AzTrials
AzTrials

AsthmaPhase 3NCT02301975

An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma

A Phase 3 study testing Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler, Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler and Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler in people with Asthma, run by GlaxoSmithKline at 179 sites in 12 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

This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate… 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 100/25 mcg via ELLIPTA inhaler, Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler and Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,526 participants
Where
179 sitesin 12 countries
Study dates
1 Mar 2015to 25 Nov 2016
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

  • Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities.
  • Subjects must be outpatients >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects >=18 years of age only).
  • Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly.
  • Subjects must have a FEV1 of >=80% of the predicted normal value.
  • Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1.
  • All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol 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 6 hours prior to study visits.
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  • If in the opinion of the investigator the subject's asthma is well controlled. Exclusion Criteria
  • History of Life-Threatening Asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years.
  • 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, expected to affect the subject's asthma status or the subject's ability to participate in the study.
  • Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
  • A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma
  • A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
  • A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study, whichever is longer of the two.
  • 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 RELVAR™ ELLIPTA inhaler, SERETIDE™ ACCUHALER/DISKUS inhaler or FP 250.
  • History of severe milk protein allergy.
  • Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug.
  • A subject must not be using or require the use of immunosuppressive medications during the study.
  • 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.
  • Current tobacco smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products or inhaled marijuana within the past 3 months (e.g., cigarettes, cigars, electronic cigarettes, or pipe tobacco).
  • 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.

Who cannot join

None listed.

Trial locations and contacts

179 sites in 12 countries.

179 sites in 12 countries

United States34 sites

  • GSK Investigational Site

    Albany, Georgia, 31707

  • GSK Investigational Site

    Austin, Texas, 78750

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Bellevue, Nebraska, 68123-4303

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18020

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Charlotte, North Carolina, 28277

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Columbia, Maryland, 21044

  • GSK Investigational Site

    Columbia, Missouri, 65203

  • GSK Investigational Site

    Denver, Colorado, 80230

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Greenfield, Wisconsin, 53228

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hendersonville, North Carolina, 28739

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Lewisville, Texas, 75067

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33165

  • GSK Investigational Site

    Miami, Florida, 33174

  • GSK Investigational Site

    Middleburg Heights, Ohio, 44130

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Plymouth, Minnesota, 55441

  • GSK Investigational Site

    Richmond, Virginia, 23225

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Rolla, Missouri, 65401

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Upland, California, 91786

  • GSK Investigational Site

    Waco, Texas, 76712

Other trials in United States

Germany34 sites

  • GSK Investigational Site

    Bamberg, Bavaria, 96049

  • GSK Investigational Site

    Berlin, 10119

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 10969

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Berlin, 13156

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45355

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04207

  • GSK Investigational Site

    Leipzig, Saxony, 04275

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Marburg, Hesse, 35037

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Munich, Bavaria, 80539

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Peine, Lower Saxony, 31224

  • GSK Investigational Site

    Potsdam, Brandenburg, 14469

  • GSK Investigational Site

    Schleswig, Schleswig-Holstein, 24837

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70378

  • GSK Investigational Site

    Teuchern, Saxony-Anhalt, 6682

  • GSK Investigational Site

    Warendorf, North Rhine-Westphalia, 48231

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58452

Other trials in Germany

Russia26 sites

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Blagoveshchensk, 675000

  • GSK Investigational Site

    Irkutsk, 664043

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Krasnodar, 350012

  • GSK Investigational Site

    Moscow, 115201

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Moscow, 123 182

  • GSK Investigational Site

    Moscow, 125315

  • GSK Investigational Site

    Omsk, 644112

  • GSK Investigational Site

    Pyatigorsk, 357538

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 194356

  • GSK Investigational Site

    Saint Petersburg, 196240

  • GSK Investigational Site

    Saint Petesburg, 195030

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    St'Petersburg, 197706

  • GSK Investigational Site

    Stavropol, 355017

  • GSK Investigational Site

    Tomsk, 634009

  • GSK Investigational Site

    Tomsk, 634033

  • GSK Investigational Site

    Ufa, 450071

  • GSK Investigational Site

    Ulyanovsk, 432063

  • GSK Investigational Site

    Vladimir, 600023

  • GSK Investigational Site

    Volgodonsk, 347381

  • GSK Investigational Site

    Voronezh, 394018

Other trials in Russia

Argentina14 sites

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Florida, Buenos Aires, 1602

  • GSK Investigational Site

    La Plata, Buenos Aires, 1900

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Mar del Plata, B7600FYK

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    Quilmes, Buenos Aires, B1878FNR

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000DBS

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000JKR

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Romania14 sites

  • GSK Investigational Site

    Bacau, 600114

  • GSK Investigational Site

    Bacau, 600252

  • GSK Investigational Site

    Brasov, 500112

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 022102

  • GSK Investigational Site

    Bucharest, 030317

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Codlea, 505100

  • GSK Investigational Site

    Craiova, 200345

  • GSK Investigational Site

    Deva, 330182

  • GSK Investigational Site

    Piteşti, 110084

  • GSK Investigational Site

    Suceava, 720284

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

Czechia11 sites

  • GSK Investigational Site

    Česká Lípa, 470 01

  • GSK Investigational Site

    Hlučín, 748 01

  • GSK Investigational Site

    Hradec Králové, 500 02

  • GSK Investigational Site

    Kutná Hora, 284 01

  • GSK Investigational Site

    Lovosice, 410 02

  • GSK Investigational Site

    Olomouc, 772 00

  • GSK Investigational Site

    Ostrava - Poruba, 70868

  • GSK Investigational Site

    Rokycany, 337 01

  • GSK Investigational Site

    Tábor, 390 01

  • GSK Investigational Site

    Teplice, 415 10

  • GSK Investigational Site

    Varnsdorf, 407 47

Other trials in Czechia

Netherlands11 sites

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Almere Stad, 1311 RL

  • GSK Investigational Site

    Almere Stad, 1315 RC

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Breda, 4819 EV

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Kloosterhaar, 7694 AC

  • GSK Investigational Site

    Nijverdal, 7442 LS

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

Spain11 sites

  • GSK Investigational Site

    Alicante, 03004

  • GSK Investigational Site

    Alzira/Valencia, 46600

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08016

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Centelles (Barcelona), 08540

  • GSK Investigational Site

    Madrid, 28009

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46015

Other trials in Spain

Chile7 sites

  • GSK Investigational Site

    Concepción, Región Del Biobio, 4070038

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500692

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500710

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7510186

  • GSK Investigational Site

    Santiago, 7500698

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

  • GSK Investigational Site

    Viña del Mar, 2520594

Other trials in Chile

Mexico6 sites

  • GSK Investigational Site

    Mexico City, 01710

  • GSK Investigational Site

    Monterrey NL, Nuevo León, 64718

  • GSK Investigational Site

    Morelia, Michoacán, 58070

  • GSK Investigational Site

    Villahermosa, Tabasco, 86035

  • GSK Investigational Site

    Zapopan, Jalisco, 45030

  • GSK Investigational Site

    Zapopan, Jalisco, 45070

Other trials in Mexico

South Korea6 sites

  • GSK Investigational Site

    Cheongju-si, Chungcheongbuk-do, 361-763

  • GSK Investigational Site

    Incheon, 403-720

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Suwon-si, Gyeonggi-do, 16499

Other trials in South Korea

Brazil5 sites

  • GSK Investigational Site

    Goiânia, Goiás, 74110 030

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • GSK Investigational Site

    Salvador, Estado de Bahia, 41940455

  • GSK Investigational Site

    São Paulo, 01323903

  • GSK Investigational Site

    São Paulo, 04266-010

Other trials in Brazil

About this study

Official title: A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist

This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice daily [BD]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.

SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.

Conditions
Asthma
Being tested
Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler, Placebo inhalation powders via ELLIPTA inhaler, Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler, Placebo inhalation powder via ACCUHALER/DISKUS inhaler, Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler
Keywords
Adult, asthma, Fluticasone Propionate, Adolescents, Salmeterol, Vilanterol, ELLIPTA, ACCUHALER/DISKUS, Non-inferior, Fluticasone Furoate
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 100/25 mcg via ELLIPTA inhalerDrug

    FF/Vilanterol 100/25 mcg inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device and 100/25 mcg per actuation.

  • Placebo inhalation powders via ELLIPTA inhalerDrug

    Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device.

  • Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhalerDrug

    FP/Salmeterol 250/50 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250/50 mcg per actuation.

  • Placebo inhalation powder via ACCUHALER/DISKUS inhalerDrug

    Placebo inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device.

  • Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhalerDrug

    FP 250 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250 mcg per actuation.

Study groups in NCT02301975
Study groupRoleWhat they receive
Fluticasone Furoate/Vilanterol 100/25 mcgExperimentalFF/VI 100/25 mcg by inhalation OD (PM) via ELLIPTA plus placebo by inhalation BD (AM and PM) via ACCUHALER/DISKUS for 24 weeks.
Receives: Drug: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler; Drug: Placebo inhalation powder via ACCUHALER/DISKUS inhaler
Fluticasone Propionate/Salmeterol 250/50 mcgExperimentalFP/Salmeterol 250/50 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.
Receives: Drug: Placebo inhalation powders via ELLIPTA inhaler; Drug: Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler
Fluticasone Propionate 250 mcgExperimentalFP 250 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.
Receives: Drug: Placebo inhalation powders via ELLIPTA inhaler; Drug: Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler

What is being measured

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

  1. Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population

    FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication.

    Measured: Baseline and Week 24

  2. Change From Baseline in PM FEV1 Using Per Protocol (PP) Population

    FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations.

    Measured: Baseline and Week 24

Secondary outcomes (5)

  1. Change From Baseline in the Percentage of Rescue-free 24-hour Periods

    The number of inhalations of rescue medication used during the day and night were recorded by participants using an electronic diary (e-diary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.

    Measured: Baseline and Weeks 1-24

  2. Change From Baseline in the Percentage of Symptom-free 24-hour Periods

    Change from Baseline in the percentage of symptom-free 24 hour period was evaluated. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value.Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.

    Measured: Baseline and Weeks 1-24

  3. Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF)

    PEF was measured using an electric flow meter each morning. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.

    Measured: Baseline and Weeks 1-24

  4. Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20

    The ACT was a five-item questionnaire developed as a measure of participant's asthma control. The percentage of participants controlled, defined as having ACT score greater than or equal to 20 at the end of Week 24 were analyzed using logistic regression model with covariates of Baseline ACT score, region, sex, age and treatment group.

    Measured: Week 24

  5. Change From Baseline in PM PEF

    PEF was measured using an electric flow meter each evening. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.

    Measured: Baseline and Weeks 1-24

Timeline

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

  1. First posted26 Nov 2014 (estimated)
  2. Study start1 Mar 2015
  3. Primary completion1 Nov 2016
  4. Study completion25 Nov 2016

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
1,526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02301975
Sponsor's protocol ID
201378
Status last verified
Aug 2018
First submitted
24 Nov 2014
Last updated
6 Aug 2018
Data monitoring committee
No

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

  • Bernstein D, Andersen L, Forth R, Jacques L, Yates L. Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA. J Asthma. 2018 Sep;55(9):984-993. doi: 10.1080/02770903.2017.1386214. Epub 2018 Apr 13.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler, Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler and Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler in people with Asthma, run by GlaxoSmithKline at 179 sites in 12 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 20 inclusion and 0 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 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States, Germany, Russia, Argentina, Romania and 7 more countries. 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 12 Jun 2017). 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 Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. 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 NCT02301975, 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 6 Aug 2018.

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