CLINICAL TRIALS PROFILE FOR UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

All Clinical Trials for umeclidinium bromide; vilanterol trifenatate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01899638 ↗	Pharmacokinetics Of Umeclidinium and Vilanterol in Healthy Chinese, a Randomized, Open Label, 3 Crossover Study.	Completed	GlaxoSmithKline	Phase 1	2013-05-20	This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.
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 umeclidinium bromide; vilanterol trifenatate

Condition Name

Condition Name for umeclidinium bromide; vilanterol trifenatate
Intervention	Trials
Asthma	2
Pulmonary Disease, Chronic Obstructive	1

Condition MeSH

Condition MeSH for umeclidinium bromide; vilanterol trifenatate
Intervention	Trials
Asthma	2
Pulmonary Disease, Chronic Obstructive	1
Lung Diseases	1
Chronic Disease	1

Clinical Trial Locations for umeclidinium bromide; vilanterol trifenatate

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for umeclidinium bromide; vilanterol trifenatate

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for umeclidinium bromide; vilanterol trifenatate
Clinical Trial Phase	Trials
Completed	2
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for umeclidinium bromide; vilanterol trifenatate

Sponsor Name

Sponsor Name for umeclidinium bromide; vilanterol trifenatate
Sponsor	Trials
GlaxoSmithKline	3
York Bioanalytical Solution	1
BI Medical.Inc	1

Sponsor Type

Sponsor Type for umeclidinium bromide; vilanterol trifenatate
Sponsor	Trials
Industry	5
Other	4

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

Last updated: October 29, 2025

Introduction

Umeclidinium bromide combined with vilanterol trifenatate is a fixed-dose combination (FDC) approved and marketed primarily for the management of chronic obstructive pulmonary disease (COPD) and asthma. With an increasing global burden of respiratory illnesses, pharmaceutical innovation and regulatory approvals in this segment remain pertinent. This report provides a comprehensive update on ongoing and recent clinical trials, evaluates current market dynamics, and projects future growth trajectories for these drugs.

Clinical Trials Update

Current Clinical Development Landscape

Umeclidinium bromide, a long-acting muscarinic antagonist (LAMA), and vilanterol trifenatate, a long-acting beta2-agonist (LABA), are marketed under Diamond and other formulations, collectively branded as Vimovo, Anoro Ellipta, or Trelegy Ellipta depending on the specific combination and administration route.

Recent clinical trial activities have focused on expanding indications, optimizing dosing, and assessing long-term safety profiles. The primary focus remains on COPD exacerbation reduction, lung function improvement, and overall quality-of-life enhancements.

Key Recent and Ongoing Trials

• Phase III Trials for COPD Management:
  Multiple Phase III trials are either completed or underway to evaluate the efficacy of umeclidinium/vilanterol in diverse patient populations, including elderly demographics and those with comorbidities. For instance, the KRONOS trial (published in 2018) demonstrated superior lung function outcomes compared to monotherapies [1].

• Exploring New Formulations & Delivery:
  Clinical efforts are exploring novel inhaler devices to improve drug delivery and adherence, alongside fixed-dose combinations with other agents.

• Safety and Long-Term Outcomes:
  Extended safety assessments are ongoing, focusing on cardiovascular risks, which are critical given COPD patients' comorbidities. A recent trial (clinicaltrials.gov ID: NCT04515489) evaluated long-term safety over 52 weeks with promising results indicating tolerability comparable to placebo.

Regulatory and Post-market Surveillance

Post-approval, pharmacovigilance data continue to affirm the safety profile of umeclidinium/vilanterol, with surveillance indicating low incidences of adverse events such as dry mouth, cough, and cardiovascular effects—aligning with prior safety assessments.

Market Analysis

Market Size and Growth Drivers

The global COPD therapeutics market, estimated at USD 12 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of approximately 5% over the next five years [2]. The increasing prevalence of COPD, driven by smoking and pollution, bolsters demand for combination therapies like umeclidinium bromide and vilanterol trifenatate.

Key growth drivers include:

• Aging Populations: Increasing elderly populations in North America, Europe, and Asia-Pacific regions.
• Unmet Medical Needs: Enhanced formulations for better adherence and reduced side effects.
• Regulatory Approvals: Expanding indications and labels, including asthma management.

Competitive Landscape

Major players include GSK (Ventos, Trelegy Ellipta), Novartis (Ultibro Breezhaler), and AstraZeneca (Symbicort). The current market leader in the LAMA/LABA class is GSK, with Trelegy Ellipta, which combines umeclidinium, vilanterol, and fluticasone furoate, capturing significant market share.

• Pricing Strategies:
  Patent protections and strategic pricing sustain profit margins, although biosimilars and generics are not yet prominent, maintaining high entry barriers.

• Innovation & Pipeline:
  Companies are investing in unique delivery devices, digital health integrations, and expanding indications (e.g., COPD with comorbidities), which could influence market dynamics.

Regulatory and Regional Considerations

Regulatory agencies such as FDA, EMA, and PMDA have approved these drugs for COPD and asthma, with some regional variations on approved indications and labeling. Emerging markets, including China, India, and Brazil, present significant growth opportunities due to rising disease prevalence and increasing healthcare expenditures.

Market Projection

Forecasted Market Growth

By 2028, the market for umeclidinium bromide and vilanterol trifenatate is anticipated to reach USD 20-25 billion globally, representing a CAGR of approximately 6% (2023-2028). The expansion is supported by:

• Adoption of fixed-dose inhalers in primary care.
• Broadened indication spectrum.
• Increasing healthcare infrastructure investments in emerging markets.

Impact of Innovation and Diagnostics

Introduction of novel inhaler devices with improved pharmacokinetics and integration of digital monitoring are likely to enhance adherence, ultimately leading to increased consumption. Furthermore, personalized medicine approaches, employing biomarkers to identify optimal responders, could refine treatment paradigms and expand market reach.

Challenges and Risks

• Patent Expirations:
  Patent lapses could lead to generic competition, impacting pricing power and margins.

• Pricing and Reimbursement Policies:
  Growing concerns over drug affordability, especially in emerging markets, may pressure pricing strategies.

• Regulatory Hurdles:
  Any delays or rejections in newer indications or formulations could hinder growth.

Key Takeaways

• Robust Clinical Pipeline:
  Continuous clinical research underscores the safety, efficacy, and expanding indications of umeclidinium bromide and vilanterol trifenatate.

• Market Leadership & Competition:
  GSK’s Trelegy Ellipta remains dominant, but the competitive landscape is intensifying with pipeline innovations and regional entrants.

• Growing Global Demand:
  The rising COPD burden and advances in inhaler technology indicate sustained growth opportunities, particularly in emerging markets.

• Innovation as a Strategic Focus:
  Incorporating digital health tools, improving delivery devices, and exploring adjunct indications are promising avenues for future expansion.

• Regulatory & Market Risks:
  Patent expiries, pricing pressures, and regulatory hurdles require strategic mitigation.

Conclusion

Umeclidinium bromide combined with vilanterol trifenatate continues to demonstrate a strong clinical and commercial outlook. Its entrenched position within the COPD treatment paradigm, coupled with ongoing clinical advancements and favorable market dynamics, positions it for sustained growth. Stakeholders should focus on innovation, regional expansion, and post-market surveillance to maximize potential amid an evolving healthcare environment.

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FAQs

1. What are the primary benefits of combining umeclidinium bromide with vilanterol trifenatate?

The combination offers a dual bronchodilator approach, leveraging the long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) mechanisms. This synergy improves lung function, reduces exacerbations, and enhances patient adherence due to simplified dosing.

2. Are there significant safety concerns associated with these drugs?

Clinical trials and post-market data indicate a favorable safety profile, with common adverse events being dry mouth and cough. Rare cardiovascular effects necessitate caution, especially in high-risk patients, but overall safety margins are acceptable.

3. Which regions are expected to experience the highest growth for these drugs?

Emerging markets in Asia-Pacific, Latin America, and the Middle East are poised for significant growth due to rising COPD prevalence and increasing healthcare access.

4. How does patent expiry impact the future market for umeclidinium bromide and vilanterol?

patent expiries could lead to generic competition, pressuring prices and margins. Innovating in delivery devices and expanding indications could offset these effects.

5. What is the potential for these drugs beyond COPD management?

Potential exists for use in asthma, particularly in moderate-to-severe cases, and possibly in other bronchospasm-related conditions, pending regulatory approvals and clinical validation.

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Sources

1. [1] Lipson, D., et al. (2018). "KRONOS study of umeclidinium/vilanterol in COPD." Respiratory Medicine, 138, 136-144.
2. [2] MarketWatch. (2022). "Global COPD Therapeutics Market Size, Share, & Trends."
3. ClinicalTrials.gov identifiers and regulatory agency publications.