Trial Outcomes & Findings for A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma (NCT NCT02446418)

Last Updated: 2019-01-14

Results Overview

The ACT is a validated self-completed questionnaire consisting of 5 questions that evaluate asthma control during the past 4 weeks on a 5-point categorical scale. Total scores are calculated from the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the last assessment prior to randomization (Day 0). Change from Baseline was post-dose visit value minus the Baseline value. Least square mean change is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

423 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2019-01-14

Participant Flow

A total of 439 participants with persistent asthma were screened. The study was conducted at 63 centers in 2 countries: 43 in France and 20 in Germany from 09 July 2015 to 20 July 2017. Age value being reported for all participants is an approximate age accurate to within + or -1 year.

A total of 439 participants were screened for this study and 423 participants were randomized to treatment. Three of the randomized participants did not receive study treatment and were not included in the Intent-To-Treat (ITT) population.

Participant milestones

Participant milestones
Measure	Usual ICS/LABA Eligible participants received fixed combination inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) (Fluticasone propionate \[FP\]/ Salmeterol \[S\] 250/50 micrograms \[mcg\] or 500/50 mcg, 1 inhalation twice daily; or Budesonide \[BUD\]/ Formoterol \[F\] 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.	FF/VI Eligible participants received Fluticasone Furoate (FF)/ Vilanterol (VI) 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
Overall Study STARTED	210	210
Overall Study COMPLETED	192	194
Overall Study NOT COMPLETED	18	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual ICS/LABA Eligible participants received fixed combination inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) (Fluticasone propionate \[FP\]/ Salmeterol \[S\] 250/50 micrograms \[mcg\] or 500/50 mcg, 1 inhalation twice daily; or Budesonide \[BUD\]/ Formoterol \[F\] 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.	FF/VI Eligible participants received Fluticasone Furoate (FF)/ Vilanterol (VI) 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
Overall Study Adverse Event	4	8
Overall Study Physician Decision	5	1
Overall Study Withdrawal by Subject	3	3
Overall Study Lost to Follow-up	2	2
Overall Study Protocol Violation	1	2
Overall Study Lack of Efficacy	2	0
Overall Study Protocol defined stopping criteria reach	1	0

Baseline Characteristics

A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual ICS/LABA n=210 Participants Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.	FF/VI n=210 Participants Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.	Total n=420 Participants Total of all reporting groups
Age, Continuous	47.5 Years STANDARD_DEVIATION 14.99 • n=5 Participants	49.3 Years STANDARD_DEVIATION 14.67 • n=7 Participants	48.4 Years STANDARD_DEVIATION 14.84 • n=5 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	145 Participants n=7 Participants	269 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	65 Participants n=7 Participants	151 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	196 Participants n=5 Participants	196 Participants n=7 Participants	392 Participants n=5 Participants
Race/Ethnicity, Customized Mixed White Race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Usual ICS/LABA n=188 Participants Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.	FF/VI n=188 Participants Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12	2.8 Scores on a Scale Standard Error 0.26	3.6 Scores on a Scale Standard Error 0.26

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

The ACT is a validated self-completed questionnaire consisting of 5 questions that evaluate asthma control on a 5-point categorical scale. Total scores are calculated from the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the last assessment prior to randomization (Day 0). Change from Baseline was post-dose visit value minus the Baseline value. Least square mean change is presented.

Outcome measures

Outcome measures
Measure	Usual ICS/LABA n=184 Participants Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.	FF/VI n=180 Participants Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
Change From Baseline in ACT Total Score at Week 24	3.6 Scores on a Scale Standard Error 0.25	4.0 Scores on a Scale Standard Error 0.25

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Participants were asked to read the appropriate package insert for their prescribed inhaler and then the investigator (or suitably qualified designee) demonstrated the proper use of the inhaler. The participant was then asked to self-administer their first dose of study treatment under the supervision of the investigator and any critical and non-critical errors were recorded. Individual instruments for assessing correct inhaler use were provided for each of the three devices used in this study.

Outcome measures

Outcome measures
Measure	Usual ICS/LABA n=210 Participants Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.	FF/VI n=210 Participants Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
Percentage of Participants With Correct Use of Device, Defined as Not Making Any Critical or Non-critical Errors, at Week 12, and at Week 24 Independently of the Use at Week 12 Week 24; n= 191, 192	96 Percentage of participants	97 Percentage of participants
Percentage of Participants With Correct Use of Device, Defined as Not Making Any Critical or Non-critical Errors, at Week 12, and at Week 24 Independently of the Use at Week 12 Week 12; n= 195, 197	93 Percentage of participants	94 Percentage of participants

Adverse Events

Usual ICS/LABA

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

FF/VI

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Usual ICS/LABA n=210 participants at risk Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks.	FF/VI n=209 participants at risk Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks.
Infections and infestations Chronic sinusitis	0.48% 1/210 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.00% 0/209 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Infections and infestations Erysipelas	0.48% 1/210 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.00% 0/209 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Infections and infestations Labyrinthitis	0.00% 0/210 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.48% 1/209 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Infections and infestations Ovarian abscess	0.00% 0/210 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.48% 1/209 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Gastrointestinal disorders Abdominal pain	0.48% 1/210 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.00% 0/209 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Nervous system disorders Epilepsy	0.48% 1/210 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.00% 0/209 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Reproductive system and breast disorders Adnexa uteri pain	0.00% 0/210 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.48% 1/209 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Skin and subcutaneous tissue disorders Skin ulcer	0.48% 1/210 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.00% 0/209 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Vascular disorders Varicose vein ruptured	0.00% 0/210 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.	0.48% 1/209 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24 On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

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