Trial · NCT01706198
An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
NCT01706198, Phase 3, Completed, GlaxoSmithKline; results first posted 2019-01-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma. Trials, record NCT01706198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01706198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
- NCT number
- NCT01706198
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,233 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- fluticasone furoate + vilanterol, inhaled corticosteroid with or without a long acting beta2-agonist
- First posted
- 2012-10-15
- Last updated
- 2019-01-24
- Results first posted
- 2019-01-24
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. | Baseline (Day 0) and Week 24 | The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of \<20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score \>=20 or an increase from Baseline of \>=3 has been presented |
| Secondary | Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. | Baseline (Day 0) and Weeks 12, 40 and 52 | The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score \>=20 or an increase from Baseline of \>=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Secondary | Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52. | Weeks 12, 24, 40 and 52 | The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score \>=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Secondary | Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52. | Baseline (Day 0) and Weeks 12, 24, 40 and 52 | The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score \>=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Secondary | Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52. | Baseline (Day 0) and Weeks 12, 24, 40 and 52 | The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Secondary | Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52. | Weeks 12, 24, 40 and 52 | The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is \>=20, 16 to 19 and \<=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Secondary | Annual Rate of Asthma-related Secondary Care Contacts | Up to Week 52 | All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A\&E) contact. A participant with an A\&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented. |
| Secondary | Annual Rate of Asthma-related Primary Care Contacts | Up to Week 52 | All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented. |
| Secondary | Number of Participants With Time to First Asthma-related Primary Care Contact | Up to Week 52 | Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis. |
| Secondary | Annual Rate of All On-treatment Secondary Care Contacts | Up to Week 52 | A secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an A\&E contact. A participant with an A\&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. | Baseline (Day 0) and Week 24 | PEA Population. Only participants with non-missing ACT score were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. | Baseline (Day 0) and Weeks 12, 40 and 52 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52. | Weeks 12, 24, 40 and 52 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52. | Baseline (Day 0) and Weeks 12, 24, 40 and 52 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52. | Baseline (Day 0) and Weeks 12, 24, 40 and 52 | ITT Population | Scores on ACT scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52. | Weeks 12, 24, 40 and 52 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Annual Rate of Asthma-related Secondary Care Contacts | Up to Week 52 | ITT Population | Contacts per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Annual Rate of Asthma-related Primary Care Contacts | Up to Week 52 | ITT Population | Contacts per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Time to First Asthma-related Primary Care Contact | Up to Week 52 | ITT Population | Participants | NUMBER |
| SECONDARY | Annual Rate of All On-treatment Secondary Care Contacts | Up to Week 52 | ITT Population | Contacts per participant per year | LEAST_SQUARES_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. | Usual Care | 56 | Percentage of participants | ||
| Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. | FF/VI | 71 | Percentage of participants | ||
| Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. | Usual Care | Week 12, n=2032, 2009 | 62 | Percentage of participants | |
| Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. | FF/VI | Week 12, n=2032, 2009 | 75 | Percentage of participants | |
| Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. | Usual Care | Week 40, n=1938, 1904 | 60 | Percentage of participants | |
| Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. | FF/VI | Week 40, n=1938, 1904 | 71 | Percentage of participants | |
| Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. | Usual Care | Week 52, n=1922, 1896 | 58 | Percentage of participants | |
| Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. | FF/VI | Week 52, n=1922, 1896 | 70 | Percentage of participants | |
| Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52. | Usual Care | Week 12, n=2032, 2009 | 46 | Percentage of participants | |
| Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52. | FF/VI | Week 12, n=2032, 2009 | 61 | Percentage of participants |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Usual Care | 2,119 | |
| Overall Study | STARTED | FF/VI | 2,114 | |
| Overall Study | COMPLETED | Usual Care | 1,946 | |
| Overall Study | COMPLETED | FF/VI | 1,920 | |
| Overall Study | NOT COMPLETED | Usual Care | 173 | |
| Overall Study | NOT COMPLETED | FF/VI | 194 |
Source ClinicalTrials.gov
Adverse events764
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Usual Care | 3 | 2,119 | 3 |
| serious | Anaemia | Blood and lymphatic system disorders | FF/VI | 3 | 2,114 | 3 |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | Usual Care | 1 | 2,119 | 1 |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | FF/VI | 0 | 2,114 | 0 |
| serious | Lymphadenopathy mediastinal | Blood and lymphatic system disorders | Usual Care | 1 | 2,119 | 1 |
| serious | Lymphadenopathy mediastinal | Blood and lymphatic system disorders | FF/VI | 0 | 2,114 | 0 |
| serious | Microcytic anaemia | Blood and lymphatic system disorders | Usual Care | 0 | 2,119 | 0 |
| serious | Microcytic anaemia | Blood and lymphatic system disorders | FF/VI | 1 | 2,114 | 1 |
| serious | Pancytopenia | Blood and lymphatic system disorders | Usual Care | 1 | 2,119 | 1 |
| serious | Pancytopenia | Blood and lymphatic system disorders | FF/VI | 0 | 2,114 | 0 |
1 to 10 of 764Source ClinicalTrials.gov
See all 764 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care | 27 | 2,119 |
| Total, all-cause mortality | FF/VI | 15 | 2,114 |
| Total, other adverse events | Usual Care | 0 | 2,119 |
| Total, other adverse events | FF/VI | 0 | 2,114 |
| Total, serious adverse events | Usual Care | 284 | 2,119 |
| Total, serious adverse events | FF/VI | 284 | 2,114 |
Source ClinicalTrials.gov
Papers7
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FF/VI vs Usual Care: Number of Participants With Fatal SAEs of Pneumonia | Trial comparisons |
| FF/VI vs Usual Care: Number of Participants With SAEs | Trial comparisons |
| FF/VI vs Usual Care: Time to First Severe Asthma Exacerbation. | Trial comparisons |
| FF/VI vs Usual Care: Time to Modification of Initial Therapy | Trial comparisons |
| FF/VI vs Usual Care: Time to First SAE of Pneumonia | Trial comparisons |
| FF/VI vs Usual Care: Number of Participants With Adverse Drug Reactions (ADRs) | Trial comparisons |
| FF/VI vs Usual Care: deaths from any cause | Trial comparisons |
| FF/VI vs Usual Care: 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/NCT01706198
GET https://conductscience.org/api/trials/v1/NCT01706198/registered?page=2