC Cohort | COPD-related hospitalization/ER visit | 63 | participants | |
| Number of Participants With the Indicated COPD-related Exacerbations | AC Cohort | COPD-related hospitalization/ER visit | 307 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FSC Cohort | 1,078 | |
| Overall Study | STARTED | AC Cohort | 2,923 | |
| Overall Study | COMPLETED | FSC Cohort | 1,078 | |
| Overall Study | COMPLETED | AC Cohort | 2,923 | |
| Overall Study | NOT COMPLETED | FSC Cohort | 0 | |
| Overall Study | NOT COMPLETED | AC Cohort | 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 | FSC Cohort | ||
| Total, all-cause mortality | AC Cohort | ||
| Total, other adverse events | FSC Cohort | 0 | 0 |
| Total, other adverse events | AC Cohort | 0 | 0 |
| Total, serious adverse events | FSC Cohort | 0 | 0 |
| Total, serious adverse events | AC Cohort | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| FSC Cohort vs AC Cohort: Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation |
Source Trial comparisons
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/NCT01337336
GET https://conductscience.org/api/trials/v1/NCT01337336/results?page=2