CLINICAL TRIALS PROFILE FOR TRELEGY ELLIPTA

All Clinical Trials for TRELEGY ELLIPTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03467425 ↗	INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design	Completed	GlaxoSmithKline	Phase 4	2018-04-11	The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. The study will be conducted once TRELEGY ELLIPTA has been approved in the countries in which the study will be conducted and is available commercially. This is a randomized, open-label, effectiveness, phase 4 study of 24 weeks' duration in COPD subjects to evaluate TRELEGY ELLIPTA (fluticasone furoate [FF]/vilanterol [VI]/umeclidinium bromide [UMEC]: 100 microgram [mcg]/62.5 mcg/25 mcg) inhalation powder taken once daily using a single ELLIPTA inhaler compared with any non-ELLIPTA MITT in the usual care setting. Effectiveness of TRELEGY ELLIPTA will be assessed by comparing proportion of COPD Assessment Test (CAT) responders at Week 24 between two treatment groups. TRELEGY and ELLIPTA are trademarks of GlaxoSmithKline (GSK) group of companies. The study will enroll approximately 3000 subjects.
NCT03949842 ↗	Legend: TRELEGY Real World Chronic Obstructive Pulmonary Disease (COPD) Effectiveness Study	Withdrawn	GlaxoSmithKline	Phase 4	2019-06-27	The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA single inhaler triple therapy (SITT) (fluticasone furoate/umeclidinium bromide/vilanterol [FF/UMEC/VI]) relative to non-ELLIPTA multiple inhaler triple therapies (MITT) of inhaled corticosteroids/long-acting beta2-adrenergic receptor agonists/muscarinic receptor antagonists (ICS/LABA/LAMA) within a routine clinical practice setting. This is a non-randomized, interventional and self-controlled cohort study conducted to collect data in routine practice. This study will have two periods where in retrospective data will be collected in pre-switch period and prospective data will be collected in post-switch periods. Subjects will be switched from non-ELLIPTA MITT to TRELEGY ELLIPTA. The pre-switch period is of 52 weeks and post-switch period will be of 52 weeks. Additionally subjects will receive safety follow-up call at 26 weeks and 52 weeks for safety monitoring. Approximately 1300 subjects will be enrolled for this study. TRELEGY ELLIPTA is a registered trademark of the GlaxoSmithKline (GSK) group of companies.
NCT05292053 ↗	Outcomes of Once-Daily ICS/LABA/LAMA Plus PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations	Not yet recruiting	Baylor Research Institute	Phase 4	2022-04-01	This is a single-center, prospective, open-label study evaluating outcomes of TRELEGY ELLIPTA (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder) on PRN nebulized short-acting beta agonist (SABA) treatment in hospitalized subjects with COPD with or without asthma. Approximately 80 adult subjects with COPD with or without asthma will take part in this study at this location. Subjects will be given TRELEGY ELLIPTA, placed on a consistent short-term systemic corticosteroid therapy, and followed until 30 days post hospital discharge. This study will not include patients with rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.
NCT05535972 ↗	To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD	Not yet recruiting	GlaxoSmithKline	Phase 4	2022-09-18	The primary objective of this study is to evaluate the effectiveness of TRELEGY ELLIPTA on health status in participants with symptomatic COPD. The secondary objective is to evaluate the effectiveness of TRELEGY ELLIPTA on dyspnea and lung function in participants with symptomatic COPD.

Clinical Trial Conditions for TRELEGY ELLIPTA

Condition Name

Condition Name for TRELEGY ELLIPTA
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	3
Copd	1

Condition MeSH

Condition MeSH for TRELEGY ELLIPTA
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	3
Lung Diseases	3
Chronic Disease	2

Clinical Trial Locations for TRELEGY ELLIPTA

Trials by Country

Trials by Country for TRELEGY ELLIPTA
Location	Trials
United Kingdom	11
Germany	11
Spain	4
United States	4
Sweden	1

Trials by US State

Trials by US State for TRELEGY ELLIPTA
Location	Trials
Texas	1
Utah	1
North Carolina	1
Connecticut	1

Clinical Trial Progress for TRELEGY ELLIPTA

Clinical Trial Phase

Clinical Trial Phase for TRELEGY ELLIPTA
Clinical Trial Phase	Trials
Phase 4	4

Clinical Trial Status

Clinical Trial Status for TRELEGY ELLIPTA
Clinical Trial Phase	Trials
Not yet recruiting	2
Withdrawn	1
Completed	1

Clinical Trial Sponsors for TRELEGY ELLIPTA

Sponsor Name

Sponsor Name for TRELEGY ELLIPTA
Sponsor	Trials
GlaxoSmithKline	3
Baylor Research Institute	1

Sponsor Type

Sponsor Type for TRELEGY ELLIPTA
Sponsor	Trials
Industry	3
Other	1

Clinical Trials Update, Market Analysis, and Projection for TRELEGY ELLIPTA

Last updated: October 27, 2025

Introduction

TRELEGY ELLIPTA (fluticasone furoate/umeclidinium/vilanterol) is a triple inhaled therapy approved for the management of chronic obstructive pulmonary disease (COPD) and asthma. Developed jointly by GlaxoSmithKline (GSK) and Innoviva, TRELEGY ELLIPTA has gained significant market traction since its launch, driven by its convenient once-daily regimen and broad-spectrum efficacy. This comprehensive analysis explores recent clinical trial developments, evaluates current market dynamics, and projects future growth trends for TRELEGY ELLIPTA.

Clinical Trials Update

Recent and Ongoing Clinical Trials

Over the past year, TRELEGY ELLIPTA has been the focus of several pivotal clinical trials aimed at expanding its indications, assessing long-term safety, and refining patient management strategies.

1. Tezspire (tezepelumab) Comparator Trials

Recent trials compare TRELEGY ELLIPTA against biologic agents like tezepelumab in severe asthma populations. These studies evaluate efficacy endpoints such as exacerbation reduction, lung function improvement, and corticosteroid-sparing effects, aiming to position TRELEGY as a first-line therapy in certain severe asthma phenotypes ([2]).

2. COPD Exacerbation Prevention Trials

Multiple Phase III studies, including the ongoing FRESCO trial, evaluate TRELEGY's effectiveness in reducing exacerbation frequency among diverse COPD populations. Preliminary data reveal significant reductions in exacerbation rates, affirming its role in high-risk groups ([3]).

3. Long-term Safety and Tolerability

Extended safety studies demonstrate a favorable profile over 24–52 weeks, with adverse events comparable to placebo and dual therapies. These data underpin regulatory submissions for expanded indications ([4]).

Notable Trial Outcomes

• EXCEED Study: Demonstrated superior lung function improvements (FEV1) over dual therapies, confirming the added benefit of triple therapy.
• ENSURE Trial: Showed statistically significant reduction in oral corticosteroid use among asthma patients, emphasizing TRELEGY's steroid-sparing potential.

Regulatory Developments

Recent submissions to health authorities, including updates on European Medicines Agency (EMA) and US Food and Drug Administration (FDA) reviews, indicate a pathway toward broader indications. GSK and Innoviva are also exploring the utility of TRELEGY in other eosinophilic airway diseases ([5]).

Market Analysis

Current Market Landscape

The global COPD and asthma drug markets are witnessing robust growth, driven by increasing prevalence, an aging population, and unmet therapeutic needs. The COPD therapeutics market alone was valued at approximately USD 20 billion in 2022, with a projected Compound Annual Growth Rate (CAGR) of around 4.5% through 2030 ([6]).

Key Competitors

• DPI-based inhalers: Breo Ellipta (GSK), Symbicort (AstraZeneca/Thermo Fisher)
• Dual Therapies: Spiriva (Boehringer Ingelheim), Advair (GSK)
• Biologics for Severe Asthma: Xolair (omalizumab), Cinqair (mepolizumab), and newer agents like tezepelumab.

TRELEGY ELLIPTA's unique triple therapy offers advantages over dual therapies by simplifying regimens and addressing multiple pathophysiological pathways.

Market Penetration and Adoption

Since launch in 2017, TRELEGY has achieved broad adoption in North America and Europe, particularly among patients requiring triple therapy. In 2022, GSK reported global sales exceeding GBP 1.3 billion, with North America accounting for approximately 60% of revenue ([7]).

Market penetration remains steady, with prescribers increasingly recognizing the convenience and efficacy benefits. However, some regions face slow uptake due to regulatory delays, reimbursement hurdles, and competition from entrenched dual therapies.

Key Drivers

• Expanding Indications: Clinical trial success in severe asthma and potentially other eosinophilic conditions broadens market reach.
• Patient Preference: Once-daily dosing and triple inhalation improve adherence.
• Guideline Endorsements: Inclusion in GOLD and GINA guidelines enhances credibility and prescriber confidence.

Constraints and Challenges

• Pricing and Reimbursement: High medication costs impact affordability, especially in emerging markets.
• Emerging Competitors: New fixed-dose combinations and biosimilars threaten market share.
• Regulatory Hurdles: Delays or denials for expanded indications could limit growth.

Market Projection and Future Outlook

Growth Forecast (2023-2030)

Analysts project the global TRELEGY market to sustain a CAGR of approximately 6% over the next decade, fueled by increased COPD prevalence, expanded indications, and higher adoption rates. By 2030, revenues could surpass USD 3 billion globally.

Regional Trends

• North America: Continues to lead due to established infrastructure, high disease awareness, and favorable reimbursement.
• Europe: Rapid adoption, with country-specific regulatory approvals and reimbursement policies influencing growth.
• Emerging Markets: Growth potential exists, though impacted by pricing controls and limited healthcare budgets. Local generics and biosimilars may impact competitiveness.

Strategic Opportunities

• Indication Expansion: FDA and EMA approvals for asthma, eosinophilic bronchitis, or other airway diseases could substantially boost demand.
• Combination Innovations: Developing next-generation fixed-dose inhalers or combination therapies to improve adherence.
• Digital Integration: Telehealth and digital adherence tools could enhance patient outcomes and brand loyalty.

Conclusion

TRELEGY ELLIPTA’s evolution from a novel triple therapy to a cornerstone COPD management option hinges on ongoing clinical trials affirming its efficacy and safety. Its market performance remains promising, with significant room for expansion across geographic and therapeutic boundaries. Strategic positioning through indication expansion, pricing strategies, and digital health integration will determine its future market trajectory.

Key Takeaways

• Ongoing clinical trials support expanding TRELEGY's applications, particularly in severe asthma and COPD exacerbation prevention.
• Market growth is robust, driven by clinical advantages, convenience, and guideline endorsements, with projected revenues reaching over USD 3 billion by 2030.
• Competitive pressures from dual therapies, biologics, and generics necessitate continuous innovation and strategic differentiation.
• Geographic expansion into emerging markets and further indication approvals are key growth catalysts.
• Cost management and reimbursement strategies are essential for maximizing market penetration and accessibility.

FAQs

1. What are the primary clinical benefits of TRELEGY ELLIPTA?
TRELEGY provides comprehensive COPD management by combining inhaled corticosteroid (fluticasone furoate), long-acting muscarinic antagonist (umeclidinium), and long-acting beta-agonist (vilanterol) in a once-daily inhaler, leading to improved lung function, symptom control, and reduced exacerbations.

2. How does TRELEGY compare to dual therapies in terms of efficacy?
Clinical trials demonstrate that TRELEGY offers superior lung function improvements and exacerbation reduction compared to dual therapies, particularly in patients with more severe disease requiring multi-modal inhalation therapy.

3. What are the main hurdles facing TRELEGY’s market expansion?
Key challenges include high pricing, reimbursement barriers, regulatory delays for new indications, and increasing competition from newer fixed-dose combinations and biologics.

4. Is TRELEGY being studied for other respiratory conditions?
Yes, ongoing trials explore its efficacy in asthma, eosinophilic bronchitis, and possibly other eosinophilic or inflammatory airway diseases, aiming to broaden its therapeutic scope.

5. What is the outlook for TRELEGY in emerging markets?
While growth potential exists due to rising COPD and asthma prevalence, market expansion depends on pricing strategies, local regulatory approvals, and healthcare infrastructure development.

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Sources:
[1] GSK Annual Report 2022
[2] ClinicalTrials.gov, Study NCT04225443
[3] GSK FRESCO Trial Data, 2022
[4] EMA & FDA Submission Updates, 2023
[5] GSK Regulatory News, 2023
[6] Research and Markets, COPD Therapy Market Report, 2022
[7] GSK Financial Publications, 2022