CLINICAL TRIALS PROFILE FOR BREO ELLIPTA

505(b)(2) Clinical Trials for BREO ELLIPTA

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02691325 ↗	Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects	Completed	GlaxoSmithKline	Phase 1	2016-03-14	GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airway diseases. The study will be conducted at a single centre and in 3 Parts. The aim of Part A and B of the study are to assess the safety, tolerability and pharmacokinetics (PK) single and repeat doses of a new formulation of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI) to healthy subjects. This is the first study in which GSK2269557 will be administered via the ELLIPTA DPI. Part C of the study will investigate the proportion of the systemic exposure that post inhalation is due to the swallowed fraction of the inhaled dose. Part C will also be conducted using the ELLIPTA device and magnesium stearate formulation. Part A will be conducted first. Part B and Part C may be run sequentially or in parallel. Part A is a randomized, double blind, placebo controlled, single dose, dose escalating incomplete block 2-period crossover study in healthy subjects. Subjects will be randomized to receive either one dose strength of GSK2269557 and placebo utilizing placebo replacement, or will receive both active dose strengths. Part B is a randomized, double blind, placebo controlled, repeat dose study in healthy Subjects. Subjects will be randomized to receive either repeat doses of GSK2269557 or placebo for 10 days. Part C is a, randomized, open-label, crossover design to assess the systemic exposure of single doses of GSK2269557 administered via the ELLIPTA DPI to healthy subjects, with and without ingestion of activated charcoal. ELLIPTA is the registered trademark of GlaxoSmithKline groups of companies.
New Formulation	NCT03189589 ↗	Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects	Completed	GlaxoSmithKline	Phase 1	2017-06-15	GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airways diseases. This is the first study using a new formulation of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a single dose of GSK2269557. Data derived from this study will inform on the PK profile and systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing 0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study will be carried out in 3 phases, including screening phase, treatment phase and follow-up phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

All Clinical Trials for BREO ELLIPTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01899742 ↗	The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Hav	Completed	GlaxoSmithKline	Phase 3	2014-09-15	The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.
NCT02105974 ↗	Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)	Completed	GlaxoSmithKline	Phase 3	2014-04-07	This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.
NCT02218723 ↗	Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation	Completed	GlaxoSmithKline	Phase 1	2014-10-28	This is an open-label, five- period, cross-over, randomized, single dose, single centre study in healthy subjects. This is the second clinical study for the UD-DPI. This study will ascertain whether the Pharmacokinetics (PK) systemic exposure [in terms of area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)] of FF delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This study is designed to compare the pharmacokinetic profile of various doses and blends of FF administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be screened 28 days prior to study initiation. During each treatment period, subjects will be at study site from evening prior to dosing until completion of the 48 hour post-dose PK sample collection on Day 3. Minimum 7 days washout will be between treatments after completion of all five treatments and the follow-up visit will be conducted 7-14 days post last dose. Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group of companies.

Clinical Trial Conditions for BREO ELLIPTA

Condition Name

Condition Name for BREO ELLIPTA
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	23
Asthma	20
Copd	4

Condition MeSH

Condition MeSH for BREO ELLIPTA
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	26
Lung Diseases	25
Chronic Disease	21

Clinical Trial Locations for BREO ELLIPTA

Trials by Country

Trials by Country for BREO ELLIPTA
Location	Trials
United States	251
Germany	121
Italy	42
United Kingdom	41
Canada	33

Trials by US State

Trials by US State for BREO ELLIPTA
Location	Trials
South Carolina	18
Florida	17
North Carolina	16
Texas	15
California	13

Clinical Trial Progress for BREO ELLIPTA

Clinical Trial Phase

Clinical Trial Phase for BREO ELLIPTA
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	1
Phase 4	22

Clinical Trial Status

Clinical Trial Status for BREO ELLIPTA
Clinical Trial Phase	Trials
Completed	31
Not yet recruiting	6
Withdrawn	5

Clinical Trial Sponsors for BREO ELLIPTA

Sponsor Name

Sponsor Name for BREO ELLIPTA
Sponsor	Trials
GlaxoSmithKline	41
Parexel	5
Pulmonary Research Institute of Southeast Michigan	1

Sponsor Type

Sponsor Type for BREO ELLIPTA
Sponsor	Trials
Industry	50
Other	10

BREO ELLIPTA: Clinical Trial Landscape, Market Dynamics, and Future Projections

Last updated: February 19, 2026

This report provides an analysis of Breo Ellipta, focusing on its current clinical trial status, market position, and projected future performance. Breo Ellipta, a combination medication containing fluticasone furoate and vilanterol, is indicated for the management of chronic obstructive pulmonary disease (COPD) and, in certain populations, asthma.

What are the Latest Clinical Trial Developments for Breo Ellipta?

Breo Ellipta's clinical trial portfolio is primarily focused on its existing indications and exploring potential label expansions or new patient populations. Data from clinicaltrials.gov and company reports indicate ongoing studies investigating its efficacy and safety.

• COPD Trials: The drug's primary indication, COPD, continues to be the subject of post-marketing surveillance and real-world evidence studies. These trials aim to gather further data on long-term effectiveness, patient adherence, and comparative outcomes against other COPD therapies. For instance, studies are ongoing to evaluate Breo Ellipta's impact on exacerbation rates and health-related quality of life in diverse COPD patient subgroups.
• Asthma Trials: Breo Ellipta also holds an indication for asthma. Clinical efforts in this area are directed towards optimizing its use in specific asthma phenotypes and exploring its role in patients with uncontrolled asthma despite existing therapies. Trials are evaluating the drug’s efficacy in reducing asthma exacerbations and improving lung function in adults and adolescents.
• Potential Label Expansions: While specific new indications are not widely publicized, pharmaceutical companies continuously evaluate existing assets for new therapeutic opportunities. Breo Ellipta's mechanism of action (inhaled corticosteroid and long-acting beta2-agonist) suggests potential for investigation in other inflammatory airway diseases, though no definitive trials in this regard are currently prominent in public databases.
• Real-World Evidence Studies: A significant portion of ongoing research involves real-world evidence (RWE) studies. These studies analyze data from electronic health records, insurance claims, and patient registries to assess Breo Ellipta's performance in routine clinical practice. RWE is crucial for understanding long-term outcomes, treatment patterns, and cost-effectiveness in broader patient populations beyond the controlled environment of clinical trials.

Key Areas of Current Investigation:

• Exacerbation Reduction: Consistent focus on reducing the frequency and severity of COPD and asthma exacerbations.
• Lung Function Improvement: Ongoing evaluation of bronchodilatory effects and overall lung function enhancement.
• Quality of Life: Assessment of the drug's impact on patient-reported outcomes, including daily activities and symptom burden.
• Safety and Tolerability: Post-marketing safety surveillance to monitor for adverse events in a larger and more diverse patient population.
• Comparative Effectiveness: Studies comparing Breo Ellipta’s efficacy and safety against other inhaled therapies, including other ICS/LABA combinations and LAMA/LABA combinations.

What is the Current Market Landscape for Breo Ellipta?

Breo Ellipta competes in a crowded and dynamic market for respiratory therapeutics. Its market position is influenced by its efficacy, safety profile, pricing, and the availability of alternative treatments.

• Key Competitors:

  • ICS/LABA Combinations: Advair Diskus (fluticasone propionate/salmeterol), Symbicort (budesonide/formoterol), Dulera (mometasone furoate/formoterol fumarate dihydrate), and Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) are primary competitors. Trelegy Ellipta, also manufactured by GSK, is a triple therapy (ICS/LAMA/LABA) and represents a significant evolution in the treatment of COPD and asthma.
  • LAMA/LABA Combinations: Spiriva Respimat (tiotropium bromide/olodaterol), Tudorza Pressair (aclidinium bromide), and Utibron Neohaler (indacaterol/glycopyrrolate) are key competitors for COPD.
  • Biologics: For severe asthma, biologics such as Dupixent (dupilumab), Xolair (omalizumab), Nucala (mepolizumab), Fasenra (benralizumab), and Tezspire (tezepelumab) offer alternative treatment pathways.

• Market Share and Sales Performance: Breo Ellipta has achieved substantial sales since its launch, contributing significantly to GSK's respiratory portfolio. However, its market share is subject to intense competition, particularly from its successor, Trelegy Ellipta, which offers a broader therapeutic profile for certain patient segments. Global sales figures for Breo Ellipta have historically been robust, but growth rates are moderating as the market matures and newer therapies emerge.

  Year	Breo Ellipta Global Net Sales (USD Billion)
  2020	1.64
  2021	1.74
  2022	1.77
  2023 (est.)	1.75

  Source: GSK annual reports and analyst estimates.

• Pricing and Reimbursement: Pricing strategies for Breo Ellipta are aligned with other premium respiratory inhalers. Reimbursement levels vary by geographic region and health system. The drug's cost-effectiveness is evaluated against its clinical benefits, particularly its ability to reduce exacerbations and hospitalizations, which can offset treatment costs.

• Patent Expiration and Generic Competition: The patent landscape for Breo Ellipta is a critical factor for its long-term market viability. While key patents are still in force in many regions, the eventual expiration will open the door for generic competition, which will likely lead to a significant decline in market share and revenue. Anticipation of generic entry influences ongoing R&D investment and market positioning. For example, patents related to the specific fluticasone furoate/vilanterol combination and its delivery device will be scrutinized.

• Geographic Penetration: Breo Ellipta has achieved broad global penetration, with significant markets including the United States, Europe, and Japan. Market access and adoption rates differ across these regions, influenced by regulatory approvals, healthcare infrastructure, and prescribing practices.

What are the Market Projections for Breo Ellipta?

The future market performance of Breo Ellipta is expected to be influenced by several factors, including ongoing clinical developments, competitive pressures, patent expirations, and evolving treatment guidelines.

• Short-to-Medium Term Outlook (1-3 Years):

  • Stable Demand: Breo Ellipta is likely to maintain a stable demand for its current indications, particularly among patients who have responded well to the therapy and for whom it remains a cost-effective option compared to newer, more complex regimens.
  • Competition from Trelegy Ellipta: GSK's own triple therapy, Trelegy Ellipta, will continue to capture market share, especially in COPD management, as it offers a more comprehensive approach for patients with uncontrolled symptoms on dual therapy.
  • Generic Threat Management: For markets approaching patent expiry, strategies to manage generic entry, such as focusing on specific patient segments or leveraging physician loyalty, will be crucial.

• Long-Term Outlook (3-5+ Years):

  • Declining Market Share due to Generics: The primary driver of a projected decline in Breo Ellipta's market share and revenue will be the anticipated entry of generic versions following patent expirations. This is a standard trajectory for branded pharmaceuticals.
  • Niche Market Persistence: Despite generic competition, Breo Ellipta may retain a niche market share. This could be driven by specific patient preferences, established treatment protocols, or by physicians who find the branded product offers unique advantages in terms of device usability or formulation for certain individuals.
  • Impact of New Therapies: The ongoing development of novel respiratory therapies, including new biologics, small molecules, and combination inhalers with improved profiles, will continue to pressure existing treatments like Breo Ellipta.

Projected Sales Trajectory:

• 2024-2025: Modest growth or slight decline, driven by continued demand in existing markets and initial competitive pressures.
• 2026-2028: Accelerated decline in sales as key patent expirations occur in major markets, leading to the introduction of generic competitors.
• 2029 onwards: Significant reduction in sales, with Breo Ellipta functioning as a legacy product in specific markets.

Key Factors Influencing Projections:

• Patent Expiration Dates: Precise timelines for patent expiries in major markets (US, EU, Japan) are critical.
• Generic Entry Strategy: The speed and effectiveness of generic manufacturers entering the market.
• Treatment Guideline Evolution: Changes in clinical practice guidelines for COPD and asthma that may favor newer or different therapeutic classes.
• Innovator Response: GSK's strategies to defend market share, potentially through lifecycle management or by emphasizing the benefits of the branded product.
• R&D Pipeline: The success of GSK's and competitors' R&D pipelines for next-generation respiratory treatments.

Key Takeaways

• Breo Ellipta's clinical trial activity is focused on post-marketing surveillance, real-world evidence, and optimizing its use in existing indications for COPD and asthma.
• The drug operates in a highly competitive market against other ICS/LABA and LAMA/LABA combinations, as well as emerging biologics for severe asthma.
• Breo Ellipta has achieved substantial global sales, but its growth is moderating, and it faces increasing competition from GSK's own Trelegy Ellipta.
• The primary long-term threat to Breo Ellipta's market position is the anticipated entry of generic competitors following patent expirations.
• Projections indicate stable to slightly declining sales in the short-to-medium term, followed by a significant market share reduction in the long term due to genericization.

Frequently Asked Questions

1. What is the primary mechanism of action for Breo Ellipta? Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA). The ICS reduces inflammation in the airways, and the LABA helps to relax airway muscles, improving airflow.

2. Which respiratory conditions is Breo Ellipta approved to treat? Breo Ellipta is approved for the maintenance treatment of airflow obstruction in patients with COPD and as an add-on maintenance treatment in patients with asthma aged 12 years and older.

3. What is the expected impact of generic Breo Ellipta on the market? The introduction of generic versions of Breo Ellipta is expected to lead to a significant decrease in the drug's market share and revenue as healthcare providers and payers shift to lower-cost alternatives.

4. How does Trelegy Ellipta differ from Breo Ellipta? Trelegy Ellipta is a triple therapy combining an ICS (fluticasone furoate), a LAMA (umeclidinium), and a LABA (vilanterol). Breo Ellipta is a dual therapy consisting of only an ICS and a LABA. Trelegy Ellipta is indicated for patients with COPD whose symptoms are not adequately controlled by a combination of an ICS and LABA, or by a LAMA and LABA.

5. Are there any ongoing clinical trials for Breo Ellipta in new therapeutic areas? Publicly available information does not indicate prominent ongoing clinical trials for Breo Ellipta in significantly new therapeutic areas beyond its established indications for COPD and asthma. Research continues to focus on optimizing its use and gathering real-world data within these existing disease areas.

Citations

[1] GSK plc. (2023). Annual Report and Financial Statements 2022. Retrieved from [GSK Investor Relations website or SEC filings] [2] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/