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.
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, LLC	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	SRL Mediserch.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	York Bioanalytical Solution	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
South Korea	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
SRL Mediserch.Inc	1
York Bioanalytical Solution	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; Vilanterol Trifenatate

Last updated: January 31, 2026

Executive Summary

This report provides a comprehensive overview of the clinical development, market dynamics, and future projections for the combination drug comprising Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate. Known commercially as Trelegy Ellipta, this inhalation therapy signifies a significant advancement in the management of chronic obstructive pulmonary disease (COPD) and asthma.

Key developments include ongoing and upcoming clinical trials, regulatory milestones, market penetration strategies, and competitive positioning. While recent clinical data reinforce the drug’s efficacy, particularly in reducing exacerbations and improving lung function, market penetration faces competition from existing therapies. The global COPD treatment market, projected to reach USD 13.4 billion by 2028 at a CAGR of 4.2%, underscores the product's growth potential.

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1. Clinical Trials Update

1.1. Current Clinical Development Status

The drug combination of Fluticasone Furoate (FF), Umeclidinium Bromide (UMEC), and Vilanterol (VI) is primarily marketed as Trelegy Ellipta (GSK). Its approval by major regulatory bodies, including the FDA (2017) and EMA (2018), was based on pivotal clinical trials demonstrating superior efficacy compared to dual therapies.

1.2. Ongoing and Future Clinical Trials

Recent trials focus on expanded indications, long-term safety, and comparative efficacy:

Trial ID	Title	Phase	Focus	Estimated Completion	Status
NCT03572539	GlaxoSmithKline COPD Assessment	Phase 4	Long-term safety	Q4 2023	Ongoing
NCT04588046	COPD Exacerbation Reduction	Phase 4	Exacerbation rates	Q1 2024	Ongoing
NCT03860388	Asthma Management in Elderly	Phase 3	Efficacy in elderly	Q2 2024	Ongoing

Note: NCTs are clinical trial registry IDs.

1.3. Regulatory and Labeling Updates

Recent regulatory updates include EMA’s inclusion of Trelegy Ellipta in the treatment of eosinophilic COPD, expanding its label beyond initial indications. Post-marketing surveillance continues to affirm safety with rare adverse events like oropharyngeal candidiasis and nasopharyngitis.

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2. Market Analysis

2.1. Therapeutic Landscape and Indications

• Primary Indication: COPD, particularly for maintenance therapy in moderate to severe cases.
• Secondary Indication: Asthma, especially in patients requiring triple therapy.
• Key Competitors:
  • Breo Ellipta (Fluticasone Furoate/Vilanterol)
  • Anoro Ellipta (Umeclidinium/Vilanterol)
  • Trimbow (Beclometasone/Formoterol/Glycopyrronium)

2.2. Market Penetration and Share

As of 2022, Trelegy Ellipta maintains a leading position in triple therapy, capturing approximately 25% of the triple-inhaler market segment with annual sales surpassing USD 2.2 billion globally.

2.3. Geographic Breakdown

Region	Market Share	Sales (USD millions)	Growth Rate (2022-2028)	Regulatory Status
North America	45%	990	3.8% CAGR	Approved & Widely Used
Europe	35%	770	4.5% CAGR	Approved & Gaining Traction
Asia-Pacific	12%	264	7.2% CAGR	Pending regulatory approval in China & Japan
Rest of World	8%	176	5.0% CAGR	Limited access

Sources: IQVIA; GSK Reports 2022; GlobalData.

2.4. Pricing and Reimbursement

Average wholesale prices (AWP) for Trelegy Ellipta approximate USD 400/month per inhaler in the US. Reimbursement coverage remains robust under Medicare and private insurers, supporting sustained sales growth.

2.5. Market Drivers & Barriers

Drivers	Barriers
Increasing COPD prevalence (approx. 200 million globally)	High drug cost
Rising adoption of triple inhalers	Competition from lower-cost dual therapies
FDA/EMA expanding label indications	Patient adherence challenges

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3. Market Projection and Future Outlook

3.1. Forecast Overview

By 2028, the global COPD inhalation therapy market is projected to reach USD 13.4 billion, with Trelegy Ellipta forecasted to sustain its market share through continued clinical validation and market expansion.

Year	Projected Sales (USD millions)	CAGR	Dominant Markets
2023	2,500	-	US, Europe, Japan
2024	2,850	13.2%	US, Europe, APAC expansion
2025	3,250	14.0%	Increased adoption in Asia-Pacific
2026	3,675	13.0%	Broader label expansion
2027	4,125	12.4%	Generic competition emergence
2028	4,500	9.3%	Penetration into emerging markets

Sources: MarketWatch; GSK forecasts; industry reports.

3.2. Competitive Dynamics and Market Entry Strategies

GSK’s strategy involves maintaining clinical leadership, expanding label indications, and engaging in partnerships in emerging markets. Competition from new fixed-dose combinations (FDCs) may pressure prices; thus, innovation and differentiation remain critical.

3.3. Impact of Policy & Patent Life

Patent protection extends until 2032 in key markets, providing exclusivity. Biosimilar or generic challenges are unlikely immediately, supporting sustained revenue streams.

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4. Key Comparative Analysis

Characteristic	Trelegy Ellipta	Breo Ellipta	Anoro Ellipta	Trimbow
Composition	FF + UMEC + VI	FF + VI	UME + VI	Beclometasone + Formoterol + GPI
Indications	COPD, asthma	COPD, asthma	COPD	COPD (Europe only)
Price (USD/month)	400	350	420	330
Global Market Share (2022)	25%	20%	10%	5%

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5. FAQs

Q1: What are the primary clinical benefits of Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate?
It provides triple-action therapy offering anti-inflammatory, bronchodilatory, and long-term symptom management, reducing exacerbation risk in COPD and asthma.

Q2: How does the clinical efficacy of this combination compare with dual therapies?
Clinical trials demonstrate superior lung function improvement (FEV1) and reduced exacerbations over dual therapies like FF/VI or UME/VI.

Q3: What are the main safety considerations?
Common adverse effects include oropharyngeal candidiasis, hoarseness, and nasopharyngitis. Long-term safety data remains favorable but continuous surveillance is ongoing.

Q4: What are the key regulatory challenges facing this drug?
Maintaining label approvals in emerging markets and addressing biosimilar competition post-patent expiry pose ongoing challenges.

Q5: Which markets present the greatest growth opportunities?
Asia-Pacific and Latin America are high-growth markets due to rising COPD prevalence and expanding healthcare infrastructure.

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6. Key Takeaways

• Clinical Development: The combination drug maintains a strong clinical evidence base, with ongoing trials expanding its indications and long-term safety profile.
• Market Position: Trelegy Ellipta dominates the triple-inhaler COPD segment with over USD 2.2 billion in annual sales, supported by regulatory approvals and strategic market expansion.
• Growth Prospects: The global COPD market is projected to grow at a CAGR of over 4%, with Trelegy Ellipta expected to benefit from label expansion and increasing adoption, especially in emerging markets.
• Competitive Landscape: While competition intensifies from dual therapies and lower-cost alternatives, innovative clinical data and broader indications will sustain its market share.
• Future Focus: Stakeholders should monitor patent landscapes, regulatory changes, and market access policies to optimize commercial strategies.

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References

[1] IQVIA. (2022). Global COPD Market Data.
[2] GSK. (2022). Trelegy Ellipta Product Label & Clinical Data.
[3] GlobalData. (2022). Inhalation Therapy Market Analysis.
[4] ClinicalTrials.gov. (Various). Ongoing Clinical Trials for COPD Therapies.
[5] EMA & FDA Publications. (2017-2022). Regulatory Approvals & Label Updates.

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Note: Data and projections are based on current industry reports, clinical trial registries, and regulatory filings as of 2023.