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AsthmaPhase 3NCT01498653

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 and CCI18781 in people with Asthma, run by GlaxoSmithKline at 24 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with high-strength inhaled… 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 and CCI18781
Could I receive a placebo?
No, everyone receives an active treatment
How many people
313 participants
Where
24 sitesin 3 countries
Study dates
Jan 2012to Feb 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 an acceptable method of birth control consistently and correctly
  • 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 Asian adjustment
  • Reversibility of Disease: Demonstrated ≥12% and ≥200mL reversibility of FEV1 within 10-40minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or one nebulized 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.
  • 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.
Show all 14Show fewer
  • 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
  • Milk Protein Allergy: History of severe milk protein allergy.
  • Concomitant Medications: Use of the protocol defined prohibited medications within the prohibited time intervals prior to Screening (Visit 1) or during the study.
  • Tobacco Use: Current smoker or 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 FF/VI combination product study
  • 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

24 sites in 3 countries.

24 sites in 3 countries

China12 sites

  • GSK Investigational Site

    Beijing, 100020

  • GSK Investigational Site

    Beijing, 100029

  • GSK Investigational Site

    Beijing, 100191

  • GSK Investigational Site

    Changsha, Hunan, 410011

  • GSK Investigational Site

    Chongqing, 400037

  • GSK Investigational Site

    Chongqing, 400038

  • GSK Investigational Site

    Guangzhou, Guangdong, 510120

  • GSK Investigational Site

    Shanghai, 200025

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Shanghai, 200080

  • GSK Investigational Site

    Shenyang, Liaoning, 110001

  • GSK Investigational Site

    Shenyang, Liaoning, 110015

Other trials in China

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

Other trials in South Korea

Philippines2 sites

  • GSK Investigational Site

    Lipa City, 4217

  • GSK Investigational Site

    Quezon City, 1100

Other trials in Philippines

About this study

Official title: A Randomised, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate (FF/VI) Inhalation Powder Delivered Once Daily Compared to Fluticasone Propionate Delivered Twice Daily in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry Currently Treated With High-strength Inhaled Corticosteroids or Mid-strength ICS/LABA Combination Therapy.

A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination therapy

Read the detailed description

This will be a randomized, double-blind, active-comparator, parallel group, multi-center 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 randomization criteria will enter a 12 week treatment period and receive one of the two following treatments: 1) FF (200mcg)/VI (25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI) 2) Fluticasone propionate 500mcg administered twice daily via DISKUS™ Inhaler 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 randomization criteria at Visit 2 will be withdrawn from the study.

Subjects meeting the randomization 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 Contact (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 phase of the study (Screening, treatment, Follow-up).

Conditions
Asthma
Being tested
GW685698/GW642444, CCI18781
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW685698/GW642444Drug

    ICS/LABA

  • CCI18781Drug

    ICS

Study groups in NCT01498653
Study groupRoleWhat they receive
FF/VI 200/25mcg once dailyExperimentalICS/LABA
Receives: Drug: GW685698/GW642444
Fluticasone propionate 500mcg twice dailyActive comparatorICS
Receives: Drug: CCI18781

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.

    Measured: Baseline and Weeks 1-12 (up to Day 84)

  2. 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)

  3. 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 dairy 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)

  4. 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.

  1. First posted23 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01498653
Sponsor's protocol ID
113714
Status last verified
Nov 2016
First submitted
21 Dec 2011
Last updated
9 Jan 2017
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, Kang J, Lee SH, Wang C, Zhou X, Crawford J, Jacques L, Stone S. Fluticasone furoate/vilanterol 200/25 mcg in Asian asthma patients: a randomized trial. Respir Med. 2015 Jan;109(1):44-53. doi: 10.1016/j.rmed.2014.10.012. Epub 2014 Oct 31.

    PubMed 25524507

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GW685698/GW642444 and CCI18781 in people with Asthma, run by GlaxoSmithKline at 24 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 14 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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. 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 20 Dec 2013). 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 NCT01498653, 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 9 Jan 2017.

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