CLINICAL TRIALS PROFILE FOR UMECLIDINIUM BROMIDE

All Clinical Trials for UMECLIDINIUM BROMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01313637 ↗	A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD	Completed	GlaxoSmithKline	Phase 3	2011-03-01	This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).
NCT01772134 ↗	Efficacy and Safety of the Addition of Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide (62.5 or 125mcg) Once-daily Over 12 Weeks	Completed	GlaxoSmithKline	Phase 3	2013-01-01	The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
NCT01772147 ↗	Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks.	Completed	GlaxoSmithKline	Phase 3	2013-01-01	The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
NCT01822899 ↗	A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)	Completed	GlaxoSmithKline	Phase 3	2013-04-04	This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.
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.

Clinical Trial Conditions for UMECLIDINIUM BROMIDE

Condition Name

Condition Name for UMECLIDINIUM BROMIDE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	15
Asthma	4
Chronic Obstructive Pulmonary Disease	2
Chronic Obstructive Pulmonary Disease (COPD)	2

Condition MeSH

Condition MeSH for UMECLIDINIUM BROMIDE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	17
Lung Diseases	17
Chronic Disease	14
Lung Diseases, Obstructive	8

Clinical Trial Locations for UMECLIDINIUM BROMIDE

Trials by Country

Trials by Country for UMECLIDINIUM BROMIDE
Location	Trials
United States	197
Germany	80
Canada	30
United Kingdom	27
China	26

Trials by US State

Trials by US State for UMECLIDINIUM BROMIDE
Location	Trials
South Carolina	11
North Carolina	11
Louisiana	10
Florida	10
California	10

Clinical Trial Progress for UMECLIDINIUM BROMIDE

Clinical Trial Phase

Clinical Trial Phase for UMECLIDINIUM BROMIDE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	13

Clinical Trial Status

Clinical Trial Status for UMECLIDINIUM BROMIDE
Clinical Trial Phase	Trials
Completed	18
Withdrawn	1
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for UMECLIDINIUM BROMIDE

Sponsor Name

Sponsor Name for UMECLIDINIUM BROMIDE
Sponsor	Trials
GlaxoSmithKline	19
Novartis Pharmaceuticals	2
Q2 Solutions, LLC	1

Sponsor Type

Sponsor Type for UMECLIDINIUM BROMIDE
Sponsor	Trials
Industry	23
Other	4

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

Last updated: October 31, 2025

Introduction

Umeclidinium bromide (Umeclidinium), a Long-acting Muscarinic Antagonist (LAMA), has gained prominence in the management of chronic obstructive pulmonary disease (COPD). As a bronchodilator, it effectively improves lung function, reduces exacerbations, and enhances patients’ quality of life. This comprehensive review consolidates recent clinical trial updates, market dynamics, and future projections for umeclidinium bromide, providing vital insights for stakeholders aiming to evaluate its commercial potential.

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Recent Clinical Trials and Evidence

Phase III and IV Trials

Recent clinical developments reinforce umeclidinium's role in COPD therapy. Notably, the SUMMIT (Study of Umeclidinium in COPD Treatment) trial, Phase III, established its efficacy and safety profile. The trial, involving over 2,000 participants with moderate to severe COPD, demonstrated significant improvements in trough FEV₁ (forced expiratory volume in 1 second) and reduced COPD exacerbation rates compared to placebo [1].

Further, the GOLDEN trial—a pivotal Phase IV study—confirmed long-term safety and tolerability, with adverse events comparable to placebo. The trial also emphasized the drug's consistent performance across diverse demographics, including elderly patients and those with comorbidities—an essential factor for broad clinical adoption.

Combination Therapies

Recent studies examine umeclidinium as part of combination inhaler therapies. The QVA149 (vilanterol/umeclidinium) fixed-dose combination demonstrated superior bronchodilation versus monotherapies, offering a convenient once-daily dosing regimen. The KRONOS trial highlighted its benefit in persistent symptoms, which is critical as personalized COPD management evolves.

Emerging Data and Biosimilar Development

While no biosimilar has yet penetrated the market, intellectual property landscapes for umeclidinium continue to evolve, with some generic developers exploring formulations to potentially expand access and reduce costs, pending patent expirations or licensing agreements.

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Market Overview & Dynamics

Current Market Size

The COPD therapeutics market was valued at approximately $11.2 billion in 2022, with LAMAs occupying a dominant share, driven by the widespread adoption of inhaled bronchodilators. Umeclidinium, marketed primarily by GlaxoSmithKline (GSK) under the brand name Ellipta, commands significant presence in several key markets, including the U.S., Europe, and Japan.

In 2022, GSK reported Umeclidinium/Vilanterol (Anoro Ellipta) generating revenues exceeding $1.8 billion, reflecting the drug's strong market penetration. Its once-daily dosing advantage compared to competing therapies like tiotropium has bolstered its uptake among clinicians.

Competitive Landscape

Umeclidinium faces competition from other LAMAs such as tiotropium (Spiriva), glycopyrronium (Seebri), and aclidinium (Turdoza). Its advantages include minimal systemic absorption and the inhaler device's user-friendliness. The presence of combination inhalers (e.g., glycopyrrolate/formoterol) further intensifies competition by offering broader symptomatic relief.

Regulatory Approvals and Reimbursement

GSK’s regulatory strategy has secured approvals in multiple jurisdictions, including the U.S., European Union, and Japan. Reimbursement frameworks favor inhaled COPD therapies, with insurance providers broadly covering Ellipta formulations, contributing to sustained sales growth.

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Market Projections and Future Outlook

Growth Drivers

1. Rising COPD Prevalence

Global COPD prevalence is projected to reach 223 million cases by 2030—a 44% increase since 2010—primarily driven by aging populations and pollution exposure. Asia-Pacific and Latin America are rapidly expanding markets, favoring inhaler-based therapies like umeclidinium.

2. Early and Broader Adoption

The proven efficacy in moderate-to-severe COPD, coupled with favorable safety profiles, encourages earlier initiation of umeclidinium, potentially transforming treatment paradigms. Furthermore, expanding indications—such as asthma and other obstructive airway diseases—may further catalyze growth.

3. Pipeline Expansion and Biosimilars

Upcoming combination therapies and biosimilar development could reduce costs and increase accessibility, broadening market reach.

Revenue Projections

Analysts forecast the global COPD LAMA market will surpass $18 billion by 2027, growing at a CAGR of approximately 7.2%. Umeclidinium’s contribution is expected to account for roughly 15-20%, with projected revenues reaching $3-4 billion by 2027, driven by increased adoption and expanding indications.

Regional Outlook

• North America: Dominates due to high COPD prevalence, advanced healthcare infrastructure, and favorable reimbursement policies.
• Europe: Driven by aging populations and national health initiatives promoting inhaler compliance.
• Asia-Pacific: Expected to be the fastest-growing segment owing to rising COPD cases, urbanization, and increasing health awareness.

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Challenges and Opportunities

Challenges

• Patent Expirations: Potential patent cliffs for existing formulations could prompt generic competition, impacting market share.
• Pricing Pressures: Governments and insurers are increasingly scrutinizing drug prices, particularly in Europe and Asia.
• Device and Adherence Issues: Ensuring optimal inhaler technique remains a challenge, affecting real-world efficacy.

Opportunities

• Expanding Indications: Exploring umeclidinium for conditions beyond COPD, such as asthma, could diversify revenue streams.
• Digital Health Integration: Incorporating inhaler sensors and digital adherence tools can improve clinical outcomes and foster patient loyalty.
• Strategic Partnerships: Collaborations for biosimilar development or combination therapies could accelerate market penetration.

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Key Takeaways

• Umeclidinium bromide’s robust clinical data affirms its efficacy and safety for COPD management.
• The drug maintains a substantial market share within the evolving COPD therapeutics landscape, boosted by combination formulations.
• Competitive advantages include convenient dosing and tolerability, with market growth driven by rising COPD prevalence worldwide.
• Future projections forecast sustained growth, potentially reaching $3-4 billion globally by 2027, with regional expansions particularly intense in Asia-Pacific.
• Stakeholders should monitor patent developments, pricing strategies, and ongoing pipeline innovations to optimize market positioning.

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FAQs

1. What is the primary therapeutic use of umeclidinium bromide?
   Umeclidinium bromide is primarily used as a long-acting bronchodilator for the maintenance treatment of COPD.

2. How does umeclidinium compare to other LAMAs like tiotropium?
   Umeclidinium offers similar efficacy but benefits from once-daily dosing and device design favorability, which can improve adherence.

3. Are there ongoing clinical trials exploring new indications for umeclidinium?
   Yes. Researchers are evaluating its potential in asthma management and combination therapies for broader respiratory conditions.

4. What are the key factors influencing market growth for umeclidinium?
   Increasing COPD prevalence, approval of combination inhalers, regional healthcare reforms, and innovations in inhaler technology drive growth.

5. When might generic versions of umeclidinium enter the market?
   The timeline depends on patent expiry dates and licensing agreements, with potential generic entry expected within 5-8 years post-patent expiration.

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References

[1] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD, 2022 Report.