A Phase 4 interventional study of Fluticasone Furoate/Vilanterol and Fluticasone Furoate in Asthma, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 one of 3 that started in 2018, is one of 6 in phase 4, and was the 33rd 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.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2018.
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.
This tab as a report to print or save as PDF → With an account.
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 9 that started in 2018, is one of 53 in phase 4, and was the 226th 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 |
Add it to your calendar (.ics) → With an account.
Among the 40 studies testing fluticasone furoate in Asthma, from their registry updates:
Among GlaxoSmithKline’s 261 in Asthma:
This tab as a report to print or save as PDF → With an account.
The objective of this study is to evaluate fluticasone furoate/vilanterol compared with fluticasone furoate alone in subjects with asthma that is uncontrolled on low to mid dose inhaled corticosteroid (ICS) or low dose ICS/ long acting beta agonist (LABA) combination. This is a phase IV, randomized, double-blind, parallel group, multicenter study evaluating fluticasone furoate/vilanterol 100/25 micrograms (mcg) and fluticasone furoate 100 mcg once daily, delivered as an inhalation powder using the ELLIPTA® device in subjects with uncontrolled asthma despite daily ICS or ICS/LABA therapy. The study will measure treatment response and asthma control using the Asthma Control Questionnaire-7 (ACQ-7) focusing on symptomatic control. In this study, proportion of subjects with an improvement in ACQ-7 score of >=0.5 at Week 12 compared to Baseline for the fluticasone furoate/vilanterol 100 mcg/25 mcg and fluticasone furoate100 mcg groups will be assessed. The total study duration for each subject will be 17 weeks including 4-week run in period, 12-week treatment period and 1-week follow up period. Approximately 1012 subjects will be randomized into the study. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
Screening Inclusion Criteria
Screening Exclusion Criteria
Randomisation Inclusion Criteria
Randomisation 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.
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.
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.
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.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
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.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive fluticasone furoate/vilanterol 100/25 mcg inhalation powder via ELLIPTA dry powder inhaler (DPI) once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis.
Drug: Fluticasone Furoate/Vilanterol · Drug: Salbutamol/Albuterol
Subjects will receive fluticasone furoate 100 mcg inhalation powder via ELLIPTA DPI once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis.
Drug: Fluticasone Furoate · Drug: Salbutamol/Albuterol
Drug pages: Fluticasone furoate · Vilanterol
Fluticasone furoate/vilanterol will be supplied as inhalation powder in ELLIPTA DPI. It will contain 2 strips with 30 blisters per strip. First strip will contain fluticasone furoate 100 mcg dry white powder blended with lactose. Second strip will contain vilanterol 25 mcg dry white powder blended with lactose and magnesium stearate.
Fluticasone furoate will be supplied as inhalation powder in ELLIPTA DPI. It will contain a single strip with 30 blisters, containing fluticasone furoate 100 mcg dry white powder blended with lactose.
Drug page: Albuterol
Salbutamol/albuterol will be provided to subjects to use as rescue medication on an as-needed basis.
Number of subjects with an improvement in ACQ-7 score of >= 0.5 at Week 12 compared to Baseline
The ACQ-7 consists of five questions about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) in the previous week, along with one question on daily bronchodilator use in the previous week, and a measure of lung function (forced expiratory volume in 1 second \[FEV1\] % predicted). The response options for all these questions consist of a zero (no impairment) to six (total impairment) scale. The questions are equally weighted, and the ACQ-7 score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A score \>= 1.5 indicates asthma that is not well controlled, while a mean score of \<= 0.75 indicates asthma that is well controlled, with a change of 0.5 defined as the minimal clinically important difference.
Time frame: Baseline and at Week 12
Change from Baseline in the percentage of rescue-free daytime periods during the 12-week treatment period
Subjects will be issued an electronic diary for use during the study. Subjects will record daytime asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the daytime period. Symptoms and rescue use will be recorded between Visits 1 (Week-4) and 4 (Week 12), once in the evening (reporting daytime symptoms) before taking any rescue medication or ICS. Each evening, participants will record an asthma symptom score using the following scale: 1 = no symptoms during the day 2 = symptoms for one short period during the day 3 = symptoms for two or more short periods during the day 4 = symptoms for most of the day which did not affect my normal daily activities 5 = symptoms for most of the day which did affect my normal daily activities, 6 = symptoms so severe that I could not go to work or perform normal daily activities.
Time frame: Baseline and up to Week 12
Change from Baseline in the percentage of rescue-free night time periods during the 12-week treatment period
Subjects will be issued an electronic diary for use during the study. Subjects will record night time asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the night time period. Symptoms and rescue use will be recorded twice a day between Visits 1 (Week-4) and 4 (Week 12), once in the morning (reporting night time symptoms) before taking any rescue medication or ICS. Each morning, subjects will record an asthma symptom score using the following scale: 1 = no symptoms during the night, 2 = symptoms causing me to wake once (or wake early), 3 = symptoms causing me to wake twice or more (including waking early), 4 = symptoms causing me to be awake for most of the night, and 5 = symptoms so severe that I did not sleep at all.
Time frame: Baseline and up to Week 12
Change from Baseline in the percentage of symptom-free daytime periods during the 12-week treatment period
Subjects will be issued an electronic diary for use during the study. Subjects will record daytime asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the daytime period. Symptoms and rescue use will be recorded between Visits 1 (Week-4) and 4 (Week 12), once in the evening (reporting daytime symptoms) before taking any rescue medication or ICS.
Time frame: Baseline and up to Week 12
Number of subjects with an ACQ-7 score <= 0.75 at Week 12
The ACQ-7 consists of five questions about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) in the previous week, along with one question on daily bronchodilator use in the previous week, and a measure of lung function (FEV1 % predicted). The response options for all these questions consist of a zero (no impairment) to six (total impairment) scale. The questions are equally weighted, and the ACQ-7 score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A score \>=1.5 indicates asthma that is not well-controlled, while a mean score of \<= 0.75 indicates asthma that is well-controlled, with a change of 0.5 defined as the minimal clinically important difference.
Time frame: Baseline and at Week 12
Change from Baseline in the percentage of symptom-free night time periods during the 12-week treatment period
Subjects will be issued an electronic diary for use during the study. Subjects will record night time asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the night time periods. Symptoms and rescue use will be recorded between Visits 1 (Week-4) and 4 (Week 12), once in the morning (reporting night time symptoms) before taking any rescue medication or ICS.
Time frame: Baseline and up to Week 12
No study locations are listed for this record.
Start is estimated for Mar 2018; primary completion for May 2019, 14 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Fluticasone furoate · Vilanterol