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AsthmaPhase 3NCT01147848

HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

A Phase 3 study testing Fluticasone furoate/Vilanterol Inhalation Powder and Fluticasone propionate/salmeterol Inhalation Powder in people with Asthma, run by GlaxoSmithKline at 63 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Fluticasone furoate/Vilanterol Inhalation Powder and Fluticasone propionate/salmeterol Inhalation Powder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
810 participants
Where
63 sitesin 6 countries
Study dates
Jun 2010to Jul 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosis of asthma
  • Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
  • FEV1 of 40-85% predicted normal
  • Currently using inhaled corticosteroid therapy

Who cannot join

  • History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
  • Respiratory infection or oral candidiasis
  • Asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment
  • Uncontrolled disease or clinical abnormality
  • Allergies
  • Taking another investigational medication or prohibited medication
  • Night shift workers
  • Current smokers or subjects with smoking history of at least 10 pack years

Trial locations and contacts

63 sites in 6 countries.

63 sites in 6 countries

United States25 sites

  • GSK Investigational Site

    Austin, Texas, 78750

  • GSK Investigational Site

    Bethesda, Maryland, 20814

  • GSK Investigational Site

    Centennial, Colorado, 80112

  • GSK Investigational Site

    Cherry Hill, New Jersey, 08003

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Cocoa, Florida, 32927

  • GSK Investigational Site

    Denver, Colorado, 80230

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rolla, Missouri, 65401

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    Skillman, New Jersey, 08558

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Wheaton, Maryland, 20902

Other trials in United States

Argentina10 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1425

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Mendoza, Mendoza Province, M5500CCG

  • GSK Investigational Site

    Paraná, Entre Ríos Province, E3100BHK

  • GSK Investigational Site

    Quilmes, Buenos Aires, B1878FNR

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000DSR

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000JKR

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Netherlands8 sites

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Breda, 4819 EV

  • GSK Investigational Site

    Dordrecht, 3318 AT

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Veldhoven, 5504 DB

Other trials in Netherlands

Chile7 sites

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Rancagua, Reg Del Libert Bern Ohiggins, 2841959

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500691

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7601003

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

  • GSK Investigational Site

    Viña del Mar, Valparaiso

Other trials in Chile

South Korea7 sites

  • GSK Investigational Site

    Cheongju, Chungcheongbuk-do, 361-711

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Philippines6 sites

  • GSK Investigational Site

    Cabanatuan City, Nueva Ecija, 3100

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Dasmariñas, Cavite, 4114

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Marilao, Bulacan, 3019

  • GSK Investigational Site

    Quezon City, 1100

Other trials in Philippines

About this study

Official title: A Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Assess Efficacy and Safety of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Propionate/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Conditions
Asthma
Being tested
Fluticasone furoate/Vilanterol Inhalation Powder, Fluticasone propionate/salmeterol Inhalation Powder, Placebo (1), Placebo (2)
Keywords
Salmeterol, fluticasone furoate, Vilanterol, fluticasone propionate, GW642444
Medical subject headings
Asthma

What participants receive

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

  • Fluticasone furoate/Vilanterol Inhalation PowderDrug

    Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks

  • Fluticasone propionate/salmeterol Inhalation PowderDrug

    Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks

  • Placebo (1)Drug

    Inhalation powder inhaled orally once daily for 24 weeks

  • Placebo (2)Drug

    Inhalation powder inhaled orally twice daily for 24 weeks

Study groups in NCT01147848
Study groupRoleWhat they receive
Fluticasone furoate/Vilanterol (GW642444)ExperimentalFluticasone furoate/vilanterol inhalation powder once daily + placebo inhalation powder twice daily for 24 weeks
Receives: Drug: Fluticasone furoate/Vilanterol Inhalation Powder; Drug: Placebo (2)
Fluticasone propionate/salmeterolActive comparatorFluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks
Receives: Drug: Fluticasone propionate/salmeterol Inhalation Powder; Drug: Placebo (1)

What is being measured

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

  1. Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24

    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.

    Measured: Baseline and Day 168/Week 24

Secondary outcomes (6)

  1. Serial FEV1 (0-24 Hours)

    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . The pre-dose FEV1 assessment and the individual serial FEV1 assessments at Day 168/Week 24 at the indicated time points (pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 11 hours, 12 hours, 12.5 hours, 13 hours, 14 hours, 16 hours, 20 hours, 23 hours, and 24 hour s) were summarized.

    Measured: Day 168

  2. Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1

    Time to onset of bronchodilator effect at Day 1 is defined as the actual time during the 4-hour serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) measurements that the participant first meets or exceeds a 12% and 200 mL increase over Baseline and was derived at Day 1 only. Time to onset was calculated over 0 to 4 hours (5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours) post-dose. Participants who never exceeded a 12% and 200 mL increase over Baseline were censored at the actual time of their last FEV1 measurement.

    Measured: Baseline to Day 1

  3. Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization)

    The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 1 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.

    Measured: Baseline and Randomization

  4. Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168

    The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline and Day 168 was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.

    Measured: Baseline and Day 168

  5. Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1

    The number of participants obtaining a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated at 12-hours post-dose and at 24-hours post-dose on Day 168.

    Measured: Baseline and Day 168

  6. Change From Baseline in Trough FEV1 at Day 168

    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Trough FEV1 is defined as the pre-dose measurement on Day 168/Week 24. Any missing data at Day 168/Week 24 was imputed using the last observation carried forward (LOCF). Baseline was the pre-dose measurement on Day 1. Change from Baseline was calculated as the pre-dose measurement on Day 168/Week 24 minus the Baseline value.

    Measured: Baseline and Day 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJul 2011
  4. Study completionJul 2011

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
810 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01147848
Sponsor's protocol ID
113091
Status last verified
Nov 2016
First submitted
27 May 2010
Last updated
18 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

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PubMed 36472162

  • Woodcock A, Bleecker ER, Lotvall J, O'Byrne PM, Bateman ED, Medley H, Ellsworth A, Jacques L, Busse WW. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013 Oct;144(4):1222-1229. doi: 10.1378/chest.13-0178.

    PubMed 23846316

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone furoate/Vilanterol Inhalation Powder and Fluticasone propionate/salmeterol Inhalation Powder in people with Asthma, run by GlaxoSmithKline at 63 sites in 6 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 4 inclusion and 8 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 18 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 63 sites in United States, Argentina, Netherlands, Chile, South Korea and 1 more country. 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 5 Sep 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?

Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (time frame: Baseline and Day 168/Week 24). 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 NCT01147848, which also lists 2 linked publications.

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 18 Jan 2017.

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