Trial · NCT01475721
SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
NCT01475721, Phase 4, Completed, GlaxoSmithKline; results first posted 2016-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma. Trials, record NCT01475721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01475721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
- NCT number
- NCT01475721
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 11,751 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- ADVAIR 100/50mcg, ADVAIR 250/50mcg, ADVAIR 500/50mcg, FLOVENT 100mcg, FLOVENT 250mcg, FLOVENT 500mcg
- First posted
- 2011-11-21
- Last updated
- 2018-08-06
- Results first posted
- 2016-01-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | From Day 1 up to 26 weeks | Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95. |
| Primary | Number of Participants Experiencing at Least One Asthma Exacerbation | From Day 1 up to 26 weeks | An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. |
| Secondary | Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death | From Day 1 up to 26 weeks | Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. |
| Secondary | Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation | From Day 1 up to 26 weeks | An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. |
| Secondary | Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours | From Day 1 up to 26 weeks | Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | From Day 1 up to 26 weeks | Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug. | Participants | NUMBER |
| PRIMARY | Number of Participants Experiencing at Least One Asthma Exacerbation | From Day 1 up to 26 weeks | Modified intent to treat (mITT) Population comprised of participants included in the ITT population that correspond to each participant's period of exposure to study drug plus seven days after the last date of study drug treatment. | Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death | From Day 1 up to 26 weeks | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation | From Day 1 up to 26 weeks | mITT Population | Participants | NUMBER |
| SECONDARY | Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours | From Day 1 up to 26 weeks | mITT Population. Only those participants available at specified timepoint were analysed. | Number of Puffs | 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 |
|---|---|---|---|---|---|
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | Fluticasone Propionate/Salmeterol Combination (FSC) | 34 | Participants | ||
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | Fluticasone Propionate (FP) | 33 | Participants | ||
| Number of Participants Experiencing at Least One Asthma Exacerbation | Fluticasone Propionate/Salmeterol Combination (FSC) | 480 | Participants | ||
| Number of Participants Experiencing at Least One Asthma Exacerbation | Fluticasone Propionate (FP) | 597 | Participants | ||
| Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death | Fluticasone Propionate/Salmeterol Combination (FSC) | Hospitalization | 34 | Participants | |
| Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death | Fluticasone Propionate (FP) | Hospitalization | 33 | Participants | |
| Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death | Fluticasone Propionate/Salmeterol Combination (FSC) | Endotracheal intubation | 0 | Participants | |
| Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death | Fluticasone Propionate (FP) | Endotracheal intubation | 2 | Participants | |
| Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death | Fluticasone Propionate/Salmeterol Combination (FSC) | Death | 0 | Participants | |
| Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death | Fluticasone Propionate (FP) | Death | 0 | Participants |
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/Salmeterol Combination (FSC) | 5,834 | |
| Overall Study | STARTED | Fluticasone Propionate (FP) | 5,845 | |
| Overall Study | COMPLETED | Fluticasone Propionate/Salmeterol Combination (FSC) | 5,823 | |
| Overall Study | COMPLETED | Fluticasone Propionate (FP) | 5,831 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate/Salmeterol Combination (FSC) | 11 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate (FP) | 14 |
Source ClinicalTrials.gov
Adverse events328
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Fluticasone Propionate/Salmeterol Combination (FSC) | 46 | 5,834 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Fluticasone Propionate (FP) | 75 | 5,845 | |
| serious | Anaemia | Blood and lymphatic system disorders | Fluticasone Propionate/Salmeterol Combination (FSC) | 3 | 5,834 | 3 |
| serious | Anaemia | Blood and lymphatic system disorders | Fluticasone Propionate (FP) | 1 | 5,845 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Fluticasone Propionate/Salmeterol Combination (FSC) | 3 | 5,834 | 3 |
| serious | Atrial fibrillation | Cardiac disorders | Fluticasone Propionate (FP) | 0 | 5,845 | 0 |
| serious | Angina pectoris | Cardiac disorders | Fluticasone Propionate/Salmeterol Combination (FSC) | 0 | 5,834 | 0 |
| serious | Angina pectoris | Cardiac disorders | Fluticasone Propionate (FP) | 2 | 5,845 | 2 |
| serious | Angina unstable | Cardiac disorders | Fluticasone Propionate/Salmeterol Combination (FSC) | 2 | 5,834 | 2 |
| serious | Angina unstable | Cardiac disorders | Fluticasone Propionate (FP) | 0 | 5,845 | 0 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone Propionate/Salmeterol Combination (FSC) | ||
| Total, all-cause mortality | Fluticasone Propionate (FP) | ||
| Total, other adverse events | Fluticasone Propionate/Salmeterol Combination (FSC) | 46 | 5,834 |
| Total, other adverse events | Fluticasone Propionate (FP) | 75 | 5,845 |
| Total, serious adverse events | Fluticasone Propionate/Salmeterol Combination (FSC) | 134 | 5,834 |
| Total, serious adverse events | Fluticasone Propionate (FP) | 125 | 5,845 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): Number of Participants Experiencing at Least One Asthma Exacerbation | Trial comparisons |
| Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation | Trial comparisons |
Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | Trial comparisons |
| Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): serious adverse events | 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/NCT01475721
GET https://conductscience.org/api/trials/v1/NCT01475721/events?page=2