AzTrials
AzTrials

AsthmaPhase 3NCT02924688

A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma

A Phase 3 study testing FF/UMEC/VI (100/31.25/25) mcg, FF/UMEC/VI (100/62.5/25) mcg and FF/UMEC/VI (200/31.25/25) mcg in people with Asthma, run by GlaxoSmithKline at 409 sites in 15 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

A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
FF/UMEC/VI (100/31.25/25) mcg, FF/UMEC/VI (100/62.5/25) mcg and FF/UMEC/VI (200/31.25/25) mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,436 participants
Where
409 sitesin 15 countries
Study dates
13 Oct 2016to 22 Feb 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 years of age or older at the time of signing the informed consent.
  • Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health at least one year prior to Visit 0.
  • Symptomatic: Subjects with inadequately controlled asthma (ACQ-6 score >=1.5) despite ICS/LABA maintenance therapy at Visit 1.
  • Asthma Control: In the 1 year prior to Visit 1
  • A documented healthcare contact for acute asthma symptoms or
  • A documented temporary change in asthma therapy for acute asthma symptoms, according to a pre-specified asthma action plan (or equivalent)
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  • Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of >250 mcg/day fluticasone proprionate [FP, or equivalent]).
  • Spirometry: A best pre-bronchodilator morning (ante meridian [AM]) FEV1 >=30% and <85% of the predicted normal value at Visit 1. Predicted values will be based upon the European Respiratory Society (ERS) Global Lung Function Initiative.
  • Reversibility of Disease: airway reversibility defined as >=12% and >=200 milliliter (mL) increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1.
  • If the subject does not meet the above reversibility criteria at Visit 1 then the reversibility assessment may be repeated once within 7 days of Visit 1 if either criteria a) or b) are met: a) >=9% increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. b) Documented evidence of a reversibility assessment within 1 year prior to Visit 1 which demonstrated a post-bronchodilator increase in FEV1 of >=12% and >=200 mL.
  • Should the subject successfully demonstrate airway reversibility (defined as >=12% and >=200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol) at the second attempt then, provided that all other eligibility criteria assessed at Visit 1 are met, the subject may enter the 3-week run-in period.
  • Short-Acting beta2 Agonists (SABAs): All subjects must be able to replace their current SABA inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Subjects must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
  • Male or eligible Female, defined as having documentation of non-reproductive potential or reproductive potential as follows:
  • A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test), not lactating, is not planning on becoming pregnant during the study and at least one of the following conditions applies: Non-reproductive potential defined as pre-menopausal females with documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile (e.g., age appropriate, >45 years, in the absence of hormone replacement therapy). In questionable cases for women <60 years of age, a blood sample with simultaneous follicle stimulating hormone and estradiol falling into the central laboratory's postmenopausal reference range is confirmatory. Females under 60 years of age, who are on hormone replacement therapy (HRT) and whose menopausal status is in doubt, are required to use a highly effective method to avoid pregnancy if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, subjects can resume use of HRT during the study without use of a highly effective method to avoid pregnancy; Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from the screening visit until after the last dose of study medication and completion of the follow-up visit. The Investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
  • Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form and in this protocol. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
  • Inadequately controlled asthma: Subjects with inadequately controlled asthma (ACQ-6 score >=1.5) at Visit 2.
  • Percent-predicted FEV1: A best pre-bronchodilator morning (AM) FEV1 >=30% and <90% of the predicted normal value at Visit 2. Predicted values will be based upon the ERS Global Lung Function Initiative
  • Liver function tests at Visit 1: alanine aminotransferase (ALT) <2 x upper limit of normal (ULN); alkaline phosphatase <=1.5xULN; bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • Compliance with completion of the Daily eDiary reporting defined as completion of all questions/assessments on >=4 of the last 7 days during the run-in period.
  • Compliance with completion of the Daily eDiary reporting defined as completion of all questions/assessments on >=4 of the last 7 days during the stabilization period.

Who cannot join

  • Pneumonia: Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
  • Asthma Exacerbation: Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1. Note: Subjects requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the subject's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification) and they are considered appropriate for enrolment into this study of up to 12 month's duration.
  • Chronic Obstructive Pulmonary Disease: Subjects with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, including history of exposure to risk factors (i.e., especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking and heating fuels) and a post-albuterol/salbutamol FEV1/Forced Vital Capacity (FVC) ratio of <0.70 and a post-albuterol/salbutamol FEV1 of =<70% of predicted normal values and onset of disease >=40 years of age.
  • Concurrent respiratory disorders: Subjects with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
  • Risk Factors for Pneumonia: Immune suppression (e.g., human immunodeficiency virus, Lupus) or other risk factors for pneumonia (e.g., neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis).
  • Patients at potentially high risk (e.g., very low body mass index (BMI), severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
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  • Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria.
  • Clinically significant Electrocardiogram abnormality: Evidence of a clinically significant abnormality in the 12-lead ECG performed during screening. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: Atrial fibrillation (AF) with rapid ventricular rate >120 Beats Per Minute (BPM); sustained or non-sustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate by Fridericia's formula (QTcF) >=500 milliseconds (msec) in subjects with QRS <120 msec and QTcF >=530 msec in subjects with QRS >=120 msec.
  • Unstable or life threatening cardiac disease: Subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure.
  • Antimuscarinic effects: Subjects with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate study participation.
  • Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment.
  • Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
  • Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 6-hour period required prior to spirometry testing at each study visit.
  • Tobacco Use: Subjects who are: Current smokers (defined as subjects who have used inhaled tobacco products within the 12 months prior to Visit 1 [i.e., cigarettes, e-cigarettes/vaping, cigars or pipe tobacco]) or former smokers with a smoking history of >=10 pack years (e.g., >=20 cigarettes/day for 10 years).
  • Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
  • Allergy or Hypersensitivity: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate.
  • Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
  • Affiliation with Investigator site: Study Investigators, sub-Investigators, study coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study.
  • Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials.
  • Respiratory Infection: Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that 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.
  • Severe asthma exacerbation: Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
  • Asthma medication: Changes in asthma medication (excluding run-in medication and albuterol/salbutamol inhalation aerosol provided at Visit 1).
  • Laboratory test abnormalities: Evidence of clinically significant abnormal laboratory tests during screening or run-in which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.
  • Respiratory Infection: Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the stabilization period that 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.
  • Severe asthma exacerbation: Evidence of a severe exacerbation during enrolment or the stabilization period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
  • Asthma medication: Changes in asthma medication (excluding stabilization period medication provided at Visit 2 and albuterol/salbutamol inhalation aerosol provided at Visit 1).

Trial locations and contacts

409 sites in 15 countries.

409 sites in 15 countries

United States99 sites

  • GSK Investigational Site

    Abingdon, Virginia, 24210

  • GSK Investigational Site

    Adairsville, Georgia, 30103

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Austin, Texas, 78726

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Birmingham, Alabama, 35243

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Buffalo, New York, 14215-1199

  • GSK Investigational Site

    Canton, California, 44718

  • GSK Investigational Site

    Charleston, South Carolina, 29414

  • GSK Investigational Site

    Charlotte, North Carolina, 28277

  • GSK Investigational Site

    Chevy Chase, Maryland, 20815

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Cincinnati, Ohio, 45242

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Columbia, Maryland, 21044

  • GSK Investigational Site

    Columbus, Georgia, 31904

  • GSK Investigational Site

    Dallas, Texas, 75225

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Dayton, Ohio, 45419

  • GSK Investigational Site

    Denver, Colorado, 80230

  • GSK Investigational Site

    Dublin, Ohio, 43016

  • GSK Investigational Site

    El Paso, Texas, 79903

  • GSK Investigational Site

    Encinitas, California, 92024

  • GSK Investigational Site

    Escondico, California, 92025

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Gilbert, Arizona, 85234

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hendersonville, Tennessee, 37075

  • GSK Investigational Site

    High Point, North Carolina, 27262

  • GSK Investigational Site

    Hollywood, Florida, 33024

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77058

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Huntington Beach, California, 92648

  • GSK Investigational Site

    Jefferson Hills, Pennsylvania, 15025

  • GSK Investigational Site

    Jupiter, Florida, 33458

  • GSK Investigational Site

    Killeen, Texas, 76542

  • GSK Investigational Site

    La Jolla, California, 92093

  • GSK Investigational Site

    Lafayette, Colorado, 80026

  • GSK Investigational Site

    Lampasas, Texas, 76550

  • GSK Investigational Site

    Lincoln, Nebraska, 68505

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Live Oak, Texas, 78233

  • GSK Investigational Site

    Long Beach, California, 90808

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Louisville, Kentucky, 40215

  • GSK Investigational Site

    McKinney, Texas, 75069

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    Michigan City, Indiana, 46360

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    Missouri City, Texas, 77459

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Montgomery, Alabama, 36106

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    Ocean City, New Jersey, 07712

  • GSK Investigational Site

    Ocoee, Florida, 34761

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Owensboro, Kentucky, 42301

  • GSK Investigational Site

    Oxnard, California, 93030

  • GSK Investigational Site

    Pharr, Texas, 78577

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • GSK Investigational Site

    Plano, Texas, 75093

  • GSK Investigational Site

    Portland, Oregon, 97202

  • GSK Investigational Site

    Portland, Oregon, 97223

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Richmond, Virginia, 23225

  • GSK Investigational Site

    River Forest, Illinois, 60305

  • GSK Investigational Site

    Rochester, Michigan, 48307

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Diego, California, 92103-8415

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    San Jose, California, 95117

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Seattle, Washington, 98115

  • GSK Investigational Site

    Shelby, North Carolina, 28150

  • GSK Investigational Site

    South Bend, Indiana, 46617

  • GSK Investigational Site

    Spartanburg, South Carolina, 29301

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St. Petersburg, Florida, 33709

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    Williamsburg, Virginia, 23188

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27104

Other trials in United States

Japan94 sites

  • GSK Investigational Site

    Aichi, 471-8513

  • GSK Investigational Site

    Aichi, 488-8585

  • GSK Investigational Site

    Chiba, 278-0004

  • GSK Investigational Site

    Fukui, 910-1193

  • GSK Investigational Site

    Fukui, 910-8526

  • GSK Investigational Site

    Fukuoka, 802-0052

  • GSK Investigational Site

    Fukuoka, 802-0083

  • GSK Investigational Site

    Fukuoka, 805-8508

  • GSK Investigational Site

    Fukuoka, 811-1394

  • GSK Investigational Site

    Fukuoka, 814-0180

  • GSK Investigational Site

    Fukuoka, 816-0813

  • GSK Investigational Site

    Fukuoka, 832-0059

  • GSK Investigational Site

    Gifu, 509-6134

  • GSK Investigational Site

    Hiroshima, 720-0001

  • GSK Investigational Site

    Hiroshima, 732-0052

  • GSK Investigational Site

    Hiroshima, 734-8530

  • GSK Investigational Site

    Hiroshima, 735-8585

  • GSK Investigational Site

    Hiroshima, 737-0193

  • GSK Investigational Site

    Hokkaido, 001-0901

  • GSK Investigational Site

    Hokkaido, 005-0841

  • GSK Investigational Site

    Hokkaido, 006-0811

  • GSK Investigational Site

    Hokkaido, 040-8611

  • GSK Investigational Site

    Hokkaido, 060-0033

  • GSK Investigational Site

    Hokkaido, 060-0061

  • GSK Investigational Site

    Hokkaido, 062-8618

  • GSK Investigational Site

    Hokkaido, 064-0801

  • GSK Investigational Site

    Hokkaido, 080-0024

  • GSK Investigational Site

    Hyōgo, 650-0047

  • GSK Investigational Site

    Hyōgo, 664-8540

  • GSK Investigational Site

    Hyōgo, 672-8064

  • GSK Investigational Site

    Hyōgo, 675-8611

  • GSK Investigational Site

    Ibaraki, 305-8576

  • GSK Investigational Site

    Ibaraki, 310-0015

  • GSK Investigational Site

    Ibaraki, 311-3193

  • GSK Investigational Site

    Ibaraki, 317-0077

  • GSK Investigational Site

    Ibaraki, 319-1113

  • GSK Investigational Site

    Kagawa, 761-8073

  • GSK Investigational Site

    Kagawa, 761-8538

  • GSK Investigational Site

    Kagawa, 762-8550

  • GSK Investigational Site

    Kanagawa, 210-0822

  • GSK Investigational Site

    Kanagawa, 224-8503

  • GSK Investigational Site

    Kanagawa, 231-8682

  • GSK Investigational Site

    Kanagawa, 232-0066

  • GSK Investigational Site

    Kanagawa, 236-0004

  • GSK Investigational Site

    Kanagawa, 252-0392

  • GSK Investigational Site

    Kyoto, 607-8062

  • GSK Investigational Site

    Kyoto, 610-0113

  • GSK Investigational Site

    Kyoto, 612-0026

  • GSK Investigational Site

    Kyoto, 615-8087

  • GSK Investigational Site

    Mie, 515-8544

  • GSK Investigational Site

    Miyagi, 983-0833

  • GSK Investigational Site

    Miyagi, 983-8520

  • GSK Investigational Site

    Miyagi, 984-8560

  • GSK Investigational Site

    Miyagi, 986-8522

  • GSK Investigational Site

    Miyagi, 989-1253

  • GSK Investigational Site

    Nagano, 386-8610

  • GSK Investigational Site

    Nagasaki, 850-0003

  • GSK Investigational Site

    Nara, 632-8552

  • GSK Investigational Site

    Ōita, 874-0011

  • GSK Investigational Site

    Okayama, 701-0304

  • GSK Investigational Site

    Okinawa, 901-2121

  • GSK Investigational Site

    Okinawa, 901-2214

  • GSK Investigational Site

    Osaka, 536-0001

  • GSK Investigational Site

    Osaka, 545-8586

  • GSK Investigational Site

    Osaka, 550-0006

  • GSK Investigational Site

    Osaka, 583-8588

  • GSK Investigational Site

    Osaka, 591-8037

  • GSK Investigational Site

    Osaka, 591-8555

  • GSK Investigational Site

    Osaka, 593-8304

  • GSK Investigational Site

    Osaka, 596-8501

  • GSK Investigational Site

    Saga, 843-0393

  • GSK Investigational Site

    Saitama, 333-0833

  • GSK Investigational Site

    Saitama, 351-0102

  • GSK Investigational Site

    Shimane, 690-8556

  • GSK Investigational Site

    Shizuoka, 421-0193

  • GSK Investigational Site

    Shizuoka, 438-8550

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 103-0028

  • GSK Investigational Site

    Tokyo, 104-8560

  • GSK Investigational Site

    Tokyo, 105-0003

  • GSK Investigational Site

    Tokyo, 142-8666

  • GSK Investigational Site

    Tokyo, 145-0063

  • GSK Investigational Site

    Tokyo, 145-0071

  • GSK Investigational Site

    Tokyo, 157-0066

  • GSK Investigational Site

    Tokyo, 158-0097

  • GSK Investigational Site

    Tokyo, 164-0012

  • GSK Investigational Site

    Tokyo, 169-0073

  • GSK Investigational Site

    Tokyo, 171-0014

  • GSK Investigational Site

    Tokyo, 187-0024

  • GSK Investigational Site

    Toyama, 937-0042

  • GSK Investigational Site

    Yamagata, 990-8533

  • GSK Investigational Site

    Yamagata, 992-0045

  • GSK Investigational Site

    Yamaguchi, 755-0241

  • GSK Investigational Site

    Yamanashi, 400-0031

Other trials in Japan

Russia36 sites

  • GSK Investigational Site

    Arkhangelsk, 163000

  • GSK Investigational Site

    Belgorod, 308007

  • GSK Investigational Site

    Blagoveshchensk, 675000

  • GSK Investigational Site

    Chelyabinsk, 454006

  • GSK Investigational Site

    Chita, 672000

  • GSK Investigational Site

    Irkutsk, 664043

  • GSK Investigational Site

    Ivanovo, 153462

  • GSK Investigational Site

    Izhevsk, 426063

  • GSK Investigational Site

    Kazan', 420008

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Khantymansiysk, 628012

  • GSK Investigational Site

    Krasnodar, 350012

  • GSK Investigational Site

    Krasnoyarsk, 660022

  • GSK Investigational Site

    Moscow, 115 280

  • GSK Investigational Site

    Orenburg, 460040

  • GSK Investigational Site

    Perm, 614109

  • GSK Investigational Site

    Petrozavodsk, 185019

  • GSK Investigational Site

    Saint Petersburg, 193231

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 195030

  • GSK Investigational Site

    Saint Petersburg, 196240

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 198328

  • GSK Investigational Site

    Samara, 443068

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    Saratov, 410053

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Tomsk, 634028

  • GSK Investigational Site

    Tver', 170036

  • GSK Investigational Site

    Ufa, 450071

  • GSK Investigational Site

    Ulan-Ude, 670031

  • GSK Investigational Site

    Ulyanovsk, 432063

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yaroslavl, 150047

  • GSK Investigational Site

    Yekaterinburg, 620137

Other trials in Russia

Romania23 sites

  • GSK Investigational Site

    Bacau, 600114

  • GSK Investigational Site

    Brasov, 500051

  • GSK Investigational Site

    Brasov, 500091

  • GSK Investigational Site

    Bucharest, 012363

  • GSK Investigational Site

    Bucharest, 014452

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 030317

  • GSK Investigational Site

    Bucharest, 040069

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Cluj-Napoca, 400015

  • GSK Investigational Site

    Cluj-Napoca, 400162

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Craiova, 200486

  • GSK Investigational Site

    Deva, 330084

  • GSK Investigational Site

    Galati, 800189

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Oradea, 410176

  • GSK Investigational Site

    Piteşti, 110117

  • GSK Investigational Site

    Slobozia, 920013

  • GSK Investigational Site

    Suceava, 720284

  • GSK Investigational Site

    Târgu Mureş, 540156

  • GSK Investigational Site

    Timișoara, 300134

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

Argentina19 sites

  • GSK Investigational Site

    Berazategui, 1884

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Buenos Aires, C1128AAF

  • GSK Investigational Site

    Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5003DCE

  • GSK Investigational Site

    Córdoba, 5000

  • GSK Investigational Site

    Florida, Buenos Aires, 1602

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    Paraná, Buenos Aires, E3100BHK

  • GSK Investigational Site

    Rosario, Santa Fe Province, 2000

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000DBS

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000JKR

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    San Rafael, Mendoza Province, 5600

  • GSK Investigational Site

    Santa Fe, 3000

Other trials in Argentina

Canada19 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Hamilton, Ontario, L8L 5G8

  • GSK Investigational Site

    London, Ontario, N5W 6A2

  • GSK Investigational Site

    Mississauga, Ontario, L4V 1P1

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Québec, G1V 4G5

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1A 3R5

  • GSK Investigational Site

    Toronto, Ontario, M3J 2C5

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Toronto, Ontario, M9V 4B4

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Victoriaville, Quebec, G6P 6P6

  • GSK Investigational Site

    Waterloo, Ontario, N2J1C4

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3

  • GSK Investigational Site

    Windsor, Ontario, N8X 2G1

Other trials in Canada

Germany18 sites

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Berlin, 13156

  • GSK Investigational Site

    Darmstadt, Hesse, 64283

  • 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

    Gelsenkirchen, North Rhine-Westphalia, 45879

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04157

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Rheine, North Rhine-Westphalia, 48431

  • GSK Investigational Site

    Schleswig, Schleswig-Holstein, 24837

Other trials in Germany

Spain17 sites

  • GSK Investigational Site

    Alcobendas, Madrid, 28100

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08006

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Burgos, 09006

  • GSK Investigational Site

    Centelles, 8540

  • GSK Investigational Site

    Girona, 17005

  • GSK Investigational Site

    L'Hospitalet de Llobregat, 08907

  • GSK Investigational Site

    Las Palmas, 35012

  • GSK Investigational Site

    Loja/ Granada, 18300

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    Salamanca, 37007

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valladolid, 47012

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Poland16 sites

  • GSK Investigational Site

    Bialystok, 15-183

  • GSK Investigational Site

    Bydgoszcz, 85-681

  • GSK Investigational Site

    Grudziądz, 86-300

  • GSK Investigational Site

    Kościan, 64-000

  • GSK Investigational Site

    Krakow, 31-209

  • GSK Investigational Site

    Krakow, 31-637

  • GSK Investigational Site

    Lodz, 90-302

  • GSK Investigational Site

    Lublin, 20-089

  • GSK Investigational Site

    Ostrowiec Świętokrzyski, 27-400

  • GSK Investigational Site

    Poznan, 60-823

  • GSK Investigational Site

    Rzeszów, 35-051

  • GSK Investigational Site

    Słupsk, 76-200

  • GSK Investigational Site

    Sopot, 81-741

  • GSK Investigational Site

    Szczecin, 71-124

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Zgierz, 95-100

Other trials in Poland

South Korea13 sites

  • GSK Investigational Site

    Busan, 602-715

  • GSK Investigational Site

    Cheongju-si, Chungcheongbuk-do, 28644

  • GSK Investigational Site

    Daegu, 41944

  • GSK Investigational Site

    Daegu, 705-703

  • GSK Investigational Site

    Daejeon, 35365

  • GSK Investigational Site

    Gwangju, 61469

  • GSK Investigational Site

    Seoul, 05505

  • GSK Investigational Site

    Seoul, 06591

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 130-709

  • GSK Investigational Site

    Seoul, 140-887

  • GSK Investigational Site

    Suwon-si, Gyeonggi-do, 443-380

  • GSK Investigational Site

    Wonju-si, Kanwon-do, 220-701

Other trials in South Korea

Italy12 sites

  • GSK Investigational Site

    Bari, Apulia, 70124

  • GSK Investigational Site

    Civitanova Marche (MC), The Marches, 62012

  • GSK Investigational Site

    Eboli (SA), Campania, 84025

  • GSK Investigational Site

    Milan, Lombardy, 20162

  • GSK Investigational Site

    Orbassano (TO), Piedmont, 10043

  • GSK Investigational Site

    Palermo, Sicily, 90146

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43125

  • GSK Investigational Site

    Pavia, Lombardy, 27100

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Rome, Lazio, 00168

  • GSK Investigational Site

    Rome, Lazio, 00189

  • GSK Investigational Site

    Tradate (VA), Lombardy, 21049

Other trials in Italy

United Kingdom12 sites

  • GSK Investigational Site

    Aberdeen, Aberdeenshire, AB25 2ZG

  • GSK Investigational Site

    Bexhill-on-Sea, Sussex East, TN40 1JJ

  • GSK Investigational Site

    Blackpool, Lancashire, FY3 7EN

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    Corby, Northamptonshire, NN17 2UR

  • GSK Investigational Site

    Edgbaston, B15 2GW

  • GSK Investigational Site

    Liverpool, L7 8XP

  • GSK Investigational Site

    Northwood, Middlesex, HA6 2RN

  • GSK Investigational Site

    Romford, Essex, RM1 3PJ

  • GSK Investigational Site

    Sidcup, Kent, DA14 6LT

  • GSK Investigational Site

    Trowbridge, BA14 9AR

  • GSK Investigational Site

    Wishaw, Lanarkshire, ML2 0DP

Other trials in United Kingdom

Netherlands11 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Almere Stad, 1311 RL

  • GSK Investigational Site

    Beek, 6191 JW

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Hengelo, 7555 DL

  • GSK Investigational Site

    Leiden, 2333 ZA

  • GSK Investigational Site

    Rotterdam, 3051 GV

  • GSK Investigational Site

    Rotterdam, 3067 GJ

  • GSK Investigational Site

    Rotterdam, 3083 AN

  • GSK Investigational Site

    Utrecht, 3511 NH

Other trials in Netherlands

South Africa11 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7764

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Middelburg, Mpumalanga, 1055

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Panorama, 7500

  • GSK Investigational Site

    Pretoria West, 0183

  • GSK Investigational Site

    Reiger Park, 1459

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Tygerberg, 7500

Other trials in South Africa

Australia9 sites

  • GSK Investigational Site

    Bedford Park, South Australia, 5042

  • GSK Investigational Site

    Clayton, Victoria, 3169

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Golden Beach, 4551

  • GSK Investigational Site

    Melbourne, Victoria, 3004

  • GSK Investigational Site

    Murdoch, Western Australia, 6150

  • GSK Investigational Site

    Randwick, New South Wales, 2031

  • GSK Investigational Site

    Sherwood, Queensland, 4075

  • GSK Investigational Site

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powder Inhaler in Subjects With Inadequately Controlled Asthma

A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. This is a phase III, multi-center, active-controlled, double-blind, parallel-group study to compare the efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This study has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization, Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all protocol defined inclusion/exclusion criteria will enter a 3-week run-in period and will receive fixed dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) (fluticasone/salmeterol, 250/50 micrograms (mcg), via the DISKUS® DPI) one inhalation twice a day. At Visit 2 (Enrolment), eligible subjects will be enrolled into the 2-week stabilization period to receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the morning). At the conclusion of the stabilization period (Visit 3), all subjects who meet the pre-defined randomization criteria will be randomized 1:1:1:1:1:1 during the treatment period to receive either FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg; 200/31.25/25 mcg) or FF/VI (100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the morning. The duration of the treatment period is variable but will be a minimum of 24 weeks and a maximum of 52 weeks. Subjects will have up to 6 on-treatment clinic visits scheduled at Visits 3, 4, 5, 6, 7 and 8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52, respectively). A follow-up visit will be conducted approximately 7 days after the end of treatment period or, if applicable, after the early withdrawal visit. Subjects will be provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study. Approximately 2250 subjects will be randomized, with approximately 375 subjects randomized to each of the 6 double-blind treatment arms to ensure approximately 337 evaluable subjects per treatment arm. DISKUS and ELLIPTA are registered trademarks of GSK groups of companies.

Conditions
Asthma
Being tested
FF/UMEC/VI (100/31.25/25) mcg, FF/UMEC/VI (100/62.5/25) mcg, FF/UMEC/VI (200/31.25/25) mcg, FF/UMEC/VI (200/62.5/25) mcg, FF/VI (100/25) mcg
Keywords
umeclidinium bromide, fluticasone furoate, vilanterol, fixed dose combination, lung function, albuterol/salbutamol, asthma, closed triple therapy
Medical subject headings
Asthma

What participants receive

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

  • FF/UMEC/VI (100/31.25/25) mcgDrug

    Dry white powder delivered via the ELLIPTA DPI (one inhalation once-daily [QD] in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.

  • FF/UMEC/VI (100/62.5/25) mcgDrug

    Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.

  • FF/UMEC/VI (200/31.25/25) mcgDrug

    Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.

  • FF/UMEC/VI (200/62.5/25) mcgDrug

    Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.

  • FF/VI (100/25) mcgDrug

    Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains VI 25 mcg in each blister.

  • FF/VI (200/25) mcgDrug

    Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains VI 25 mcg in each blister.

  • Fluticasone/salmeterol (FSC)Drug

    Dry white powder delivered via the DISKUS DPI (one inhalation twice daily: one in the morning and one in the evening). The DISKUS DPI holds a strip of 60 blisters; each blister contains FP 250 mcg and 50 mcg of salmeterol.

  • Albuterol/salbutamolDrug

    This is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.

  • ELLIPTA DPIDevice

    The ELLIPTA device will be used during the stabilization period and the treatment period. The ELLIPTA DPI is a moulded plastic two-sided device that can hold two individual blister strips which contain powder formulation for oral inhalation.

  • DISKUS DPIDevice

    The DISKUS device will be used during the run-in period. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FSC for oral inhalation.

  • METERED-DOSE INHALER (MDI)Device

    Albuterol/salbutamol (rescue medication) will be delivered via metered-dose inhaler (MDI) will be used for reversibility testing.

Study groups in NCT02924688
Study groupRoleWhat they receive
FF/UMEC/VI (100/31.25/25) mcg closed triple therapyExperimentalSubjects will receive FF/UMEC/VI (100/31.25/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
Receives: Drug: FF/UMEC/VI (100/31.25/25) mcg; Drug: FF/VI (100/25) mcg; Drug: Fluticasone/salmeterol (FSC); Drug: Albuterol/salbutamol; Device: ELLIPTA DPI; Device: DISKUS DPI; Device: METERED-DOSE INHALER (MDI)
FF/UMEC/VI (100/62.5/25) mcg closed triple therapyExperimentalSubjects will receive FF/UMEC/VI (100/62.5/25) mcg inhalation powder via DPI, once daily in the morning. Subjects will also receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
Receives: Drug: FF/UMEC/VI (100/62.5/25) mcg; Drug: FF/VI (100/25) mcg; Drug: Fluticasone/salmeterol (FSC); Drug: Albuterol/salbutamol; Device: ELLIPTA DPI; Device: DISKUS DPI; Device: METERED-DOSE INHALER (MDI)
FF/UMEC/VI (200/31.25/25) mcg closed triple therapyExperimentalSubjects will receive FF/UMEC/VI (200/31.25/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
Receives: Drug: FF/UMEC/VI (200/31.25/25) mcg; Drug: FF/VI (100/25) mcg; Drug: Fluticasone/salmeterol (FSC); Drug: Albuterol/salbutamol; Device: ELLIPTA DPI; Device: DISKUS DPI; Device: METERED-DOSE INHALER (MDI)
FF/UMEC/VI (200/62.5/25) mcg closed triple therapyExperimentalSubjects may receive FF/UMEC/VI (200/62.5/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
Receives: Drug: FF/UMEC/VI (200/62.5/25) mcg; Drug: FF/VI (100/25) mcg; Drug: Fluticasone/salmeterol (FSC); Drug: Albuterol/salbutamol; Device: ELLIPTA DPI; Device: DISKUS DPI; Device: METERED-DOSE INHALER (MDI)
FF/VI (100/25) mcg dual combination therapyActive comparatorSubjects will receive FF/VI (100/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
Receives: Drug: FF/VI (100/25) mcg; Drug: Fluticasone/salmeterol (FSC); Drug: Albuterol/salbutamol; Device: ELLIPTA DPI; Device: DISKUS DPI; Device: METERED-DOSE INHALER (MDI)
FF/VI (200/25) mcg dual combination therapyActive comparatorSubjects will receive FF/VI (200/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
Receives: Drug: FF/VI (100/25) mcg; Drug: FF/VI (200/25) mcg; Drug: Fluticasone/salmeterol (FSC); Drug: Albuterol/salbutamol; Device: ELLIPTA DPI; Device: DISKUS DPI; Device: METERED-DOSE INHALER (MDI)

What is being measured

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

  1. Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24

    FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Treatment policy estimand was assessed, including all on- and post-treatment data. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement. Mixed Model Repeated Measures(MMRM) was used.

    Measured: Baseline (pre-dose at Day 1) and Week 24

Secondary outcomes (11)

  1. Annualized Rate of Moderate and Severe Asthma Exacerbations

    A moderate asthma exacerbation is considered to be a deterioration in asthma symptoms or in lung function, or increased rescue bronchodilator use lasting for at least 2 days or more, but not be severe enough to warrant systemic corticosteroid use (or a doubling or more of the maintenance systemic corticosteroid dose, if applicable) for 3 days or more and/or hospitalization. It is an event that, when recognized, should result in a temporary change in treatment, to prevent it from becoming severe. A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets,suspension or injection), or an increase from a stable maintenance dose (For participants receiving maintenance systemic corticosteroids, at least double the maintenance systemic corticosteroid dose for at least 3 days is required), for at least 3 days or an inpatient hospitalization or emergency department visit because of asthma, requiring systemic corticosteroids.

    Measured: Up to Week 52

  2. Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24

    FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 (recorded at 3 hours post dose) minus the Baseline value.

    Measured: Baseline (pre-dose at Day 1) and 3 hours post dose at Week 24

  3. Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24

    The ACQ-7 consists of 7 attributes of asthma control, of which 6 to be self-completed by participant in a 6-item questionnaire, enquire about frequency and/or severity of symptoms over the previous week on: nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, wheeze, and rescue medication use. The seventh attribute measures the lung function, which was included via pre-bronchodilator FEV1 % predicted value. All 7 items of ACQ have response on 0-6 ordinal scale (0=no impairment/limitation, 6=total impairment/limitation). The total score is calculated as the average of all non-missing item responses, ranges from 0 to 6. Higher score indicates worst symptoms. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was at randomization visit (pre-dose,Day 1). Change from Baseline was defined as value at Week 24 minus Baseline value.

    Measured: Baseline (pre-dose at Day 1) and Week 24

  4. Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24

    The SGRQ had 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure quality of life (QoL) of participants with airway obstruction, measuring symptoms, impact, and activity. The questions are designed to be self-completed by the participant with a recall over the past 3 months. SGRQ total score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100. SGRQ total score ranges from 0 to 100 where 0 indicates best and 100 indicates worst health. A change of 4 points is considered a clinically relevant change. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was at randomization visit (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value.

    Measured: Baseline (pre-dose at Day 1) and Week 24

  5. Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period

    The E-RS in Chronic Obstructive Pulmonary Disease (COPD) consists of 11 items. E-RS captures information related to respiratory symptoms, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS was completed daily and data was derived by 4-weekly intervals, requiring at least 50% of data to be present during a period. 7 items are scored from 0 (not at all) to 4 (extreme) and 4 items are scored from 0 (not at all) to 3 (extreme). The E-RS total score was calculated by taking sum of all the items. The E-RS total score has a scoring range of 0 to 40, with higher scores indicating more severe respiratory symptoms. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was the mean value of 14 days prior to randomization. Change from Baseline was calculated as post-baseline value (mean of daily E-RS total scores during Week 21 to 24 ) minus Baseline value.

    Measured: Baseline (14 days prior to randomization) and Weeks 21 to 24

  6. Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE

    Adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAE and common (>=3%) non-SAEs are presented.

    Measured: Up to Week 52

  7. Number of Participants With Abnormal Electrocardiogram (ECG) Findings

    Twelve-lead ECGs were performed during the study using an automated ECG machine. All ECG measurements were made with the participant in a supine position having rested in this position for approximately 5 minutes before each reading. The number of participants with worst case post-Baseline abnormal ECG findings were reported.

    Measured: Up to Week 52

  8. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24

    Blood pressure (systolic and diastolic) was measured in the sitting position after approximately 5 minutes rest. Baseline value is the last acceptable/borderline acceptable value prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at the clinic visit minus the Baseline value. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement.

    Measured: Baseline (pre-dose at Day 1) and Week 24

  9. Mean Change From Baseline in Pulse Rate at Week 24

    Pulse Rate was measured in the sitting position after approximately 5 minutes rest. Baseline value is the last acceptable/borderline acceptable value prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at the clinic visit minus the Baseline value. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement.

    Measured: Baseline (pre-dose at Day 1) and Week 24

  10. Number of Participants With Abnormal Clinical Chemistry Values

    Blood samples were collected for assessment of clinical chemistry parameters, which included albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, total bilirubin, calcium, creatinine, glucose, potassium, protein, sodium and urea. Abnormal laboratory results are categorized as high or low with respect to their normal ranges. Participants having High and Low values from normal ranges for any parameter at any time post-baseline visits are presented.

    Measured: Up to Week 52

  11. Number of Participants With Abnormal Hematology Values

    Blood samples were collected for assessment of hematology parameters, which included Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Platelets, Mean Corpuscular Hemoglobin (MCH) and Mean Corpuscular Volume (MCV). Abnormal laboratory results are categorized as high or low with respect to their normal ranges. Participants having High and Low values from normal ranges for any parameter at any time post-baseline visits are presented.

    Measured: Up to Week 52

Timeline

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

  1. First posted5 Oct 2016 (estimated)
  2. Study start13 Oct 2016
  3. Primary completion22 Feb 2019
  4. Study completion22 Feb 2019

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,436 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02924688
Sponsor's protocol ID
205715
Other IDs
2016-001304-37, 2016
Status last verified
Feb 2021
First submitted
12 Sep 2016
Last updated
26 Mar 2021
Data monitoring committee
No
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site.

Publications

  • Oppenheimer J, Pavord ID, Corbridge T, Crawford J, Gould S, Hamouda M, Howarth P, Burrows E, Moore A, Noorduyn SG, Slade D, Weng S, Lugogo N. Evaluating Asthma Clinical Remission with Inhaled Therapy: Post Hoc Analyses of CAPTAIN. Adv Ther. 2026 Feb;43(2):729-749. doi: 10.1007/s12325-025-03442-x. Epub 2025 Dec 24.

    PubMed 41442024

  • Boulet LP, Abbott C, Brusselle G, Edwards D, Oppenheimer J, Pavord ID, Pizzichini E, Sagara H, Slade D, Wechsler ME, Gibson PG. Baseline Characteristics and ICS/LAMA/LABA Response in Asthma: Analyses From the CAPTAIN Study. J Allergy Clin Immunol Pract. 2024 May;12(5):1244-1253.e8. doi: 10.1016/j.jaip.2024.01.039. Epub 2024 Feb 1.

    PubMed 38309696

  • Oppenheimer J, Hanania NA, Chaudhuri R, Sagara H, Bailes Z, Fowler A, Peachey G, Pizzichini E, Slade D. Clinic vs Home Spirometry for Monitoring Lung Function in Patients With Asthma. Chest. 2023 Nov;164(5):1087-1096. doi: 10.1016/j.chest.2023.06.029. Epub 2023 Jun 27.

    PubMed 37385337

  • 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

  • Nakamura Y, Hozawa S, Sagara H, Ohbayashi H, Lee LA, Crawford J, Tamaoki J, Nishi T, Fowler A. Efficacy and safety of once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol in Japanese patients with inadequately controlled asthma: the CAPTAIN study. Curr Med Res Opin. 2021 Sep;37(9):1657-1665. doi: 10.1080/03007995.2021.1944849. Epub 2021 Jul 14.

    PubMed 34162298

  • Yang S, Lee LA, Sule N, Fowler A, Peachey G. Population Pharmacokinetic Modeling of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol in Patients with Asthma, Using Data from a Phase IIIA Study (CAPTAIN). Clin Pharmacokinet. 2021 Jul;60(7):887-896. doi: 10.1007/s40262-021-00988-1. Epub 2021 Feb 18.

    PubMed 33598874

  • Lee LA, Bailes Z, Barnes N, Boulet LP, Edwards D, Fowler A, Hanania NA, Kerstjens HAM, Kerwin E, Nathan R, Oppenheimer J, Papi A, Pascoe S, Brusselle G, Peachey G, Sule N, Tabberer M, Pavord ID. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. Lancet Respir Med. 2021 Jan;9(1):69-84. doi: 10.1016/S2213-2600(20)30389-1. Epub 2020 Sep 9.

    PubMed 32918892

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FF/UMEC/VI (100/31.25/25) mcg, FF/UMEC/VI (100/62.5/25) mcg and FF/UMEC/VI (200/31.25/25) mcg in people with Asthma, run by GlaxoSmithKline at 409 sites in 15 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 27 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 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 409 sites in United States, Japan, Russia, Romania, Argentina and 10 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 21 Feb 2020). 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 in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (time frame: Baseline (pre-dose at Day 1) and 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 NCT02924688, which also lists 7 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 26 Mar 2021.

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