AsthmaPhase 3NCT01498679
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 study testing GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate) in people with Asthma, run by GlaxoSmithKline at 28 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Asthma
- What is being tested?
- GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 311 participants
- Where
- 28 sitesin 3 countries
- Study dates
- Jan 2012to Jul 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
China16 sites
GSK Investigational Site
Beijing, 100029
GSK Investigational Site
Beijing, 100034
GSK Investigational Site
Beijing, 100050
GSK Investigational Site
Chongqing, 400037
GSK Investigational Site
Chongqing
GSK Investigational Site
Haikou, Hainan, 570311
GSK Investigational Site
Hangzhou, Zhejiang, 310003
GSK Investigational Site
Hangzhou, 310016
GSK Investigational Site
Nanning, Guangxi, 530021
GSK Investigational Site
Qingdao, Shandong, 266071
GSK Investigational Site
Shanghai, 200433
GSK Investigational Site
Shenyang, Liaoning, 110015
GSK Investigational Site
Shenzhen, Guangdong, 518020
GSK Investigational Site
Xi'an, Shaanxi, 710032
GSK Investigational Site
Yinchuan, Ningxia, 750004
GSK Investigational Site
Zhanjiang, Guangdong, 524001
South Korea10 sites
GSK Investigational Site
Bucheon-si, Gyeonggi-Do, 420-767
GSK Investigational Site
Cheongju, Chungcheongbuk-do, 361-711
GSK Investigational Site
Ilsanseo-gu, Goyang-si, Gyeonggi-do, 411706
GSK Investigational Site
Pusan, 602-739
GSK Investigational Site
Seongnam-si, Gyeonggi-do, 463-707
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 130-709
GSK Investigational Site
Seoul, 137-701
GSK Investigational Site
Seoul, 152-703
Philippines2 sites
GSK Investigational Site
Marilao, Bulacan, 3019
GSK Investigational Site
Quezon City, 1101
About this study
Official title: 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 Low to Mid-strength Inhaled Corticosteroid or Low-strength Combination Therapy.
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
- Asthma
- Being tested
- GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate), Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)Drug
ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI)
PlaceboDrug
Placebo administered once daily in the evening via a NDPI
| Study group | Role | What they receive |
|---|---|---|
| fluticasone furoate/vilanterol trifenatate | Active comparator | Inhaled corticosteroid (ICS)/Long-acting beta2-agonist (LABA) combination Receives: Drug: GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate) |
| Placebo | Placebo comparator | placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Weeks 1-12 (up to Day 84)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498679
- Sponsor's protocol ID
- 113719
- Status last verified
- Jan 2017
- First submitted
- 21 Dec 2011
- Last updated
- 8 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Low to Mid-strength Inhaled Corticosteroid or Low-strength Combination Therapy.
- ClinicalTrials.gov ID
- NCT01498679
- Acronym / sponsor ID
- 113719
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluticasone furoate/vilanterol trifenatate | Active comparator | Drug: GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)Inhaled corticosteroid (ICS)/Long-acting beta2-agonist (LABA) combination |
| Placebo | Placebo comparator | Drug: Placeboplacebo comparator |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI) | Drug | fluticasone furoate/vilanterol trifenatate |
| PlaceboPlacebo administered once daily in the evening via a NDPI | Drug | Placebo |
Primary outcome
Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
Time frame: Baseline and Weeks 1-12 (up to Day 84)
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.
4 secondary outcomes
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period
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
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
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
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27401316Lin 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate) in people with Asthma, run by GlaxoSmithKline at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China, South Korea, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period (time frame: Baseline and Weeks 1-12 (up to Day 84)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01498679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.