CLINICAL TRIALS PROFILE FOR FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

All Clinical Trials for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03184987 ↗	A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma	Completed	BI Medical.Inc	Phase 3	2017-06-22	Despite availability of treatments and published guidelines, subjects may have asthma that is inadequately controlled. GlaxoSmithKline is currently developing a once-daily 'closed' triple therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic Antagonist (ICS/LAMA/LABA) combination (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate [FF/UMEC/VI]) in a single device, 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 study has 3 study periods: Run-in, Treatment period and a Follow-up period. Eligible subjects who meet the pre-defined criteria at screening (Visit 1) will enter into a 2-week run-in period. Subjects will continue their pre-screening inhaled medications for asthma (ICS+LABA or ICS+LABA+LAMA) without any change in regimen/dosage until day before Visit 2. At Visit 2 subjects will be allocated to either FF/UMEC/VI 100/62.5/25 or FF/UMEC/VI 200/62.5/25 micrograms (mcg) treatment depending on the asthma control status for 52 weeks. Switching medication from FF/UMEC/VI 100/62.5/25 to FF/UMEC/VI 200/62.5/25 will be permitted in accordance with the control status of the subject assessed by Asthma Control Questionnaire (ACQ)-7 at Week 24 of the treatment period. A follow-up visit will be conducted for approximately 1 week. Subjects will be provided with salbutamol as a rescue medication throughout the study.
NCT03184987 ↗	A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma	Completed	Parexel International Japan	Phase 3	2017-06-22	Despite availability of treatments and published guidelines, subjects may have asthma that is inadequately controlled. GlaxoSmithKline is currently developing a once-daily 'closed' triple therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic Antagonist (ICS/LAMA/LABA) combination (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate [FF/UMEC/VI]) in a single device, 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 study has 3 study periods: Run-in, Treatment period and a Follow-up period. Eligible subjects who meet the pre-defined criteria at screening (Visit 1) will enter into a 2-week run-in period. Subjects will continue their pre-screening inhaled medications for asthma (ICS+LABA or ICS+LABA+LAMA) without any change in regimen/dosage until day before Visit 2. At Visit 2 subjects will be allocated to either FF/UMEC/VI 100/62.5/25 or FF/UMEC/VI 200/62.5/25 micrograms (mcg) treatment depending on the asthma control status for 52 weeks. Switching medication from FF/UMEC/VI 100/62.5/25 to FF/UMEC/VI 200/62.5/25 will be permitted in accordance with the control status of the subject assessed by Asthma Control Questionnaire (ACQ)-7 at Week 24 of the treatment period. A follow-up visit will be conducted for approximately 1 week. Subjects will be provided with salbutamol as a rescue medication throughout the study.
NCT03184987 ↗	A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma	Completed	Q2 Solutions	Phase 3	2017-06-22	Despite availability of treatments and published guidelines, subjects may have asthma that is inadequately controlled. GlaxoSmithKline is currently developing a once-daily 'closed' triple therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic Antagonist (ICS/LAMA/LABA) combination (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate [FF/UMEC/VI]) in a single device, 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 study has 3 study periods: Run-in, Treatment period and a Follow-up period. Eligible subjects who meet the pre-defined criteria at screening (Visit 1) will enter into a 2-week run-in period. Subjects will continue their pre-screening inhaled medications for asthma (ICS+LABA or ICS+LABA+LAMA) without any change in regimen/dosage until day before Visit 2. At Visit 2 subjects will be allocated to either FF/UMEC/VI 100/62.5/25 or FF/UMEC/VI 200/62.5/25 micrograms (mcg) treatment depending on the asthma control status for 52 weeks. Switching medication from FF/UMEC/VI 100/62.5/25 to FF/UMEC/VI 200/62.5/25 will be permitted in accordance with the control status of the subject assessed by Asthma Control Questionnaire (ACQ)-7 at Week 24 of the treatment period. A follow-up visit will be conducted for approximately 1 week. Subjects will be provided with salbutamol as a rescue medication throughout the study.

Clinical Trial Conditions for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Condition Name

Condition Name for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
Intervention	Trials
Asthma	2

Condition MeSH

Condition MeSH for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
Intervention	Trials
Asthma	2

Clinical Trial Locations for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Trials by Country

Trials by Country for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
Location	Trials
United States	16
Australia	4
Japan	2
Canada	2
Argentina	1

Trials by US State

Trials by US State for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
Location	Trials
Texas	1
South Carolina	1
Pennsylvania	1
Ohio	1
North Carolina	1

Clinical Trial Progress for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Clinical Trial Phase

Clinical Trial Phase for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
Clinical Trial Phase	Trials
PHASE4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
Clinical Trial Phase	Trials
ACTIVE_NOT_RECRUITING	1
Completed	1

Clinical Trial Sponsors for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Sponsor Name

Sponsor Name for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
Sponsor	Trials
GlaxoSmithKline	2
York Bioanalytical Solution	1
BI Medical.Inc	1

Sponsor Type

Sponsor Type for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
Sponsor	Trials
Other	4
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate

Last updated: November 1, 2025

Introduction

The combination of fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate represents an innovative therapeutic regimen primarily targeting patients with chronic obstructive pulmonary disease (COPD) and asthma. This triple therapy regimen aims to improve lung function, reduce exacerbations, and enhance quality of life. The drug combination, often marketed under brand names like Trelegy Ellipta, has gained regulatory approval across major markets, notably the US, Europe, and Asia. Its evolving clinical landscape, market penetration, and future growth prospects warrant comprehensive analysis.

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Clinical Trials Landscape and Updates

Historical Context and Regulatory Approvals

The triple combination of fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate received FDA approval in October 2017 primarily for COPD treatment. Subsequent approvals expanded indications to include asthma, highlighting its versatility.

Current and Ongoing Clinical Studies

Recent clinical trials focus on several key areas:

• Efficacy and Safety in Diverse Populations:
  Phase III studies continue to affirm the drug's efficacy in reducing exacerbations and improving lung function. Notably, trials in elderly populations and those with co-morbidities are underway to assess safety profiles across broader demographics [1].

• Long-term Safety Evaluations:
  Extended duration studies are evaluating the risk of pneumonia, cardiovascular events, and systemic corticosteroid effects. These are critical to addressing clinician and patient concerns about inhaled corticosteroids' side effects.

• New Indications and Combination Strategies:
  Trials are exploring adjunctive therapies, such as biologics, in patients with refractory COPD or asthma. Although still early, data suggest potential expansion of the existing drug’s use cases.

Emerging Trends

• Real-world Evidence (RWE):
  Increased collection of RWE indicates real-world adherence and effectiveness, strengthening the regulatory and market cases for continued use [2].

• Pharmacogenomic Studies:
  Novel studies are assessing genetic markers predictive of treatment response, aiming to personalize therapy and improve outcomes.

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Market Analysis

Market Dynamics and Drivers

The COPD and asthma therapeutics market is experiencing significant growth driven by:

• Growing Prevalence:
  COPD affected over 300 million people globally in 2019, with projections indicating a rise to 500 million by 2030 due to aging populations and environmental factors [3].

• Need for Fixed-Dose Combinations (FDCs):
  The convenience of once-daily inhalers like Trelegy Ellipta enhances adherence and reduces pill burden, aligning with patient preferences.

• Regulatory Approvals and Label Expansions:
  Broader indications and ongoing supportive data reinforce ongoing market acceptance.

• Market Penetration and Competitive Landscape:
  Trelegy Ellipta holds a significant position, with competitors including combination therapies with similar components from GSK, AstraZeneca, and Novartis. Its ease of use and validated efficacy have maintained a strong market share.

Market Breakdown

• Region-wise Distribution:

  • North America remains the largest market, accounting for over 40% of sales, driven by high COPD prevalence and strong healthcare infrastructure.
  • Europe follows, with Germany, the UK, and France leading adoption.
  • Asia-Pacific witnesses rapid growth, propelled by rising awareness, improving healthcare access, and expanding reimbursement policies.

• Pricing and Reimbursement:
  High drug costs pose barriers, especially in developing economies. The availability of generic versions could influence future pricing dynamics.

Revenue and Growth Projections

The global market for inhaled triple therapies such as this combo is projected to grow at a CAGR of approximately 8.5% from 2023 to 2030, reaching over $7 billion by 2030 [4]. The growth is propelled by continued adoption in clinical practice, expanded indications, and new formulation innovations.

Challenges and Risks

• Side Effect Profile Concerns:
  Risks of pneumonia from inhaled corticosteroids and cardiovascular events remain key concerns impacting prescribing practices.

• Patent Expirations:
  Intellectual property expirations in the next 5–7 years could lead to generic competition, compressing profit margins.

• Competitive Innovations:
  Development of novel biologics and non-inhaled therapies could alter the market landscape.

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Future Outlook and Market Projections

The outlook for this drug combination remains optimistic, supported by relentless clinical research, expanding indications, and its status as a gold-standard treatment in COPD management. Innovations aimed at improving delivery devices, optimizing dosing, and reducing side effects are likely essential to sustain growth.

Market Opportunities

• Personalized Medicine:
  Integrating pharmacogenomics to target subpopulations with higher response rates can strengthen market position.

• Combination with Ancillary Therapies:
  Synergistic use with biologic agents for severe asthma or COPD offers expansion pathways.

• Emerging Markets:
  Accelerated healthcare infrastructure development in Asia, Africa, and Latin America offers long-term growth potential.

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Key Takeaways

• The combination therapy of fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate is underpinned by a robust clinical trial pipeline, confirming its safety and efficacy profiles across diverse patient groups.

• Market growth is driven by rising COPD and asthma prevalence, preference for fixed-dose inhalers, and expanding regulatory approvals.

• Despite strong sales, challenges such as side effect profiles, patent cliffs, and intense competition necessitate strategic innovation and diversification.

• Future growth depends on personalized approaches, device improvements, and entry into emerging markets, which can underpin sustained revenue streams.

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FAQs

1. What are the main indications for the combination of fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate?
This triple therapy is primarily indicated for the management of COPD and has been approved for asthma in certain regions, especially for patients requiring multiple agents to control symptoms and reduce exacerbations [1].

2. How does this combination compare to other COPD therapies?
It offers the convenience of a once-daily inhaler combining corticosteroid, anticholinergic, and long-acting beta-agonist agents, providing comprehensive symptom control and improved adherence relative to multiple separate inhalers.

3. What are the major side effects associated with this drug?
Key adverse effects include increased risk of pneumonia, systemic steroid effects, and cardiovascular events. The benefit-risk ratio remains favorable with proper patient selection [2].

4. Are there ongoing clinical trials investigating new applications of this combination?
Yes, research continues into new indications, such as refractory asthma, and into improving the safety profile through formulation enhancements [1].

5. What is the projected trajectory for this drug’s market over the next decade?
The market is expected to grow at a CAGR of around 8.5%, reaching over $7 billion globally by 2030, driven by expanding indications and geographic penetration [4].

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References

[1] National Institutes of Health. ClinicalTrials.gov. "Efficacy and Safety of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate in Respiratory Diseases," 2022.

[2] GSK. Trelegy Ellipta Prescribing Information, 2022.

[3] World Health Organization. Global Surveillance, Prevention, and Control of Chronic Respiratory Diseases, 2021.

[4] MarketWatch. Inhaled Triple Therapy Market Analysis and Forecast, 2022-2030.

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This detailed market and clinical update provides healthcare executives, investors, and policymakers with strategic insights into the potential and challenges associated with this triple combination therapy, aiding informed decision-making.