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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

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ClinicalTrials.gov Identifier: NCT02924688
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: FF/UMEC/VI (100/31.25/25) mcg Drug: FF/UMEC/VI (100/62.5/25) mcg Drug: FF/UMEC/VI (200/31.25/25) mcg Drug: FF/UMEC/VI (200/62.5/25) mcg 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) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2016
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : February 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: FF/UMEC/VI (100/31.25/25) mcg closed triple therapy
Subjects 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.
Drug: FF/UMEC/VI (100/31.25/25) mcg
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.

Drug: FF/VI (100/25) mcg
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.

Drug: Fluticasone/salmeterol (FSC)
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.

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

Device: ELLIPTA DPI
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.

Device: DISKUS DPI
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.

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

Experimental: FF/UMEC/VI (100/62.5/25) mcg closed triple therapy
Subjects 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.
Drug: FF/UMEC/VI (100/62.5/25) mcg
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.

Drug: FF/VI (100/25) mcg
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.

Drug: Fluticasone/salmeterol (FSC)
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.

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

Device: ELLIPTA DPI
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.

Device: DISKUS DPI
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.

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

Experimental: FF/UMEC/VI (200/31.25/25) mcg closed triple therapy
Subjects 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.
Drug: FF/UMEC/VI (200/31.25/25) mcg
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.

Drug: FF/VI (100/25) mcg
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.

Drug: Fluticasone/salmeterol (FSC)
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.

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

Device: ELLIPTA DPI
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.

Device: DISKUS DPI
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.

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

Experimental: FF/UMEC/VI (200/62.5/25) mcg closed triple therapy
Subjects 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.
Drug: FF/UMEC/VI (200/62.5/25) mcg
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.

Drug: FF/VI (100/25) mcg
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.

Drug: Fluticasone/salmeterol (FSC)
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.

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

Device: ELLIPTA DPI
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.

Device: DISKUS DPI
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.

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

Active Comparator: FF/VI (100/25) mcg dual combination therapy
Subjects 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.
Drug: FF/VI (100/25) mcg
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.

Drug: Fluticasone/salmeterol (FSC)
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.

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

Device: ELLIPTA DPI
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.

Device: DISKUS DPI
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.

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

Active Comparator: FF/VI (200/25) mcg dual combination therapy
Subjects 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.
Drug: FF/VI (100/25) mcg
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.

Drug: FF/VI (200/25) mcg
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.

Drug: Fluticasone/salmeterol (FSC)
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.

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

Device: ELLIPTA DPI
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.

Device: DISKUS DPI
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.

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




Primary Outcome Measures :
  1. Mean change from baseline in trough Forced Expiratory Volume in 1 second (FEV1) at Week 24 [ Time Frame: Baseline and Week 24 ]
    FEV1 is a measure of lung function and is defined as the maximal amount 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. Rescue medication should be withheld for at least 6 hours prior to measuring trough FEV1.


Secondary Outcome Measures :
  1. Number of on treatment moderate and/or severe asthma exacerbations [ Time Frame: Up to Week 52 ]
    Annual rate of on-treatment moderate and severe exacerbations will be compared between FF/UMEC/VI with FF/VI. Moderate exacerbation is defined as deterioration in asthma symptoms, deterioration in lung function, or increased rescue bronchodilator use lasting for at least 2 days or more and requiring a change in asthma treatment. Severe exacerbation will be defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.

  2. Mean change from baseline in clinic FEV1 at 3 hours post study treatment at Week 24 [ Time Frame: Baseline and Week 24 ]
    Post-dose FEV1 is defined as the highest FEV1 value obtained 3 hours (+/- 15 minutes) after the morning dose of investigational product. Rescue medication should be withheld for at least 6 hours prior to the pre-dose spirometry assessments until after completion of the 3 hour post-dose spirometry assessments.

  3. Mean change from baseline in Asthma Control Questionnaire-7 (ACQ-7) total score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The 7-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants will be asked to recall how their asthma had been during the previous week. Questions will be weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and <1.5 indicate partly controlled asthma, and a score >=1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.

  4. Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The SGRQ is designed to measure Quality of Life in patients with diseases of airway obstruction, measuring symptoms, impact, and activity over the past 3 months. Higher scores indicate worse health status, and a change of 4 points is considered a clinically relevant change.

  5. Mean change from baseline in Evaluating Respiratory Symptoms (E-RS) total score over Weeks 21 to 24 (inclusive) of the treatment period [ Time Frame: Baseline and Week 24 ]
    The Evaluating Respiratory Symptoms (E-RS) instrument consists of 11 items from the14 item Exacerbations of COPD patient reported outcome instrument (EXACT-PRO). The E-RS is intended to capture information related to respiratory symptoms (i.e. breathlessness, cough, sputum production, chest congestion and chest tightness). The instrument is to be completed daily each night prior to going to bed; the daily recording of information allows an assessment of the underlying day-to-day variability of a patient's symptoms. The E-RS has a scoring range of 0-40 and the responder threshold is a ≥ 2 points improvement from baseline in the total score.

  6. Incidence and type of adverse events (AE) and serious adverse event (SAE) [ Time Frame: Up to Week 52 ]
    An AE is any untoward medical occurrence in a subject, 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 or any other situation according to medical or scientific judgment will be categorized as an SAE.

  7. Electrocardiogram (ECG) measurements as a measure of safety [ Time Frame: Up to Week 52 ]
    A single 12-lead ECG will be measured in a supine position having rested in this position for approximately 5 minutes before each reading.

  8. Systolic and diastolic blood pressure assessment as a measure of safety [ Time Frame: Up to Week 52 ]
    Blood pressure will be measured in the sitting position after 5 minutes rest.

  9. Pulse rate assessment as a measure of safety [ Time Frame: Up to Week 52 ]
    Pulse rate will be measured in the sitting position after 5 minutes rest.

  10. Number of participants with abnormal clinical chemistry parameters [ Time Frame: Up to Week 52 ]
    Blood samples will be collected to analyze albumin, alkaline phosphatase, alanine aminotransferase (SGPT), aspartate amino-transferase (SGOT), direct bilirubin, total bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, blood urea nitrogen, and total serum immunoglobulin E (IgE).

  11. Number of participants with abnormal hematological parameters [ Time Frame: Up to Week 52 ]
    Blood samples will be collected to analyze hemoglobin, hematocrit, platelet count, white blood cells (WBC) count, neutrophils, basophils, eosinophils, lymphocytes, monocytes, red blood cells (RBC) count, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Screening

  • 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)
  • 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.

Exclusion Criteria for Screening

  • 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.
  • 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.

Inclusion Criteria for Enrolment

  • 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.

Exclusion Criteria for Enrolment

  • 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.

Inclusion Criteria for Randomization

  • 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.

Exclusion Criteria for Randomization

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924688


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Locations
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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35243
GSK Investigational Site
Mobile, Alabama, United States, 36608
GSK Investigational Site
Montgomery, Alabama, United States, 36106
United States, Arizona
GSK Investigational Site
Gilbert, Arizona, United States, 85234
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Encinitas, California, United States, 92024
GSK Investigational Site
Escondico, California, United States, 92025
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Huntington Beach, California, United States, 92648
GSK Investigational Site
La Jolla, California, United States, 92093
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
Los Angeles, California, United States, 90025
GSK Investigational Site
Oxnard, California, United States, 93030
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
GSK Investigational Site
Roseville, California, United States, 95661
GSK Investigational Site
San Diego, California, United States, 92103-8415
GSK Investigational Site
San Diego, California, United States, 92123
GSK Investigational Site
San Jose, California, United States, 95117
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
GSK Investigational Site
Denver, Colorado, United States, 80230
GSK Investigational Site
Lafayette, Colorado, United States, 80026
United States, Florida
GSK Investigational Site
Aventura, Florida, United States, 33180
GSK Investigational Site
Brandon, Florida, United States, 33511
GSK Investigational Site
Hollywood, Florida, United States, 33024
GSK Investigational Site
Jupiter, Florida, United States, 33458
GSK Investigational Site
Miami, Florida, United States, 33173
GSK Investigational Site
Ocoee, Florida, United States, 34761
GSK Investigational Site
Saint Petersburg, Florida, United States, 33709
GSK Investigational Site
Tallahassee, Florida, United States, 32308
United States, Georgia
GSK Investigational Site
Adairsville, Georgia, United States, 30103
GSK Investigational Site
Columbus, Georgia, United States, 31904
United States, Illinois
GSK Investigational Site
Normal, Illinois, United States, 61761
GSK Investigational Site
River Forest, Illinois, United States, 60305
United States, Indiana
GSK Investigational Site
Michigan City, Indiana, United States, 46360
GSK Investigational Site
South Bend, Indiana, United States, 46617
United States, Kansas
GSK Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40215
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
United States, Louisiana
GSK Investigational Site
Sunset, Louisiana, United States, 70584
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21236
GSK Investigational Site
Chevy Chase, Maryland, United States, 20815
GSK Investigational Site
Columbia, Maryland, United States, 21044
United States, Michigan
GSK Investigational Site
Rochester, Michigan, United States, 48307
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
United States, Missouri
GSK Investigational Site
Saint Charles, Missouri, United States, 63301
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
United States, New Jersey
GSK Investigational Site
Ocean City, New Jersey, United States, 07712
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14215-1199
GSK Investigational Site
New York, New York, United States, 10016
United States, North Carolina
GSK Investigational Site
Asheville, North Carolina, United States, 28801
GSK Investigational Site
Charlotte, North Carolina, United States, 28277
GSK Investigational Site
Gastonia, North Carolina, United States, 28054
GSK Investigational Site
High Point, North Carolina, United States, 27262
GSK Investigational Site
Huntersville, North Carolina, United States, 28078
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
GSK Investigational Site
Shelby, North Carolina, United States, 28150
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
GSK Investigational Site
Dayton, Ohio, United States, 45419
GSK Investigational Site
Dublin, Ohio, United States, 43016
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 9750420
GSK Investigational Site
Portland, Oregon, United States, 97202
GSK Investigational Site
Portland, Oregon, United States, 97223
United States, Pennsylvania
GSK Investigational Site
Jefferson Hills, Pennsylvania, United States, 15025
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site
Andreson, South Carolina, United States, 29621
GSK Investigational Site
Charleston, South Carolina, United States, 29414
GSK Investigational Site
Greenville, South Carolina, United States, 29615
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118-2040
GSK Investigational Site
Spartanburg, South Carolina, United States, 29301
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
GSK Investigational Site
Hendersonville, Tennessee, United States, 37075
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78726
GSK Investigational Site
Dallas, Texas, United States, 75225
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
El Paso, Texas, United States, 79903
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77058
GSK Investigational Site
Killeen, Texas, United States, 76542
GSK Investigational Site
Lampasas, Texas, United States, 76550
GSK Investigational Site
Live Oak, Texas, United States, 78233
GSK Investigational Site
McKinney, Texas, United States, 75069
GSK Investigational Site
Missouri City, Texas, United States, 77459
GSK Investigational Site
Pharr, Texas, United States, 78577
GSK Investigational Site
Plano, Texas, United States, 75093
GSK Investigational Site
San Antonio, Texas, United States, 78258
GSK Investigational Site
Waco, Texas, United States, 76712
United States, Virginia
GSK Investigational Site
Abingdon, Virginia, United States, 24210
GSK Investigational Site
Richmond, Virginia, United States, 23225
GSK Investigational Site
Williamsburg, Virginia, United States, 23188
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98105
Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1414AIF
GSK Investigational Site
Florida, Buenos Aires, Argentina, 1602
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
GSK Investigational Site
Paraná, Buenos Aires, Argentina, E3100BHK
GSK Investigational Site
Cordoba, Córdova, Argentina, X5003DCE
GSK Investigational Site
San Rafael, Mendoza, Argentina, 5600
GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000DBS
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000JKR
GSK Investigational Site
Berazategui, Argentina, 1886
GSK Investigational Site
Buenos Aires, Argentina, C1424BSF
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1128AAF
GSK Investigational Site
Cordoba, Argentina, 5000
GSK Investigational Site
Mendoza, Argentina, 5500
GSK Investigational Site
Mendoza, Argentina, M5500CCG
GSK Investigational Site
Santa Fe, Argentina, 3000
GSK Investigational Site
Tucuman, Argentina, 4000
Australia, New South Wales
GSK Investigational Site
Coffs Harbour, New South Wales, Australia, 2450
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
GSK Investigational Site
Sherwood, Queensland, Australia, 4075
Australia, South Australia
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
GSK Investigational Site
Clayton, Victoria, Australia, 3169
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
GSK Investigational Site
Murdoch, Western Australia, Australia, 6150
Australia
GSK Investigational Site
Golden Beach, Australia, 4551
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Ontario
GSK Investigational Site
Ajax, Ontario, Canada, L1S 2J5
GSK Investigational Site
Brampton, Ontario, Canada, L6T 0G1
GSK Investigational Site
Burlington, Ontario, Canada, L7N 3V2
GSK Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
GSK Investigational Site
London, Ontario, Canada, N5W 6A2
GSK Investigational Site
Mississauga, Ontario, Canada, L4V 1P1
GSK Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
GSK Investigational Site
Toronto, Ontario, Canada, M3J 2C5
GSK Investigational Site
Toronto, Ontario, Canada, M5T 3A9
GSK Investigational Site
Toronto, Ontario, Canada, M9V 4B4
GSK Investigational Site
Waterloo, Ontario, Canada, N2J1C4
GSK Investigational Site
Windsor, Ontario, Canada, N8X 1T3
GSK Investigational Site
Windsor, Ontario, Canada, N8X 2G1
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H4J 1C5
GSK Investigational Site
St. Charles-Borromee, Quebec, Canada, J6E 2B4
GSK Investigational Site
Trois Rivières, Quebec, Canada, G8T 7A1
GSK Investigational Site
Victoriaville, Quebec, Canada, G6P 6P6
Canada
GSK Investigational Site
Québec, Canada, G1V 4G5
Germany
GSK Investigational Site
Darmstadt, Hessen, Germany, 64283
GSK Investigational Site
Frankfurt, Hessen, Germany, 60389
GSK Investigational Site
Frankfurt, Hessen, Germany, 60596
GSK Investigational Site
Neu-Isenburg, Hessen, Germany, 63263
GSK Investigational Site
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
GSK Investigational Site
Rheine, Nordrhein-Westfalen, Germany, 48431
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
GSK Investigational Site
Leipzg, Sachsen, Germany, 04109
GSK Investigational Site
Leipzig, Sachsen, Germany, 04157
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
GSK Investigational Site
Schleswig, Schleswig-Holstein, Germany, 24837
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 10717
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 12203
GSK Investigational Site
Berlin, Germany, 13156
GSK Investigational Site
Hamburg, Germany, 22299
Italy
GSK Investigational Site
Eboli (SA), Campania, Italy, 84025
GSK Investigational Site
Parma, Emilia-Romagna, Italy, 43125
GSK Investigational Site
Roma, Lazio, Italy, 00168
GSK Investigational Site
Roma, Lazio, Italy, 00189
GSK Investigational Site
Milano, Lombardia, Italy, 20162
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Tradate (VA), Lombardia, Italy, 21049
GSK Investigational Site
Civitanova Marche (MC), Marche, Italy, 62012
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
GSK Investigational Site
Bari, Puglia, Italy, 70124
GSK Investigational Site
Palermo, Sicilia, Italy, 90146
GSK Investigational Site
Pisa, Toscana, Italy, 56124
Japan
GSK Investigational Site
Aichi, Japan, 471-8513
GSK Investigational Site
Aichi, Japan, 488-8585
GSK Investigational Site
Chiba, Japan, 278-0004
GSK Investigational Site
Fukui, Japan, 910-1193
GSK Investigational Site
Fukui, Japan, 910-8526
GSK Investigational Site
Fukuoka, Japan, 802-0052
GSK Investigational Site
Fukuoka, Japan, 805-8508
GSK Investigational Site
Fukuoka, Japan, 811-1394
GSK Investigational Site
Fukuoka, Japan, 814-0180
GSK Investigational Site
Fukuoka, Japan, 816-0813
GSK Investigational Site
Fukuoka, Japan, 832-0059
GSK Investigational Site
Gifu, Japan, 509-6134
GSK Investigational Site
Hiroshima, Japan, 720-0001
GSK Investigational Site
Hiroshima, Japan, 732-0052
GSK Investigational Site
Hiroshima, Japan, 734-8530
GSK Investigational Site
Hiroshima, Japan, 735-8585
GSK Investigational Site
Hiroshima, Japan, 737-0193
GSK Investigational Site
Hokkaido, Japan, 001-09
GSK Investigational Site
Hokkaido, Japan, 005-0841
GSK Investigational Site
Hokkaido, Japan, 006-0811
GSK Investigational Site
Hokkaido, Japan, 040-8611
GSK Investigational Site
Hokkaido, Japan, 060-0033
GSK Investigational Site
Hokkaido, Japan, 062-8618
GSK Investigational Site
Hokkaido, Japan, 064-0801
GSK Investigational Site
Hokkaido, Japan, 080-0024
GSK Investigational Site
Hyogo, Japan, 650-0047
GSK Investigational Site
Hyogo, Japan, 664-8540
GSK Investigational Site
Hyogo, Japan, 672-8064
GSK Investigational Site
Hyogo, Japan, 675-8611
GSK Investigational Site
Ibaraki, Japan, 305-8576
GSK Investigational Site
Ibaraki, Japan, 310-0015
GSK Investigational Site
Ibaraki, Japan, 311-3193
GSK Investigational Site
Ibaraki, Japan, 317-0077
GSK Investigational Site
Ibaraki, Japan, 319-1113
GSK Investigational Site
Kagawa, Japan, 761-8073
GSK Investigational Site
Kagawa, Japan, 761-8538
GSK Investigational Site
Kagawa, Japan, 762-8550
GSK Investigational Site
Kanagawa, Japan, 210-0822
GSK Investigational Site
Kanagawa, Japan, 224-8503
GSK Investigational Site
Kanagawa, Japan, 231-8682
GSK Investigational Site
Kanagawa, Japan, 232-0066
GSK Investigational Site
Kanagawa, Japan, 236-0004
GSK Investigational Site
Kanagawa, Japan, 252-0392
GSK Investigational Site
Kyoto, Japan, 607-8062
GSK Investigational Site
Kyoto, Japan, 610-0113
GSK Investigational Site
Kyoto, Japan, 612-0026
GSK Investigational Site
Kyoto, Japan, 615-8087
GSK Investigational Site
Mie, Japan, 515-8544
GSK Investigational Site
Miyagi, Japan, 983-0833
GSK Investigational Site
Miyagi, Japan, 983-8520
GSK Investigational Site
Miyagi, Japan, 984-8560
GSK Investigational Site
Miyagi, Japan, 986-8522
GSK Investigational Site
Miyagi, Japan, 989-1253
GSK Investigational Site
Nagano, Japan, 386-8610
GSK Investigational Site
Nagasaki, Japan, 850-0003
GSK Investigational Site
Nara, Japan, 632-8552
GSK Investigational Site
Oita, Japan, 874-0011
GSK Investigational Site
Okayama, Japan, 701-0304
GSK Investigational Site
Okinawa, Japan, 901-2121
GSK Investigational Site
Okinawa, Japan, 901-2214
GSK Investigational Site
Osaka, Japan, 536-0001
GSK Investigational Site
Osaka, Japan, 545-8586
GSK Investigational Site
Osaka, Japan, 550-0006
GSK Investigational Site
Osaka, Japan, 583-8588
GSK Investigational Site
Osaka, Japan, 591-8037
GSK Investigational Site
Osaka, Japan, 591-8555
GSK Investigational Site
Osaka, Japan, 593-8304
GSK Investigational Site
Osaka, Japan, 596-8501
GSK Investigational Site
Saga, Japan, 843-0393
GSK Investigational Site
Saitama, Japan, 333-0833
GSK Investigational Site
Saitama, Japan, 351-0102
GSK Investigational Site
Shimane, Japan, 690-8556
GSK Investigational Site
Shizuoka, Japan, 421-0193
GSK Investigational Site
Shizuoka, Japan, 438-8550
GSK Investigational Site
Tokyo, Japan, 103-0028
GSK Investigational Site
Tokyo, Japan, 104-8560
GSK Investigational Site
Tokyo, Japan, 105-0003
GSK Investigational Site
Tokyo, Japan, 142-8666
GSK Investigational Site
Tokyo, Japan, 145-0063
GSK Investigational Site
Tokyo, Japan, 145-0071
GSK Investigational Site
Tokyo, Japan, 157-0066
GSK Investigational Site
Tokyo, Japan, 158-0097
GSK Investigational Site
Tokyo, Japan, 164-0012
GSK Investigational Site
Tokyo, Japan, 169-0073
GSK Investigational Site
Tokyo, Japan, 171-0014
GSK Investigational Site
Tokyo, Japan, 187-0024
GSK Investigational Site
Toyama, Japan, 937-0042
GSK Investigational Site
Yamagata, Japan, 990-8533
GSK Investigational Site
Yamagata, Japan, 992-0045
GSK Investigational Site
Yamaguchi, Japan, 755-0241
GSK Investigational Site
Yamanashi, Japan, 400-0031
Korea, Republic of
GSK Investigational Site
Busan, Korea, Republic of, 602-715
GSK Investigational Site
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
GSK Investigational Site
Daegu, Korea, Republic of, 41944
GSK Investigational Site
Daegu, Korea, Republic of, 705-703
GSK Investigational Site
Daejon, Korea, Republic of, 35365
GSK Investigational Site
Gwangju, Korea, Republic of, 61469
GSK Investigational Site
Seoul, Korea, Republic of, 05505
GSK Investigational Site
Seoul, Korea, Republic of, 06591
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 130-709
GSK Investigational Site
Seoul, Korea, Republic of, 140-887
GSK Investigational Site
Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
GSK Investigational Site
Wonju-si, Kanwon-do, Korea, Republic of, 220-701
Netherlands
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Almere, Netherlands, 1311 RL
GSK Investigational Site
Beek, Netherlands, 6191 JW
GSK Investigational Site
Breda, Netherlands, 4818 CK
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Leiden, Netherlands, 2333 ZA
GSK Investigational Site
Rotterdam, Netherlands, 3051 GV
GSK Investigational Site
Rotterdam, Netherlands, 3067 GJ
GSK Investigational Site
Rotterdam, Netherlands, 3083 AN
GSK Investigational Site
Utrecht, Netherlands, 3511 NH
Poland
GSK Investigational Site
Bialystok, Poland, 15-183
GSK Investigational Site
Bydgoszcz, Poland, 85-681
GSK Investigational Site
Grudziadz, Poland, 86-300
GSK Investigational Site
Koscian, Poland, 64-000
GSK Investigational Site
Krakow, Poland, 31-209
GSK Investigational Site
Krakow, Poland, 31-637
GSK Investigational Site
Lodz, Poland, 90-302
GSK Investigational Site
Lublin, Poland, 20-089
GSK Investigational Site
Ostrowiec Swietokrzyski, Poland, 27-400
GSK Investigational Site
Poznan, Poland, 60-823
GSK Investigational Site
Rzeszow, Poland, 35-051
GSK Investigational Site
Slupsk, Poland, 76-200
GSK Investigational Site
Sopot, Poland, 81-741
GSK Investigational Site
Szczecin, Poland, 71-124
GSK Investigational Site
Tarnow, Poland, 33-100
GSK Investigational Site
Zgierz, Poland, 95-100
Romania
GSK Investigational Site
Bacau, Romania, 600114
GSK Investigational Site
Brasov, Romania, 500051
GSK Investigational Site
Brasov, Romania, 500091
GSK Investigational Site
Bucharest, Romania, 020125
GSK Investigational Site
Bucharest, Romania, 030303
GSK Investigational Site
Bucharest, Romania, 050159
GSK Investigational Site
Bucuresti, Romania, 012363
GSK Investigational Site
Bucuresti, Romania, 014452
GSK Investigational Site
Bucuresti, Romania, 040069
GSK Investigational Site
Cluj Napoca, Romania, 400015
GSK Investigational Site
Cluj Napoca, Romania, 400162
GSK Investigational Site
Cluj Napoca, Romania, 400371
GSK Investigational Site
Craiova, Romania, 200486
GSK Investigational Site
Deva, Romania, 330084
GSK Investigational Site
Galati, Romania, 800189
GSK Investigational Site
Iasi, Romania, 700115
GSK Investigational Site
Oradea, Romania, 410176
GSK Investigational Site
Pitesti, Romania, 110117
GSK Investigational Site
Slobozia, Romania, 920013
GSK Investigational Site
Suceava, Romania, 720284
GSK Investigational Site
Targu Mures, Romania, 540156
GSK Investigational Site
Timisoara, Romania, 300134
GSK Investigational Site
Timisoara, Romania, 300310
Russian Federation
GSK Investigational Site
Arkhangelsk, Russian Federation, 163000
GSK Investigational Site
Belgorod, Russian Federation, 308007
GSK Investigational Site
Blagoveshchensk, Russian Federation, 675000
GSK Investigational Site
Chelyabinsk, Russian Federation, 454006
GSK Investigational Site
Chita, Russian Federation, 672000
GSK Investigational Site
Ekaterinburg, Russian Federation, 620137
GSK Investigational Site
Irkutsk, Russian Federation, 664043
GSK Investigational Site
Ivanovo, Russian Federation, 153462
GSK Investigational Site
Izhevsk, Russian Federation, 426063
GSK Investigational Site
Kazan, Russian Federation, 420008
GSK Investigational Site
Kemerovo, Russian Federation, 650000
GSK Investigational Site
Kemerovo, Russian Federation, 650002
GSK Investigational Site
Khantymansiysk, Russian Federation, 628012
GSK Investigational Site
Krasnodar, Russian Federation, 350012
GSK Investigational Site
Krasnoyarsk, Russian Federation, 660022
GSK Investigational Site
Moscow, Russian Federation, 115 280
GSK Investigational Site
Orenburg, Russian Federation, 460040
GSK Investigational Site
Perm, Russian Federation, 614109
GSK Investigational Site
Petrozavodsk, Russian Federation, 185019
GSK Investigational Site
Saint Petersburg, Russian Federation, 197022
GSK Investigational Site
Saint-Petersburg, Russian Federation, 193231
GSK Investigational Site
Saint-Petersburg, Russian Federation, 194354
GSK Investigational Site
Saint-Petersburg, Russian Federation, 196240
GSK Investigational Site
Saint-Petersburg, Russian Federation, 198328
GSK Investigational Site
Samara, Russian Federation, 443068
GSK Investigational Site
Saratov, Russian Federation, 410028
GSK Investigational Site
Saratov, Russian Federation, 410053
GSK Investigational Site
St Petersburg, Russian Federation, 195030
GSK Investigational Site
Tomsk, Russian Federation, 634 050
GSK Investigational Site
Tomsk, Russian Federation, 634028
GSK Investigational Site
Tver, Russian Federation, 170036
GSK Investigational Site
Ufa, Russian Federation, 450071
GSK Investigational Site
Ulan-Ude, Russian Federation, 670031
GSK Investigational Site
Ulyanovsk, Russian Federation, 432063
GSK Investigational Site
Yaroslavl, Russian Federation, 150003
GSK Investigational Site
Yaroslavl, Russian Federation, 150047
South Africa
GSK Investigational Site
Middelburg, Mpumalanga, South Africa, 1055
GSK Investigational Site
Bellville, South Africa, 7530
GSK Investigational Site
Bloemfontein, South Africa, 9301
GSK Investigational Site
Cape Town, South Africa, 7764
GSK Investigational Site
Durban, South Africa, 4001
GSK Investigational Site
Mowbray, South Africa, 7700
GSK Investigational Site
Panorama, South Africa, 7500
GSK Investigational Site
Pretoria West, South Africa, 0183
GSK Investigational Site
Reiger Park, South Africa, 1459
GSK Investigational Site
Somerset West, South Africa, 7130
GSK Investigational Site
Tygerberg, South Africa, 7500
Spain
GSK Investigational Site
Alcobendas, Madrid, Spain, 28100
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08006
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Burgos, Spain, 09006
GSK Investigational Site
Centelles, Spain, 8540
GSK Investigational Site
Gerona, Spain, 17005
GSK Investigational Site
Hospitalet de Llobregat, Spain, 08907
GSK Investigational Site
Las Palmas, Spain, 35012
GSK Investigational Site
Loja/ Granada, Spain, 18300
GSK Investigational Site
Pozuelo De Alarcón/Madrid, Spain, 28223
GSK Investigational Site
Salamanca, Spain, 37007
GSK Investigational Site
Santander, Spain, 39008
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Valladolid, Spain, 47012
GSK Investigational Site
Zaragoza, Spain, 50009
United Kingdom
GSK Investigational Site
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZG
GSK Investigational Site
Romford, Essex, United Kingdom, RM1 3PJ
GSK Investigational Site
Wishaw, Lanarkshire, United Kingdom, ML2 0DP
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY3 7EN
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
GSK Investigational Site
Corby, Northamptonshire, United Kingdom, NN17 2UR
GSK Investigational Site
Bexhill, Sussex East, United Kingdom, TN40 1JJ
GSK Investigational Site
Bradford, United Kingdom, BD9 6RJ
GSK Investigational Site
Edgbaston, United Kingdom, B15 2GW
GSK Investigational Site
Liverpool., United Kingdom, L7 8XP
GSK Investigational Site
Sidcup, Kent, United Kingdom, DA14 6LT
GSK Investigational Site
Trowbridge, United Kingdom, BA14 9AR
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02924688     History of Changes
Other Study ID Numbers: 205715
2016-001304-37 ( EudraCT Number )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by GlaxoSmithKline:
umeclidinium bromide
fluticasone furoate
vilanterol
fixed dose combination
lung function
albuterol/salbutamol
asthma
closed triple therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Albuterol
Fluticasone-Salmeterol Drug Combination
Bromides
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents