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AsthmaPhase 3NCT02446418

A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma

A Phase 3 study testing Fluticasone Furoate, Vilanterol and Fluticasone propionate in people with Asthma, run by GlaxoSmithKline at 93 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and efficacy of FF/VI in asthma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
Fluticasone Furoate, Vilanterol and Fluticasone propionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
423 participants
Where
93 sitesin 2 countries
Study dates
9 Jul 2015to 20 Jul 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
  • Gender and Age: Male or female subjects aged >=18 and <=75years of age at Screening visit.
  • Female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies:
  • Non-reproductive potential defined as: Pre-menopausal females with one of the following - Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause [refer to laboratory reference ranges for confirmatory levels]); Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods 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.
  • Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until Week 24.
  • GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP:
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  • This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis: Contraceptive subdermal implant that meets the Standard Operating Procedure (SOP) effectiveness criteria including a <1percent rate of failure per year, as stated in the product label; Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1 percent rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject; Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
  • Type of subject: Subjects with documented physician's diagnosis of asthma >=1 year, unsatisfactorily controlled asthma (ACT <20 at Screening and Randomisation visit) treated by ICS alone and intended to be treated by ICS/LABA maintenance therapy; France Only: A subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a Social Security category.
  • Current Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS alone without LABA for at least 4 weeks prior to Randomisation visit; Other background asthma medication such as anti-leukotrienes or theophylline is permitted as an alternative to ICS alone, if initiated at least 4 weeks prior to screening visit.
  • Subject questionnaires Subjects must be able to complete the questionnaires themselves.

Who cannot join

  • History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months before Screening and Randomisation visit.
  • Subjects having a severe and unstable asthma, with ACT score < 15 at Visit 1 and at Visit 2, and/or a history of repeated severe exacerbations (3/year) and/or a severe exacerbation in the previous 6 weeks before Visit 1 and Visit 2.
  • Chronic obstructive pulmonary disease (COPD) Respiratory Disease: A subject must not have current evidence or diagnosis of chronic obstructive pulmonary disease at Screening visit.
  • Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)].
  • Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease at Screening and Randomisation visit. 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.
  • Subjects with a history of adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid and LABA therapy and to components of the inhalation powder (e.g., lactose, magnesium stearate) at Screening and Randomisation visit. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded.
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  • Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Randomisation visit or within five half-lives (t½) of the prior investigational study (whichever is longer of the two), (if unsure discuss with the medical monitor prior to screening).
  • Chronic user of systemic corticosteroids: A subject who, in the opinion of the Investigator, is considered to be a chronic user of systemic corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening) at Screening visit.
  • Subjects treated by the monoclonal antibody omalizumab or mepolizumab at Visit 1. Treatment with omalizumab or mepolizumab is not allowed during the study.
  • Subjects involved in other clinical trials at Screening visit.
  • Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
  • Subjects who plan to move away from the geographical area where the study is being conducted during the study.

Trial locations and contacts

93 sites in 2 countries.

93 sites in 2 countries

France72 sites

  • GSK Investigational Site

    Amiens, 80090

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Avelin, 59710

  • GSK Investigational Site

    Bassussarry, 64200

  • GSK Investigational Site

    Beauzelle, 31700

  • GSK Investigational Site

    Bécon-les-Granits, 49370

  • GSK Investigational Site

    Bersée, 59235

  • GSK Investigational Site

    Béziers, 34500

  • GSK Investigational Site

    Biarritz, 64200

  • GSK Investigational Site

    Bourg-des-Comptes, 35890

  • GSK Investigational Site

    Broglie, 27270

  • GSK Investigational Site

    Bruay-la-Buissière, 62700

  • GSK Investigational Site

    Caen, 14000

  • GSK Investigational Site

    Cannes, 06614

  • GSK Investigational Site

    Carbon-Blanc, 33560

  • GSK Investigational Site

    Châtellerault, 86100

  • GSK Investigational Site

    Colombey-les-Belles, 54170

  • GSK Investigational Site

    Coulounieix-Chamiers, 24660

  • GSK Investigational Site

    Cournonterral, 34660

  • GSK Investigational Site

    Dessenheim, 68600

  • GSK Investigational Site

    Dijon, 21000

  • GSK Investigational Site

    Dinard, 35800

  • GSK Investigational Site

    Donges, 44480

  • GSK Investigational Site

    Ermont, 95124

  • GSK Investigational Site

    Fléville-devant-Nancy, 54710

  • GSK Investigational Site

    Gémenos, 13420

  • GSK Investigational Site

    Gondreville, 54840

  • GSK Investigational Site

    Grenay, 62160

  • GSK Investigational Site

    Guesnain, 59287

  • GSK Investigational Site

    Hatten, 67690

  • GSK Investigational Site

    Hinx, 40180

  • GSK Investigational Site

    La Bouëxière, 35340

  • GSK Investigational Site

    La Fôret Sur Sèvres, 79380

  • GSK Investigational Site

    La Riche, 37520

  • GSK Investigational Site

    Lambersart, 59130

  • GSK Investigational Site

    Laval, 53000

  • GSK Investigational Site

    Le Blanc-Mesnil, 93150

  • GSK Investigational Site

    Limoges, 87000

  • GSK Investigational Site

    Marseille, 13331

  • GSK Investigational Site

    Metz-Tessy, 74370

  • GSK Investigational Site

    Montauban, 82017

  • GSK Investigational Site

    Montpellier, 34070

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Mûrs-Erigné, 49610

  • GSK Investigational Site

    Nancy, 54000

  • GSK Investigational Site

    Nantes, 44200

  • GSK Investigational Site

    Nantes, 44300

  • GSK Investigational Site

    Narbonne, 11100

  • GSK Investigational Site

    Nice, 06000

  • GSK Investigational Site

    Obernai, 67210

  • GSK Investigational Site

    Paris, 75020

  • GSK Investigational Site

    Perpignan, 66000

  • GSK Investigational Site

    Rosiers-d'Égletons, 19300

  • GSK Investigational Site

    Rouen, 76000

  • GSK Investigational Site

    Royaumeix, 54200

  • GSK Investigational Site

    Saint-Etienne, 42000

  • GSK Investigational Site

    Saint-Etienne, 42100

  • GSK Investigational Site

    Saint-Ouen-la-Rouërie, 35460

  • GSK Investigational Site

    Scorbé-Clairvaux, 86140

  • GSK Investigational Site

    Segré, 49500

  • GSK Investigational Site

    Soulac-sur-Mer, 33780

  • GSK Investigational Site

    Strasbourg, 67000

  • GSK Investigational Site

    Thouars, 79100

  • GSK Investigational Site

    Toul, 54200

  • GSK Investigational Site

    Toulon, 83000

  • GSK Investigational Site

    Toulouse, 31077

  • GSK Investigational Site

    Toulouse, 31300

  • GSK Investigational Site

    Verzy, 51380

  • GSK Investigational Site

    Vieux-Condé, 59690

  • GSK Investigational Site

    Villejuif, 94800

  • GSK Investigational Site

    Wattrelos, 59150

  • GSK Investigational Site

    Witry-lès-Reims, 51420

Other trials in France

Germany21 sites

  • GSK Investigational Site

    Berlin, 10119

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 13156

  • GSK Investigational Site

    Berlin, 14059

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44263

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04207

  • GSK Investigational Site

    Leipzig, Saxony, 04275

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Magdeburg, 39120

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Munich, Bavaria, 81241

  • GSK Investigational Site

    Potsdam, Brandenburg, 14469

  • GSK Investigational Site

    Rheine, North Rhine-Westphalia, 48431

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Teuchern, Saxony-Anhalt, 6682

  • GSK Investigational Site

    Wallerfing, Bavaria, 94574

Other trials in Germany

About this study

Official title: A 6-month, Open Label, Randomised, Efficacy Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via the Dry Powder Inhaler ELLIPTA™ Compared With Usual ICS/LABA Maintenance Therapy Delivered by Dry Powder Inhaler in Subjects With Persistent Asthma

The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised clinical trials tend to be highly controlled and enrol a more highly selected subject population than is expected to be prescribed the medication post-approval. There is a need for data in a more representative population in close to a 'real life' conditions, where physicians have the ability to choose the best treatment in their view for any individual subject and adapt treatments to subjects' characteristics and response. This multi-center, open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol [FP/S] or budesonide/formoterol [BUD/F]) in subjects with persistent asthma, in a "close to real life" settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™ DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.

Conditions
Asthma
Being tested
Fluticasone Furoate, Vilanterol, Fluticasone propionate, Salmeterol, Budesonide
Keywords
dry powder inahler, vilanerol, efficacy, safety, fluticasone furoate, quality of life
Medical subject headings
Asthma

What participants receive

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

  • Fluticasone FuroateDrug

    FF 92 mcg or 184 mcg blended with lactose administered once daily via ELLIPTA DPI

  • VilanterolDrug

    Vilanterol 22 mcg blended with lactose and magnesium stearate administered once daily via ELLIPTA DPI

  • Fluticasone propionateDrug

    FP 250 mcg or 500 mcg blended with lactose administered twice daily via DISKUS DPI

  • SalmeterolDrug

    Salmeterol 50 mcg blended with lactose administered twice daily via DISKUS DPI

  • BudesonideDrug

    Budesonide 200 mcg or 400 mcg blended with lactose administered twice daily via TURBUHALER DPI

  • Formoterol FumarateDrug

    Formoterol Furoate 6 mcg or 12 mcg blended with lactose administered twice daily via TURBUHALER DPI

Study groups in NCT02446418
Study groupRoleWhat they receive
Fluticasone Furoate/VilanterolExperimentalSubjects will receive FF/VI 92 micrograms (mcg)/22 mcg or FF/VI 184 mcg/22 mcg as decided by the investigator QD via ELLIPTA DPI for 24 weeks.
Receives: Drug: Fluticasone Furoate; Drug: Vilanterol
FP/S OR BUD/FActive comparatorSubjects will receive FP/S (250 mcg/50 mcg or 500 mcg/50mcg) twice daily via DISKUS or BUD /F (200 mcg/6mcg or 400 mcg/12mcg one or two inhalations) twice daily via TURBUHALER DPI as decided by the investigator for 24 weeks.
Receives: Drug: Fluticasone propionate; Drug: Salmeterol; Drug: Budesonide; Drug: Formoterol Fumarate

What is being measured

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

  1. Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12

    The ACT is a validated self-completed questionnaire consisting of 5 questions that evaluate asthma control during the past 4 weeks on a 5-point categorical scale. Total scores are calculated from the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the last assessment prior to randomization (Day 0). Change from Baseline was post-dose visit value minus the Baseline value. Least square mean change is presented.

    Measured: Baseline and Week 12

Secondary outcomes (2)

  1. Change From Baseline in ACT Total Score at Week 24

    The ACT is a validated self-completed questionnaire consisting of 5 questions that evaluate asthma control on a 5-point categorical scale. Total scores are calculated from the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the last assessment prior to randomization (Day 0). Change from Baseline was post-dose visit value minus the Baseline value. Least square mean change is presented.

    Measured: Baseline and Week 24

  2. Percentage of Participants With Correct Use of Device, Defined as Not Making Any Critical or Non-critical Errors, at Week 12, and at Week 24 Independently of the Use at Week 12

    Participants were asked to read the appropriate package insert for their prescribed inhaler and then the investigator (or suitably qualified designee) demonstrated the proper use of the inhaler. The participant was then asked to self-administer their first dose of study treatment under the supervision of the investigator and any critical and non-critical errors were recorded. Individual instruments for assessing correct inhaler use were provided for each of the three devices used in this study.

    Measured: Week 12 and Week 24

Timeline

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

  1. First posted18 May 2015 (estimated)
  2. Study start9 Jul 2015
  3. Primary completion20 Jul 2017
  4. Study completion20 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
423 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446418
Sponsor's protocol ID
116492
Status last verified
Jun 2018
First submitted
14 May 2015
Last updated
14 Jan 2019
Data monitoring committee
No

Publications

  • Devillier P, Humbert M, Boye A, Zachgo W, Jacques L, Nunn C, West S, Nicholls A, Antoun Z, Spinu L, Grouin JM. Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting beta2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial. Respir Med. 2018 Aug;141:111-120. doi: 10.1016/j.rmed.2018.06.009. Epub 2018 Jun 9.

    PubMed 30053956

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Furoate, Vilanterol and Fluticasone propionate in people with Asthma, run by GlaxoSmithKline at 93 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446418, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.

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