Fluticasone Furoate + Vilanterol for Asthma

Not yet recruiting at 5 trial locations

Overseen By Clinical Disclosure Representative

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sandoz

Must not be taking: Corticosteroids, Antidepressants, Monoclonal antibodies, others

Disqualifiers: Life-threatening asthma, COPD, Heart failure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of combining two medications, Fluticasone Furoate (a corticosteroid) and Vilanterol (a long-acting beta agonist), for people with asthma. Researchers will compare these medications against a placebo to better understand their effectiveness. Individuals who have had asthma for at least 12 weeks and have maintained stability on their current treatment for at least four weeks may be suitable for this trial. Participants must discontinue their regular asthma medications during the study but will have access to a rescue inhaler if needed. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in asthma treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current inhaled asthma medications from the start of the Run-in period until the end of the treatment visit. You will be provided with a rescue inhaler to use as needed during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of Fluticasone Furoate and Vilanterol, known as Breo Ellipta, is generally safe for adults with asthma. Studies support its safety, noting common side effects such as headache, throat irritation, and cough, which are usually mild. Serious side effects are rare.

The FDA has approved this treatment for asthma, confirming its safety. Research has shown it helps control asthma symptoms and improves lung function, which is reassuring. However, discussing any potential risks with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Researchers are excited about the combination of Fluticasone Furoate and Vilanterol for asthma treatment because it offers a unique blend of a corticosteroid and a long-acting beta-agonist in one inhaler. Unlike some standard treatments that might require separate medications, this combined inhalation powder simplifies the regimen, potentially improving patient adherence. Additionally, Fluticasone Furoate is known for its strong anti-inflammatory properties, while Vilanterol provides long-lasting bronchodilation, which together could enhance asthma control more effectively than current options. This dual-action approach has the potential to offer more consistent symptom relief for asthma patients.

What evidence suggests that Fluticasone Furoate and Vilanterol might be an effective treatment for asthma?

Research shows that the combination of fluticasone furoate and vilanterol effectively manages asthma. In this trial, participants will receive either the active treatment of fluticasone furoate and vilanterol inhalation powder or a placebo. Studies have found that this inhaled treatment can reduce severe asthma attacks by reducing inflammation and helping to open airways. Research indicates it significantly lowers the chance of moderate to severe asthma flare-ups. Patients using this treatment have experienced better lung function. This combination is already used for asthma and chronic obstructive pulmonary disease (COPD), yielding good results in both. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with asthma. Participants will stop their current inhaled medications and use a provided rescue inhaler as needed. They must be able to attend multiple study visits, including screening, run-in, treatment periods, and follow-up calls.

Inclusion Criteria

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol

Pre-bronchodilator FEV1 of >40% and <85% of predicted value at Screening

Participants who can demonstrate the correct use of inhaler device during the Run-in period and at Randomization visit

Exclusion Criteria

Participants with uncontrolled allergic rhinitis within 15 days prior to Screening

Participants with clinically significant screening laboratory and electrocardiogram parameters

Participants with hypersensitivity to specific drugs or substances

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 2 weeks

1 visit (in-person)

Run-in

Participants undergo a 2-week Run-in period with training on inhaler use and participant diary

2 weeks

1 visit (in-person)

Treatment

Participants are randomized to receive one inhalation of the study medication or placebo daily for 4 weeks

4 weeks

2 visits (in-person)

Follow-up

Participants are contacted for a safety follow-up call one week after the last site visit

1 week

1 call (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Fluticasone Furoate
• Vilanterol

Trial Overview The study tests if Fluticasone Furoate/Vilanterol powder is equivalent to BREO ELLIPTA for asthma. It's randomized and double-blind, meaning participants are assigned by chance to get the test drug, placebo or BREO ELLIPTA without knowing which one they receive.

How Is the Trial Designed?

Group I: Fluticasone furoate and vilanterol inhalation powder Experimental Treatment 1 Intervention

Fluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg QD for 4 weeks

Group II: Breo Ellipta Active Control 1 Intervention

Fluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg QD for 4 weeks

Group III: Placebo Placebo Group 1 Intervention

Placebo QD for 4 weeks

Who Is Running the Clinical Trial?

Sandoz

Lead Sponsor

Trials

145

Recruited

26,800+

Dr. David Chang

Sandoz

Chief Medical Officer

MD from Albert Einstein College of Medicine

Richard Saynor

Sandoz

Chief Executive Officer since 2019

Bachelor of Pharmacy from the University of Bradford

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK409763/

RESULTS - Fluticasone Furoate/Vilanterol (Breo Ellipta) - NCBI A study with 390 evaluable participants per group had 90% power to detect a 25% reduction in the annual rate of moderate and severe ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1608033

Effectiveness of Fluticasone Furoate–Vilanterol for COPD ... Results. The rate of moderate or severe exacerbations was significantly lower, by 8.4% (95% confidence interval, 1.1 to 15.2), with fluticasone ...

3. fda.gov fda.gov/media/164263/download

Breo Ellipta (Fluticasone Furoate/Vilanterol Inhalation ... Inhaled corticosteroids (ICS) are considered the most effective anti-inflammatory treatments for all severities of persistent asthma. ... To achieve long term ...

4. trelegyhcp.com trelegyhcp.com/asthma/efficacy/

Efficacy vs BREO | TRELEGY ELLIPTA (fluticasone furoate ... TRELEGY 100 demonstrated a significant 110 mL lung function improvement vs BREO 100 (P<0.001). 1 TRELEGY 200 demonstrated 2X greater lung function improvement ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02770903.2021.1963767

Full article: Symptom control in patients with asthma using ... Treatment with fluticasone furoate/vilanterol (FF/VI), an inhaled corticosteroid/long-acting β2-agonist therapy, reduces the risk of severe asthma exacerbations ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK409776/

Fluticasone Furoate/Vilanterol (Breo Ellipta) - NCBI - NIH Fluticasone furoate plus vilanterol reduced exacerbations over one year versus vilanterol alone, although there were inconsistent results for improvements in ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/204275s022lbl.pdf

Breo Ellipta (fluticasone furoate - accessdata.fda.gov The safety of BREO ELLIPTA for the maintenance treatment of asthma in adult patients was based on the data from Trials 8, 9, 10, 11 and 12 [see Clinical ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03248128

NCT03248128 | Safety and Efficacy Study of Fluticasone ... Thus, this study is designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component) compared to FF alone for the treatment of asthma, in ...

9. mybreo.com mybreo.com/

BREO homepage | BREO ELLIPTA (fluticasone furoate and ... Vilanterol opens lung airways by helping the muscles around them stay relaxed, preventing asthma symptoms such as wheezing, coughing, chest tightness, and ...

10. mayoclinic.org mayoclinic.org/drugs-supplements/fluticasone-and-vilanterol-inhalation-route/description/drg-20061007

Fluticasone and vilanterol (inhalation route) - Side effects & ... Fluticasone and vilanterol combination is used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been ...