A Phase 3 interventional study of FF/UMEC/VI and FP/SAL in Asthma, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-25.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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Among 40 studies testing fluticasone furoate in Asthma — none open to participants now, 3 under way, 2 of them phase 3. fluticasone furoate · Asthma.
Among the 40 studies testing fluticasone furoate in Asthma, this one is the 39th largest by enrollment, is the only one that started in 2019, is one of 14 in phase 3, and was the 34th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →None of the 40 studies testing fluticasone furoate in Asthma is open now. The open studies under Asthma, anywhere →
fluticasone furoate: first FDA approval 2007 (FLONASE SENSIMIST ALLERGY RELIEF), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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40 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2019.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 102 across the 40 interventional studies. Of the 35 that completed or were terminated, 22 (63%) have results posted.
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36 of 40 have an industry lead sponsor. The 4 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
261 studies in Asthma by GlaxoSmithKline: 7 open now, 12 under way, 7 of them phase 3. Of 239 finished, 131 (55%) have results posted.
Among the 261 studies in Asthma by GlaxoSmithKline, this one is the 228th largest by enrollment of the 237 interventional ones that give a count, is one of 2 that started in 2019, is one of 61 in phase 3, and was the 227th registered.
GlaxoSmithKline’s Asthma studies by the year they started, since 1999.
1 of the studies testing fluticasone furoate in Asthma that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757102Phase 3GlaxoSmithKlineA Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma | 2027-01-26 |
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Among the 40 studies testing fluticasone furoate in Asthma, from their registry updates:
Among GlaxoSmithKline’s 261 in Asthma:
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Asthma is a common, chronic respiratory disease affecting 1-18 percent of the population. It is accepted that much of the uncontrolled asthma is due to poor adherence and asthma outcomes in such cases may improve simply by increasing adherence to available treatments. GlaxoSmithKline (GSK) has developed a sensor, which clips on to the ELLIPTA® dry powder inhaler (DPI). This will inform subjects if/when they have taken their medication that is in the ELLIPTA inhaler, as well as other information, including: asthma management strategies, tracking of symptoms, asthma triggers, medication reminders and daily asthma forecasts. The sensors, application (app), and provider portal that provide data are subsequently described as the CIS. The combination of once-daily FF/UMEC/VI with the CIS will improve the disease management and adherence. Thus, this study is designed to study the effectiveness and adherence of single inhaler triple therapy (SITT) of FF/UMEC/VI with the CIS as compared to multiple inhaler triple therapy (MITT) of the combination of FP/SAL plus TIO without CIS in subjects with inadequately controlled asthma. The study randomization will be stratified by pre-study inhaled corticosteroids (ICS) dosage strength (mid- or high-dose). Subjects will be randomized in a 1:1 ratio to receive either FF/UMEC/VI delivered via the ELLIPTA DPI with the CIS or FP/SAL delivered via the DISKUS® DPI (with sensor only) plus TIO delivered via the RESPIMAT inhaler (without sensor). The maximum study duration will be approximately 29 weeks, which comprised of prescreen/ screening/ randomization period of up to 4 weeks, 24-week treatment period and a 1-week follow-up period. Approximately 1006 subjects will be randomized in the study. ELLIPTA and DISKUS are registered trademarks of GlaxoSmithKline (GSK) group of companies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will receive SITT of FF/UMEC/VI based on their pre-study ICS dosage strength (mid- or high-dose). Subjects receiving mid-dose of ICS during pre-study will be administered with FF/UMEC/VI (100/62.5/25) mcg inhalation powder via ELLIPTA DPI, once daily in the morning or evening with the CIS. Subjects will also receive albuterol/salbutamol metered dose inhalers (MDIs) as a rescue medication throughout the study.
Drug: FF/UMEC/VI · Drug: Albuterol/salbutamol · Device: ELLIPTA DPI · Device: Metered Dose Inhaler · Device: Connected Inhaler System
Eligible subjects will receive SITT of FF/UMEC/VI based on their pre-study ICS dosage strength (mid- or high-dose). Subjects receiving high-dose of ICS during pre-study will be administered with FF/UMEC/VI (200/62.5/25) mcg inhalation powder via ELLIPTA DPI, once daily in the morning or evening with the CIS. Subjects will also receive albuterol/salbutamol MDI as a rescue medication throughout the study.
Drug: FF/UMEC/VI · Drug: Albuterol/salbutamol · Device: ELLIPTA DPI · Device: Metered Dose Inhaler · Device: Connected Inhaler System
Eligible subjects will receive MITT of FP/SAL+ TIO based on their pre-study ICS dosage strength (mid- or high-dose). Subjects receiving mid-dose of ICS during pre-study will be administered with FP/SAL (250/50) mcg inhalation powder via DISKUS DPI with sensor, twice daily in the morning or evening plus TIO 5 mcg via RESPIMAT inhaler without sensor, once daily in the morning or evening. Subjects will also receive albuterol/salbutamol MDI as a rescue medication throughout the study.
Drug: FP/SAL · Drug: Tiotropium · Drug: Albuterol/salbutamol · Device: DISKUS DPI · Device: RESPIMAT inhaler · Device: Metered Dose Inhaler
Eligible subjects will receive MITT of FP/SAL+ TIO based on their pre-study ICS dosage strength (mid- or high-dose). Subjects receiving high-dose of ICS during pre-study will be administered with FP/SAL (500/50) mcg inhalation powder via DISKUS DPI with sensor, twice daily given in the morning or evening plus TIO 5 mcg via RESPIMAT inhaler without sensor, once daily in the morning or evening. Subjects will also receive albuterol/salbutamol MDI as a rescue medication throughout the study.
Drug: FP/SAL · Drug: Tiotropium · Drug: Albuterol/salbutamol · Device: DISKUS DPI · Device: RESPIMAT inhaler · Device: Metered Dose Inhaler
Drug pages: Fluticasone furoate · GSK573719 · Vilanterol
FF/UMEC/VI will be given as dry white powder delivered via the ELLIPTA DPI once daily in the morning or evening. The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg or 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
FP/SAL will be given as dry white powder delivered via the DISKUS DPI twice daily in the morning or evening. The DISKUS DPI holds a single blister strip with 60 blisters, which contains FP 250 mcg or 500 mcg and SAL 50 mcg per blister.
TIO will be given as clear, colorless, inhalation solution delivered via RESPIMAT inhaler once daily in the morning or evening. The RESPIMAT inhaler will contain 60 puffs with 2.5 mcg TIO per puff.
Drug page: Albuterol
Albuterol/salbutamol will be delivered as a rescue medication via MDI.
The ELLIPTA device will be used to administer FF/UMEC/VI once daily. The ELLIPTA DPI is a molded plastic two-sided inhaler that can hold two individual blister strips, which contain powder formulation for oral inhalation.
The DISKUS device will be used to administer FP/SAL twice daily. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FP/SAL for oral inhalation.
The RESPIMAT inhaler will be used to administer TIO once daily. The RESPIMAT inhaler has a solution filled into a polyethylene/polypropylene cartridge with a polypropylene cap with integrated silicone sealing ring. The cartridge is enclosed within an aluminum cylinder.
Albuterol/salbutamol will be delivered as a rescue medication via MDI.
The CIS will consist of a sensor, which clips on to the ELLIPTA DPI. This will inform subject's if/when they have taken their medication that is in the ELLIPTA inhaler. The sensor will measure when the ELLIPTA inhaler mouth piece cover is fully opened and closed and this data can be fed back, via the app on a mobile device to the subject. The sensors, app, and provider portal that provide data are subsequently described as the CIS.
Percentage of subjects who have an asthma control test (ACT) total score of >=20
The ACT is a self-administered tool to identify subjects with poorly controlled asthma. It is a 5-item questionnaire measuring the frequency of shortness of breath, general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall assessment of asthma control. The response options for all these questions consist of a 5-point scale, ranging from 1 (all the time or not controlled at all for symptoms/activities) to 5 (not at all or completely controlled).
Time frame: Up to 24 weeks
Percentage of subjects with an increase from Baseline of >=3 in ACT total score
The ACT is a self-administered tool to identify subjects with poorly controlled asthma. It is a 5-item questionnaire measuring the frequency of shortness of breath, general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall assessment of asthma control. The response options for all these questions consist of a 5-point scale, ranging from 1 (all the time or not controlled at all for symptoms/activities) to 5 (not at all or completely controlled).
Time frame: Baseline and up to 24 weeks
Annualized rate of moderate and/or severe asthma exacerbations
Annualized rate of moderate/severe asthma exacerbations will be compared to evaluate the effectiveness of FF/UMEC/VI with CIS on improving asthma control compared with FP/SAL+TIO after 24 weeks of treatment. Moderate asthma 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. Severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids, or an increase from a stable maintenance dose, for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Time frame: Up to 24 weeks
Percentage of subjects who have a decrease from Baseline of >=4 in St George's Respiratory Questionnaire (SGRQ) total score
The SGRQ is designed to measure quality of life in subjects with diseases of airway obstruction, measuring symptoms, impact, and activity. It is a well-established instrument, comprising 50 questions to be self-completed by the subject. Higher scores indicate worse health status, and a change of 4 points is considered a clinically relevant change.
Time frame: Baseline and up to 24 weeks
Percentage of ELLIPTA versus DISKUS doses taken as prescribed over the 24-week treatment period
The number of ELLIPTA and DISKUS doses taken will be collected using clip on sensors attached to the inhalers. The sensors will record the precise time and date when the mouthpiece cover of the inhalers has been opened and closed. Adherence is defined as the percentage of ELLIPTA and DISKUS doses taken as prescribed over the study treatment period as determined by the maintenance sensor records of date and time (within a 24-hour time period/window).
Time frame: Up to 24 weeks
Change from Baseline in trough forced expiratory volume in 1 second (FEV1)
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 mean FEV1 value obtained prior to the last dose of investigational product.
Time frame: Baseline and up to 24 weeks
Number of subjects with serious adverse events (SAEs) including hospitalizations for asthma
Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as an SAE. Number of subjects with incidences and type of SAEs including hospitalizations for asthma will be evaluated.
Time frame: Up to 29 weeks from screening
Number of subjects with AEs leading to withdrawal or discontinuation of treatment
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of subjects with AEs leading to withdrawal or discontinuation of treatment will be evaluated.
Time frame: Up to 25 weeks
Number of subjects with AEs leading to dose modification
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of subjects with AEs leading to dose modification will be evaluated.
Time frame: Up to 25 weeks
No study locations are listed for this record.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
Data sharing details ↗ · clinicalstudydatarequest.com
No publications or documents are linked to this record.
Start is estimated for Jan 2019; primary completion for Feb 2021, 24 months later.
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This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluticasone furoate · GSK573719 · Vilanterol