Trial · NCT01347060
Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
NCT01347060, Completed, GlaxoSmithKline; results first posted 2011-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy. Trials, record NCT01347060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01347060
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
- NCT number
- NCT01347060
- Status
- Completed
- Enrollment
- 17,448 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- fluticasone propionate/salmeterol xinafoate combination, inhaled corticosteroids
- First posted
- 2011-05-04
- Last updated
- 2017-05-25
- Results first posted
- 2011-06-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Up to 7 years from July 1, 2001 to June 30, 2008 | Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database. |
| Secondary | Mean Asthma-related Costs in the Post-index Period | Up to 7 years from July 1, 2001 to June 30, 2008 | Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill. |
| Secondary | Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant | Up to 7 years from July 1, 2001 to June 30, 2008 | The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms. |
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 | Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Up to 7 years from July 1, 2001 to June 30, 2008 | Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study. | Asthma-related events | MEAN |
| SECONDARY | Mean Asthma-related Costs in the Post-index Period | Up to 7 years from July 1, 2001 to June 30, 2008 | Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study. | United States dollars | MEAN |
| SECONDARY | Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant | Up to 7 years from July 1, 2001 to June 30, 2008 | Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study. | albuterol canisters | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Fluticasone Propionate and Salmeterol | Inpatient visits | 0.033 | Standard Deviation 0.21 | Asthma-related events |
| Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Inhaled Corticosteroids | Inpatient visits | 0.046 | Standard Deviation 0.25 | Asthma-related events |
| Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Fluticasone Propionate and Salmeterol | Emergency department visits | 0.022 | Standard Deviation 0.18 | Asthma-related events |
| Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Inhaled Corticosteroids | Emergency department visits | 0.027 | Standard Deviation 0.20 | Asthma-related events |
| Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Fluticasone Propionate and Salmeterol | Inpatient/emergency department visits | 0.05 | Standard Deviation 0.30 | Asthma-related events |
| Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Inhaled Corticosteroids | Inpatient/emergency department visits | 0.07 | Standard Deviation 0.35 | Asthma-related events |
| Mean Asthma-related Costs in the Post-index Period | Fluticasone Propionate and Salmeterol | Medical Services Costs | 381 | Standard Deviation 2859 | United States dollars |
| Mean Asthma-related Costs in the Post-index Period | Inhaled Corticosteroids | Medical Services Costs | 462 | Standard Deviation 2859 | United States dollars |
| Mean Asthma-related Costs in the Post-index Period | Fluticasone Propionate and Salmeterol | Pharmacy Costs | 1128 | Standard Deviation 1077 | United States dollars |
| Mean Asthma-related Costs in the Post-index Period | Inhaled Corticosteroids | Pharmacy Costs | 939 | Standard Deviation 1125 | United States dollars |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 and Salmeterol | 9,868 | |
| Overall Study | STARTED | Inhaled Corticosteroids | 7,580 | |
| Overall Study | COMPLETED | Fluticasone Propionate and Salmeterol | 9,868 | |
| Overall Study | COMPLETED | Inhaled Corticosteroids | 7,580 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate and Salmeterol | 0 | |
| Overall Study | NOT COMPLETED | Inhaled Corticosteroids | 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 and Salmeterol | ||
| Total, all-cause mortality | Inhaled Corticosteroids | ||
| Total, other adverse events | Fluticasone Propionate and Salmeterol | 0 | 0 |
| Total, other adverse events | Inhaled Corticosteroids | 0 | 0 |
| Total, serious adverse events | Fluticasone Propionate and Salmeterol | 0 | 0 |
| Total, serious adverse events | Inhaled Corticosteroids | 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/NCT01347060
GET https://conductscience.org/api/trials/v1/NCT01347060/registered