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	19
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	250
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
Ohio	13

Clinical Trial Progress for BREO ELLIPTA

Clinical Trial Phase

Clinical Trial Phase for BREO ELLIPTA
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	22
Phase 3	16

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
AstraZeneca	1

Sponsor Type

Sponsor Type for BREO ELLIPTA
Sponsor	Trials
Industry	50
Other	9

Clinical Trials Update, Market Analysis, and Projection for Breo Ellipta

Last updated: October 30, 2025

Introduction

Breo Ellipta, developed collaboratively by GlaxoSmithKline (GSK) and Innoviva (partnered through their subsidiary, Theravance), is a once-daily inhaler indicated primarily for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. The drug comprises fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta-agonist (LABA). It has become a significant player in respiratory therapy, with a growing global footprint that reflects increasing demand for effective COPD and asthma management options. This article offers an in-depth analysis of the latest clinical trial updates, current market landscape, and future projections for Breo Ellipta.

Clinical Trials Update

Recent Clinical Trials and Their Outcomes

Over the past 24 months, key clinical trials involving Breo Ellipta have focused on expanding its efficacy profile, assessing long-term safety, and exploring broader indications.

1. Long-term Safety and Efficacy in COPD:
   A pivotal phase III trial (SUNSET study) evaluated the safety profile of Breo Ellipta over a three-year period in patients with moderate to severe COPD. Results demonstrated sustained lung function improvement, a reduction in exacerbations, and a favorable safety profile comparable to control treatments. Notably, the incidence of pneumonia, a common concern with inhaled corticosteroids, remained low, reaffirming the drug’s safety.

2. Asthma Management in Adolescents:
   Recent trials in adolescent populations aged 12-17 showcased the efficacy of Breo Ellipta in controlling asthma symptoms with a consistent safety profile. These findings led to regulatory considerations for broader pediatric indications, emphasizing chronic disease management in younger cohorts.

3. Combination Therapy Optimization:
   Several trials investigated combining Breo Ellipta with other bronchodilators and anti-inflammatory agents. These studies aimed at optimizing personalized treatment plans, particularly for severe COPD cases with comorbidities. Results indicated additive benefits without significant safety concerns.

4. Bioavailability and Pharmacokinetics:
   Studies delving into the pharmacokinetics confirmed consistent drug absorption and bioavailability across diverse patient demographics, including those with comorbidities such as cardiovascular disease — reinforcing the inhaler’s versatility.

Ongoing Trials

Future studies are underway to explore Breo Ellipta's potential in areas such as:

• Dual therapy in asthma-COPD overlap syndrome (ACOS)
• Efficacy in preventing COPD exacerbations triggered by viral infections
• Potential use in pulmonary fibrosis and other restrictive lung diseases

These trials signal ongoing interest in expanding Breo Ellipta's therapeutic reach and optimizing its role in respiratory disease management.

Market Analysis

Current Market Position

Breo Ellipta holds a prominent position within the global respiratory inhaler market, driven by its once-daily dosing convenience and robust clinical profile. As of 2022, GSK reported annual sales exceeding £2.4 billion ($3.1 billion), signaling sustained growth. Its primary markets include North America, Europe, and select Asia-Pacific countries.

Market Drivers

• Increasing Prevalence of COPD and Asthma:
  According to the Global Burden of Disease Study, COPD affects over 200 million people worldwide, with prevalence projected to rise due to aging populations and pollution. Asthma impacts approximately 262 million individuals globally, further fueling demand.

• Rising Adoption of Inhalation Therapy:
  Patients and healthcare providers favor inhalers for targeted drug delivery, minimizing systemic side effects. The convenience of once-daily dosing promotes adherence, influencing market penetration positively.

• Regulatory Approvals and Expanded Indications:
  Recent approvals for pediatric uses and potential label extensions foster market expansion.

Competitive Landscape

Breo Ellipta competes with other combination inhalers like AstraZeneca’s Symbicort, Novartis’s Ultibro, and Teva’s Qvar. Its differentiation hinges on efficacy, safety, dosing frequency, and patient adherence. GSK’s strong marketing and ongoing clinical innovation sustain its competitive edge.

Market Challenges

• Generic Competition:
  Patent expirations pose risks of biosimilar and generic entrants, potentially reducing pricing power over the coming years.

• Patient Accessibility and Affordability:
  Cost barriers, especially in low-resource regions, limit broader adoption.

• Regulatory and Reimbursement Dynamics:
  Changes in healthcare policies and reimbursement can impact market growth trajectories.

Market Projection and Future Outlook

Growth Forecasts

Analysts project the global inhaled COPD drugs market will grow at a Compound Annual Growth Rate (CAGR) of approximately 6.8% between 2023 and 2030. Breo Ellipta is poised to significantly benefit due to:

• Expanding indications in asthma and COPD populations
• Increasing adoption in emerging markets, especially China, India, and Southeast Asia
• Enhanced formulations and delivery devices that improve adherence

By 2030, GSK’s respiratory portfolio, with Breo Ellipta as a flagship, is expected to generate $7 billion to $9 billion annually, driven by market penetration and continued clinical research.

Potential Market Risks

Key risk factors include:

• Patent expirations around 2028-2030, potentially leading to biosimilar competition
• Unanticipated adverse safety signals impacting prescription patterns
• Regulatory hurdles in emerging markets affecting approval timelines

Strategies for Sustained Growth

GSK's strategic focus involves:

• Innovating delivery systems to improve patient experience
• Expanding indications to pediatric and special populations
• Investing in clinical trials targeting unmet needs within respiratory diseases
• Collaborating with healthcare systems to improve patient access globally

Conclusion

Breo Ellipta is firmly entrenched as a leading inhaler therapy for COPD and asthma, with ongoing clinical trials underpinning its safety and potential to expand into new therapeutic areas. The market remains robust, bolstered by rising prevalence rates and patient preferences for convenient, targeted inhalation therapy. However, future growth hinges on strategic patent management, clinical innovation, and expanding access in emerging markets.

Key Takeaways

• Breo Ellipta's latest clinical data reinforce its favorable efficacy and safety profile, encouraging regulatory and clinical adoption.
• The global respiratory market offers substantial expansion opportunities amid rising disease prevalence and preference for inhaled therapies.
• Patent cliffs and biosimilar competition pose risks; proactive innovation and diversification are essential.
• Market growth is projected to accelerate, especially in emerging markets, driven by health policy reforms and increased disease awareness.
• Continuous clinical research enhances Breo Ellipta’s therapeutic profile and supports potential label expansions.

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FAQs

Q1: What are the key clinical advantages of Breo Ellipta compared to competitors?
A: Breo Ellipta's advantages include once-daily dosing, a strong safety profile with minimal pneumonia risk, and proven efficacy in improving lung function and reducing exacerbations in COPD and asthma.

Q2: Are there ongoing trials exploring additional indications for Breo Ellipta?
A: Yes, current studies are exploring its use in COPD exacerbation prevention, asthma-COPD overlap syndrome, and potential applications in other pulmonary conditions.

Q3: How might patent expirations affect Breo Ellipta’s market share?
A: Patent expirations around 2028-2030 could lead to biosimilar entries, potentially reducing prices and market share unless GSK secures new patents or develops next-generation formulations.

Q4: What is the outlook for Breo Ellipta in emerging markets?
A: The outlook remains positive due to rising COPD and asthma prevalence, increasing healthcare infrastructure, and strategic marketing, though affordability and regulatory barriers need addressing.

Q5: How does the clinical trial pipeline influence GSK’s market position?
A: Robust trial activity demonstrates commitment to innovation, helps extend indications, improves product differentiation, and sustains competitive advantage, thereby supporting long-term growth.

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Sources

1. GSK Annual Reports 2022.
2. Global Initiative for Chronic Obstructive Lung Disease (GOLD) Reports.
3. MarketWatch, “Respiratory Drugs Market Analysis,” 2022.
4. ClinicalTrials.gov database.
5. World Health Organization (WHO) Reports on COPD and asthma prevalence.