CompletedNCT01498679Updated Mar 8, 2017Results posted

Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.

A Phase 3 interventional study of GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate) and Placebo in Asthma, sponsored by GlaxoSmithKline. Completed at 28 sites in 3 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-03-08.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 311
Allocation: Randomized
Ages: 12 Years to 100 Years
Sex: All

Study summary

A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid or low-strength combination therapy.

Read the detailed description

This will be a randomised, double-blind, placebo controlled, parallel group, multi-centre study. At Visit 1 (Screening Visit) subjects who meet all of the inclusion criteria and none of the exclusion criteria will enter a two week run-in period. Subjects will remain on their current ICS therapy throughout the run-in period. At the end of the run-in period (Visit 2) subjects meeting the Randomisation criteria will enter a 12 week treatment period and receive one of the two following treatments: 1) FF/VI (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI) 2) Placebo administered once daily in the evening via a NDPI In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to be used as required to treat asthma symptoms.

Subjects who have not met the randomisation criteria at Visit 2 will be withdrawn from the study.

Subjects meeting the randomisation criteria will be randomized to one of the two treatment groups and will attend the clinic for 3 on-treatment visits at Week 4 (Visit 3), Week 8 (Visit 4) and Week 12 (Visit 5). Subjects will receive treatment for 12 weeks. A Follow-up Visit or phone call (Visit 6) will take place 1 week after completing study medication. All clinic visits will take place in the morning. Subjects will participate in the study for a maximum of 15 weeks (Screening to Follow-up inclusive). A subject is regarded to have completed the study if they complete all phases of the study (Screening, treatment, Follow-up).

Conditions studied

Asthma

Browse trials for

Asthma 3,921

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 311 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study.
Type of Subject: Outpatients, of Asian ancestry, 12 years of age or older at Visit 1 (or ≥18 years of age or older if local regulations or the regulatory status of study medication permit enrolment of adults only), with a diagnosis of asthma as defined by the Global Initiative for Asthma [GINA, 2009] at least 12 weeks prior to Visit 1.
Gender: Male or Eligible Female, defined as non-childbearing potential or childbearing potential using a protocol defined acceptable method of birth control consistently and correctly. Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required for females of childbearing potential at the initial Screening Visit (Visit 1) and Visit 5 or Early Withdrawal
Severity of Disease: A best FEV1 of 40%-90% of the predicted normal value at the Visit 1, Screening visit. Predicted values will be based upon NHANES III using the adjustment for Asians [Hankinson, 2010].
Reversibility of Disease: Demonstrated ≥12% and ≥200mL reversibility of FEV1 within 10-40minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or one nebulised treatment with albuterol/salbutamol solution) at the Screening Visit.
Current Anti-Asthma Therapy: All subjects must be using an ICS, with or without LABA, for at least 12 weeks prior to Visit 1, in accordance with the protocol defined acceptable dose ranges.
Short-Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhaler at Visit 1 for use as needed for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 4 hours prior to study visits

Exclusion criteria

Exclusion Criteria:

History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years.
Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma.
Other Concurrent Diseases/Abnormalities: A subjects must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of candidiasis at Visit 1.
Allergies: •Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate). •Milk Protein Allergy: History of severe milk protein allergy.
Concomitant Medications: Use of the protocol defined prohibited medications prior to Screening (Visit 1) or during the study, in accordance with the protocol.
Tobacco Use: Current smoker or subjects with a smoking history of 10 pack years (e.g., 20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, smokeless or pipe tobacco).
Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, Sub Investigator, study coordinator, or employee of the participating Investigator.
Previous Participation: A subject may not have previously been Randomized to treatment in another Phase III fluticasone furoate/VI combination product study (i.e., HZA113714, HZA106827, HZA106829, HZA106837, HZA106839, HZA106851, HZA113091).
Compliance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 311 participants (actual)

Study arms

Active comparator
fluticasone furoate/vilanterol trifenatate
Inhaled corticosteroid (ICS)/Long-acting beta2-agonist (LABA) combination
Drug: GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)
Placebo comparator
Placebo
placebo comparator
Drug: Placebo

Interventions

DrugGW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)
ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI)
DrugPlacebo
Placebo administered once daily in the evening via a NDPI

What researchers measure

Primary outcomes

Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.
Time frame: Baseline and Weeks 1-12 (up to Day 84)

Secondary outcomes

Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. A Repeated Measures analysis adjusted for Baseline, region, sex, age, treatment, week, week by Baseline interaction, and week by treatment interaction was used.
Time frame: Baseline and Weeks 1-12 (up to Day 84)
Mean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period
The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Time frame: Baseline and Weeks 1-12 (up to Day 84)
Mean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period
Asthma symptoms were recorded in a daily diary by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Time frame: Baseline and Weeks 1-12 (up to Day 84)
Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment." Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Time frame: Baseline and Week 12

Results

Posted Apr 1, 2014

Participant flow

A total of 311 participants were randomized to treatment. However, 4 participants were randomized in error and did not receive any study treatment. These participants were not included in the Intent-to-Treat (ITT) Population, which was comprised of all participants randomized to treatment who received \>=1 dose of trial medication.

Participant flow — Overall Study
Milestone	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily
Started	154	153
Completed	65	131
Not completed	89	22
Withdrew: Adverse event	1	4
Withdrew: Lack of efficacy	72	12
Withdrew: Protocol violation	4	0
Withdrew: Physician decision	0	2
Withdrew: Withdrawal by subject	12	4

Outcome measures

PrimaryMean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period

Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.

Time frame:: Baseline and Weeks 1-12 (up to Day 84)
Reported as:: Least squares mean · Liters/minute (L/min)

Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
Liters/minute (L/min)	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily
Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period	-11.8 ± 3.16	39.2 ± 3.14

Statistical analysis

Placebo vs Fluticasone Furoate/Vilanterol 100/25 µg Once Daily · ANCOVA · p = <0.001 · Least squares mean difference: 51.0 · 95% CI 42.2 to 59.7

SecondaryMean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. A Repeated Measures analysis adjusted for Baseline, region, sex, age, treatment, week, week by Baseline interaction, and week by treatment interaction was used.

Time frame:: Baseline and Weeks 1-12 (up to Day 84)
Reported as:: Least squares mean · L/min

Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period
L/min	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period	-9.3 ± 3.12	43.6 ± 3.12

SecondaryMean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period

The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

Time frame:: Baseline and Weeks 1-12 (up to Day 84)
Reported as:: Least squares mean · Percentage of rescue-free 24-hr periods

Mean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period
Percentage of rescue-free 24-hr periods	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily
Mean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period	8.3 ± 2.59	30.1 ± 2.60

SecondaryMean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period

Asthma symptoms were recorded in a daily diary by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

Time frame:: Baseline and Weeks 1-12 (up to Day 84)
Reported as:: Least squares mean · Percentage of symptom-free 24-hr periods

Mean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period
Percentage of symptom-free 24-hr periods	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily
Mean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period	9.0 ± 2.30	24.8 ± 2.31

SecondaryChange From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12

The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment." Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · Scores on a scale

Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
Scores on a scale	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily
Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12	0.33 ± 0.094	0.84 ± 0.068

Adverse events

Collected over On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow up (up to Study Day 91).. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	0/154 (0%)	27/154 (17.5%)
Fluticasone Furoate/Vilanterol 100/25 µg Once Daily	—	2/153 (1.3%)	24/153 (15.7%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily
Atrial fibrillationCardiac disorders	0/154	1/153
EnteritisGastrointestinal disorders	0/154	1/153

Most frequent other events

Most frequent other events
Event	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily
Upper respiratory tract infectionInfections and infestations	14/154	11/153
NasopharyngitisInfections and infestations	13/154	7/153
HeadacheNervous system disorders	3/154	7/153

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily	Total
Mean	47.4 ± 13.90	47.0 ± 14.01	47.2 ± 13.94

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily	Total
Female	88	83	171
Male	66	70	136

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Placebo	Fluticasone Furoate/Vilanterol 100/25 µg Once Daily	Total
Asian - East Asian Heritage	132	125	257
Asian - South East Asian Heritage	22	28	50

Study locations

28 sites

GSK Investigational Site
Shenzhen, Guangdong 518020, China
GSK Investigational Site
Zhanjiang, Guangdong 524001, China
GSK Investigational Site
Nanning, Guangxi 530021, China
GSK Investigational Site
Haikou, Hainan 570311, China
GSK Investigational Site
Shenyang, Liaoning 110015, China
GSK Investigational Site
Yinchuan, Ningxia 750004, China
GSK Investigational Site
Xian, Shaanxi 710032, China
GSK Investigational Site
Qingdao, Shandong 266071, China
GSK Investigational Site
Hang Zhou, Zhejiang 310003, China
GSK Investigational Site
Beijing, 100029, China
GSK Investigational Site
Beijing, 100034, China
GSK Investigational Site
Beijing, 100050, China
GSK Investigational Site
Chongqing, 400037, China
GSK Investigational Site
Chongqing, China
GSK Investigational Site
Hangzhou, 310016, China
GSK Investigational Site
Shanghai, 200433, China
GSK Investigational Site
Bucheon-si, Gyeonggi-Do, 420-767, Korea, Republic of
GSK Investigational Site
Cheongju, Chungcheongbuk-do, 361-711, Korea, Republic of
GSK Investigational Site
Ilsanseo-gu, Goyang-si, Gyeonggi-do, 411706, Korea, Republic of
GSK Investigational Site
Pusan, 602-739, Korea, Republic of
GSK Investigational Site
Seongnam-si, Gyeonggi-do, 463-707, Korea, Republic of
GSK Investigational Site
Seoul,, 120-752, Korea, Republic of
GSK Investigational Site
Seoul, 110-744, Korea, Republic of
GSK Investigational Site
Seoul, 130-709, Korea, Republic of
GSK Investigational Site
Seoul, 137-701, Korea, Republic of
GSK Investigational Site
Seoul, 152-703, Korea, Republic of
GSK Investigational Site
Marilao, Bulacan, 3019, Philippines
GSK Investigational Site
Quezon City, 1101, Philippines

References and documents

Publications

Lin J, Tang H, Chen P, Wang H, Kim MK, Crawford J, Jacques L, Stone S. Efficacy and safety evaluation of once-daily fluticasone furoate/vilanterol in Asian patients with asthma uncontrolled on a low- to mid-strength inhaled corticosteroid or low-dose inhaled corticosteroid/long-acting beta2-agonist. Allergy Asthma Proc. 2016 Jul;37(4):302-10. doi: 10.2500/aap.2016.37.3968. PubMed 27401316 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01498679
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Dec 23, 2011
Start date: Jan 2012
Primary completion: Jul 2013
Completion: Jul 2013
Results posted: Apr 1, 2014
Last update: Mar 8, 2017

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Asthma→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion