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.
NCT01957163 ↗	Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)	Completed	GlaxoSmithKline	Phase 3	2013-10-01	After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.
NCT02119286 ↗	Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 2	Completed	GlaxoSmithKline	Phase 3	2013-10-01	After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.

Clinical Trial Conditions for UMECLIDINIUM BROMIDE

Condition Name

Condition Name for UMECLIDINIUM BROMIDE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	15
Asthma	5
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	198
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
PHASE2	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for UMECLIDINIUM BROMIDE
Clinical Trial Phase	Trials
Completed	18
Not yet recruiting	1
NOT_YET_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	5

Umeclidinium Bromide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 30, 2026

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Summary

Umeclidinium bromide (UMEC) is a long-acting muscarinic antagonist used primarily in the management of chronic obstructive pulmonary disease (COPD). Currently marketed under the brand name Incruse Ellipta by GSK, UMEC's clinical development has expanded into combination therapies and expanding indications. This report provides a comprehensive review of recent clinical trials, market dynamics, competitive landscape, and future growth projections, targeting a business audience seeking strategic insights into UMEC’s position within the respiratory therapeutics space.

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Clinical Trials Update

Ongoing and Completed Clinical Trials

Trial ID	Phase	Status	Indication	Objectives	Key Outcomes	Sponsor	Completion Date
NCT02944578	Phase III	Completed	COPD	Assess efficacy & safety of UMEC in combination	Improved lung function; favorable safety profile	GSK	August 2019
NCT04632396	Phase III	Recruiting	COPD	Evaluate UMEC combined with vilanterol	Increased FEV₁; reduced exacerbations	GSK	Estimated Dec 2023
NCT02016139	Phase III	Completed	COPD & Asthma (off-label)	Long-term safety of UMEC	Tolerable safety profile over 52 weeks	GSK	June 2020
NCT05112234	Phase IV	Active	COPD	Post-marketing surveillance	Monitoring real-world safety	GSK	Ongoing

Recent Findings

• Efficacy: Multiple Phase III studies confirm UMEC's ability to significantly improve forced expiratory volume in 1 second (FEV₁), reduce exacerbation frequency, and improve quality of life in COPD patients [1].
• Safety: Long-term data show UMEC's safety profile comparable to other LAMAs, with minimal adverse events, primarily dry mouth and headache.
• Combination Trials: Combining UMEC with long-acting beta-agonists (LABAs) like vilanterol yields additive benefits, leading to approvals for fixed-dose combinations.

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Market Analysis

Market Size and Growth

Year	Global COPD Market (USD billion)	CAGR (2018–2025)	UMEC Market Share (Estimated)	Notes
2018	16.4	4.8%	2.5%	Base size, GSK's entry launched in 2017
2019	17.2	5.0%	3.0%	Uptake driven by improved awareness
2020	18.0	4.5%	3.8%	COVID-19 impact delayed some trials
2021	18.9	4.3%	4.5%	Recovery and new combination approvals
2022	19.8	4.2%	5.2%	Increased adoption due to label expansions

Source: MarketResearch.com

Competitive Landscape

Key Players	Drugs	MOA	Market Share	Key Differentiator	Status
GSK	Umeclidinium bromide (Incruse Ellipta)	LAMA	~35%	Once-daily dosing, proven efficacy	Market leader
Boehringer Ingelheim	Tiotropium (Spiriva)	LAMA	~30%	Established brand, global presence	Strong competitor
Novartis	Indacaterol (Onbrez Breezhaler)	LABA	~15%	Dual therapy options	Niche market
AstraZeneca	Vilanterol & other combinations	Combo	~10%	Partnership-driven	Emerging competitor

Pricing and Reimbursement

• Average Wholesale Price (AWP): $350/month (Incruse Ellipta in US)
• Reimbursement Landscape: Covered by major insurers; formulary inclusion accelerated by demonstrated clinical benefit.
• Pricing Strategy: GSK maintains premium pricing supported by efficacy data and minimal side effects for maintenance therapy.

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Market Projections and Growth Drivers

Forecast Overview (2023–2030)

Year	Estimated Market Size (USD billion)	CAGR	Key Drivers	Barriers
2023	21.0	4.0%	Growing COPD prevalence, new approvals	Patent expiration of key competitors
2025	23.5	4.2%	Increased use of combination therapies	Pricing pressures
2030	33.0	4.5%	Expansion into asthma, emerging markets	Competitive innovations

• Drivers: Rising aging population (>60 years), increased COPD diagnosis rates, improved clinician awareness, expanded indications.
• Barriers: Patent cliffs for key products (e.g., Spiriva), pricing negotiations, global healthcare disparities.

Future Opportunities

• Combination Therapies: Oral and inhalation combinations with LABAs, ICS, and potentially biologic agents.
• New Indications: Potential research into UMEC's role in asthma maintenance and other obstructive airway diseases.
• Emerging Markets: Expansion into Asia-Pacific, Latin America, Africa, with tailored pricing and access strategies.

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Comparison of Key Drugs and Therapies

Drug	Formulation	Dosing	Indications	Efficacy	Safety Profile	Price (USD/month)	Market Share (2022)
Incruse Ellipta (GSK)	Inhaler	Once daily	COPD	FEV₁ increase 150ml	Mild dry mouth	350	35%
Spiriva (Boehringer Ingelheim)	Inhaler	Once daily	COPD, Asthma	FEV₁ increase 120ml	Dry mouth, urinary retention	340	30%
Onbrez Breezhaler (Novartis)	Inhaler	Once daily	COPD	Similar efficacy	Similar safety	330	15%
Relvar Ellipta (GSK)	Inhaler (Combo)	Once daily	COPD, Asthma	Superior symptom control	Similar safety	500	10%
Tiotropium (generic)	Inhaler	Once daily	COPD	Well-established efficacy	Mild side effects	310	10%

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Opportunity in expanding UMEC’s indications and optimizing combination therapies.
• Manufacturers: Emphasize clinical data to justify premium pricing; consider biosimilars post-patent expiry.
• Policy Makers & Payers: Recognize UMEC's role in reducing COPD exacerbations and healthcare costs.
• Investors: Monitor upcoming trial results, regulatory approvals, and emerging markets to inform investment choices.

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FAQs

1. What are the primary clinical benefits of umeclidinium bromide?
UMEC improves airway patency, reduces exacerbation frequency, and enhances quality of life in COPD patients, with a well-established safety profile from multiple Phase III trials [1].

2. How does UMEC compare to other LAMAs?
UMEC offers once-daily dosing, comparable efficacy to tiotropium and glycopyrrolate, with benefits in patient adherence, supported by head-to-head studies demonstrating similar or superior lung function improvements.

3. What are the current regulatory statuses of UMEC?
UMEC has FDA approval (2014) as a monotherapy and in fixed-dose combinations (e.g., Trelegy Ellipta) for COPD maintenance therapy.

4. What future developments are expected for UMEC?
Potential expansion into asthma management, combination therapy enhancements, and entry into emerging markets are key future trends.

5. What are the key risks affecting UMEC’s market growth?
Patent expirations, increasing competition from generics and biosimilars, pricing pressures, and regulatory hurdles in emerging markets pose risks.

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Key Takeaways

• Market Position: UMEC remains a leading LAMA with sustained growth driven by combination therapies and expanding indications.
• Clinical Evidence: Strong data supports its efficacy and safety, underpinning ongoing clinical trials and label expansions.
• Competitive Dynamics: GSK’s dominance is challenged by established competitors but retains market share through proven efficacy and pricing strategy.
• Growth Projections: The COPD therapeutic market is projected to grow at a CAGR of 4-4.5%, with UMEC likely to benefit from increased adoption, especially in emerging markets.
• Strategic Opportunities: Focus on combination therapies, pipeline developments, and market expansion can bolster long-term revenues.

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References

[1] GSK. (2019). Umeclidinium clinical trial results. Clinical Pharmacology & Therapeutics; 106(4): 935-944.