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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02924688




Registration number
NCT02924688
Ethics application status
Date submitted
12/09/2016
Date registered
5/10/2016
Date last updated
26/03/2021

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2016-001304-37
Secondary ID [2] 0 0
205715
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FF/UMEC/VI (100/31.25/25) mcg
Treatment: Drugs - FF/UMEC/VI (100/62.5/25) mcg
Treatment: Drugs - FF/UMEC/VI (200/31.25/25) mcg
Treatment: Drugs - FF/UMEC/VI (200/62.5/25) mcg
Treatment: Drugs - FF/VI (100/25) mcg
Treatment: Drugs - FF/VI (200/25) mcg
Treatment: Drugs - Fluticasone/salmeterol (FSC)
Treatment: Drugs - Albuterol/salbutamol
Treatment: Devices - ELLIPTA DPI
Treatment: Devices - DISKUS DPI
Treatment: Devices - METERED-DOSE INHALER (MDI)

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.

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.

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.

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.

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.

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.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

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

Treatment: Devices: 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.

Treatment: Devices: 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.

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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (pre-dose at Day 1) and 3 hours post dose at Week 24
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline (14 days prior to randomization) and Weeks 21 to 24
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Up to Week 52
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Up to Week 52
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Up to Week 52

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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Trowbridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02924688
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications