Trial · NCT01086384
Asthma Exacerbation Study
NCT01086384, Phase 3, Completed, GlaxoSmithKline; results first posted 2013-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Asthma Exacerbation Study. Trials, record NCT01086384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01086384
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Asthma Exacerbation Study
- NCT number
- NCT01086384
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,020 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- Fluticasone Furoate/GW642444, Fluticasone furoate
- First posted
- 2010-03-15
- Last updated
- 2018-01-24
- Results first posted
- 2013-09-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With 1 or More Severe Asthma Exacerbations | Baseline to Follow-up (up to 76 weeks of treatment) | Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second \[FEV1, maximum amount of air forcefully exhaled in one second\]), sex, age, and region. |
| Secondary | Number of Severe Asthma Exacerbations | Baseline to Follow-up (up to 76 weeks of treatment) | A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations. |
| Secondary | Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36 | Baseline and Week 36 | Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value. |
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 | Number of Participants With 1 or More Severe Asthma Exacerbations | Baseline to Follow-up (up to 76 weeks of treatment) | Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Severe Asthma Exacerbations | Baseline to Follow-up (up to 76 weeks of treatment) | ITT Population | Severe asthma exacerbations | NUMBER |
| SECONDARY | Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36 | Baseline and Week 36 | ITT Population. Only those participants available at the indicated time point (Week 36) were analyzed. | Liters | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
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 1 or More Severe Asthma Exacerbations | FF 100 µg | 186 | participants | ||
| Number of Participants With 1 or More Severe Asthma Exacerbations | FF/VI 100/25 µg | 154 | participants | ||
| Number of Severe Asthma Exacerbations | FF 100 µg | 271 | Severe asthma exacerbations | ||
| Number of Severe Asthma Exacerbations | FF/VI 100/25 µg | 200 | Severe asthma exacerbations | ||
| Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36 | FF 100 µg | 0.265 | Standard Deviation 0.014 | Liters | |
| Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36 | FF/VI 100/25 µg | 0.348 | Standard Deviation 0.014 | Liters |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 2-week Run-in Period | STARTED | FP 250 µg/ICS | 2,183 | |
| 2-week Run-in Period | STARTED | FF 100 µg | 0 | |
| 2-week Run-in Period | STARTED | FF/VI 100/25 µg | 0 | |
| 2-week Run-in Period | COMPLETED | FP 250 µg/ICS | 2,020 | |
| 2-week Run-in Period | COMPLETED | FF 100 µg | 0 | |
| 2-week Run-in Period | COMPLETED | FF/VI 100/25 µg | 0 | |
| 2-week Run-in Period | NOT COMPLETED | FP 250 µg/ICS | 163 | |
| 2-week Run-in Period | NOT COMPLETED | FF 100 µg | 0 | |
| 2-week Run-in Period | NOT COMPLETED | FF/VI 100/25 µg | 0 | |
| Treatment Period | STARTED | FP 250 µg/ICS | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events138
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 | Nasopharyngitis | Infections and infestations | FF 100 µg | 131 | 1,010 | |
| other | Nasopharyngitis | Infections and infestations | FF/VI 100/25 µg | 155 | 1,009 | |
| other | Upper respiratory tract infection | Infections and infestations | FF 100 µg | 93 | 1,010 | |
| other | Upper respiratory tract infection | Infections and infestations | FF/VI 100/25 µg | 73 | 1,009 | |
| other | Bronchitis | Infections and infestations | FF 100 µg | 74 | 1,010 | |
| other | Bronchitis | Infections and infestations | FF/VI 100/25 µg | 59 | 1,009 | |
| other | Influenza | Infections and infestations | FF 100 µg | 38 | 1,010 | |
| other | Influenza | Infections and infestations | FF/VI 100/25 µg | 50 | 1,009 | |
| other | Sinusitus | Infections and infestations | FF 100 µg | 38 | 1,010 | |
| other | Sinusitus | Infections and infestations | FF/VI 100/25 µg | 42 | 1,009 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FF 100 µg | ||
| Total, all-cause mortality | FF/VI 100/25 µg | ||
| Total, other adverse events | FF 100 µg | 479 | 1,010 |
| Total, other adverse events | FF/VI 100/25 µg | 467 | 1,009 |
| Total, serious adverse events | FF 100 µg | 29 | 1,010 |
| Total, serious adverse events | FF/VI 100/25 µg | 41 | 1,009 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FF 100 µg vs FF/VI 100/25 µg: Number of Participants With 1 or More Severe Asthma Exacerbations | Trial comparisons |
| FF 100 µg vs FF/VI 100/25 µg: 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/NCT01086384
GET https://conductscience.org/api/trials/v1/NCT01086384/events?page=2