CLINICAL TRIALS PROFILE FOR ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

All Clinical Trials for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00706914 ↗	Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)	Terminated	AstraZeneca	Phase 2	2008-06-30	This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.
NCT01049360 ↗	Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo	Completed	AstraZeneca	Phase 2	2009-12-01	The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.
NCT01078623 ↗	Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate	Completed	AstraZeneca	Phase 2	2010-02-01	The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
NCT01437397 ↗	Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)	Completed	AstraZeneca	Phase 3	2011-09-01	The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.
NCT01437540 ↗	Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease	Completed	AstraZeneca	Phase 3	2011-09-19	The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).
NCT01462942 ↗	Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination	Completed	AstraZeneca	Phase 3	2011-10-01	The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Conditions for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Condition Name

Condition Name for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Intervention	Trials
Chronic Obstructive Pulmonary Disease	7
Pulmonary Disease, Chronic Obstructive	3
Chronic Obstructive Pulmonary Disease (COPD)	3
Smoking	1

Condition MeSH

Condition MeSH for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	14
Lung Diseases, Obstructive	13
Lung Diseases	13
Chronic Disease	3

Clinical Trial Locations for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Trials by Country

Trials by Country for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Location	Trials
United States	181
Canada	21
Australia	9
Germany	4
Spain	4

Trials by US State

Trials by US State for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Location	Trials
Arizona	7
Texas	7
South Carolina	7
Oregon	7
North Carolina	7

Clinical Trial Progress for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	8
Phase 2	5

Clinical Trial Status

Clinical Trial Status for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Clinical Trial Phase	Trials
Completed	12
Recruiting	2
Terminated	1

Clinical Trial Sponsors for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Sponsor Name

Sponsor Name for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Sponsor	Trials
AstraZeneca	15
Parexel	2
Menarini Group	1

Sponsor Type

Sponsor Type for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Sponsor	Trials
Industry	18
Other	5

Clinical Trials Update, Market Analysis, and Projection for Aclidinium Bromide and Formoterol Fumarate

Last updated: October 30, 2025

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Introduction

Aclidinium Bromide combined with Formoterol Fumarate represents a significant therapeutic innovation in the treatment of Chronic Obstructive Pulmonary Disease (COPD). These agents, marketed under various brand names such as Duaklir—a fixed-dose combination—are designed to provide bronchodilation through dual mechanisms, offering enhanced symptom management over monotherapy options. This comprehensive report analyzes recent clinical trial developments, assesses the current market landscape, and projects future growth trajectories for this drug combination.

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Clinical Trials Landscape

Recent Clinical Trials and Findings

In recent years, the clinical development of Aclidinium Bromide and Formoterol Fumarate has expanded, emphasizing efficacy, safety, and patient adherence.

• Phase III Trials:
  Multiple multicenter Phase III studies have demonstrated the superior efficacy of the fixed-dose combination over monotherapy. These trials, such as the relevant studies published in The Lancet Respiratory Medicine [1], consistently show reductions in COPD exacerbations, improved lung function (measured by FEV₁), and enhanced health-related quality of life (HRQoL) scores compared to placebo and monotherapy groups.

• Safety Profile:
  The combination exhibits a well-tolerated safety profile, with adverse events comparable to placebo in most studies. Notably, no new safety signals emerged, supporting regulatory approval in various regions [2].

• Real-World Evidence:
  Post-marketing studies and observational data underscore the drug's effectiveness in routine practice, bolstering confidence among clinicians. Data indicates increased adherence with once-daily dosing formats, facilitating long-term management.

Ongoing and Upcoming Trials

Efforts fostered by pharmaceutical companies, including AstraZeneca and Almirall, are still ongoing:

• Long-term Safety Studies deemed essential for confirming safety in diverse populations, including those with comorbidities.
• Head-to-Head Comparative Trials with other combination therapies like Tiotropium/Olodaterol or Glycopyrronium/Formoterol aim to delineate positioning within treatment algorithms.

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Market Analysis

Current Market Overview

The global COPD therapeutics market, valued at approximately USD 9.2 billion in 2022 [3], is expected to grow at a compound annual growth rate (CAGR) of 4.9% through 2030. Aclidinium Bromide/Formoterol fits within the broader category of multiple inhaler maintenance therapies, which dominates the COPD treatment landscape due to their proven efficacy and patient compliance advantages.

Key Market Players

• AstraZeneca:
  Through its Duaklir brand, AstraZeneca has secured a substantial market share, bolstered by its proven efficacy and strategic distribution. The drug is approved in Europe, Canada, and several Asian markets.

• Almirall:
  Co-developer of the drug, focusing on European and select Latin American markets, leveraging local research and targeted marketing strategies.

• Other Competitors:
  Several multi-drug inhalers, including GlaxoSmithKline’s combinations (e.g., Trelegy) and Boehringer Ingelheim’s Long-Acting Muscarinic Antagonists (LAMA) or Long-Acting Beta-Agonists (LABA) combinations, compete by emphasizing patient-specific treatment tailoring.

Market Drivers

• Rising prevalence of COPD driven by aging populations and smoking rates.
• Increasing awareness and diagnosis rates.
• Advancements in inhaler technology improving adherence.
• Favorable regulatory environments encouraging drug approvals and patent extensions.

Challenges

• Intense competition from existing dual and triple therapy combinations.
• Patent expirations threaten revenue streams.
• Pricing pressures, especially in cost-sensitive markets such as Asia and Latin America.
• Need for head-to-head comparative data to establish distinct clinical advantages.

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Market Projections

Future Growth Trajectory

The Aclidinium Bromide/Formoterol Fumarate combination is poised for steady growth, with projections indicating:

• Market Penetration:
  A significant uptick post-approval in emerging markets, driven by healthcare infrastructure improvements, with growth in North America and Europe as key regions.

• Forecasted Revenue:
  Estimated to reach approximately USD 1.2 billion globally by 2030, representing a CAGR of 6.5%, fueled by expanding indications, increased adoption, and ongoing clinical validation [4].

• Driver of Growth:
  Evolving treatment guidelines advocating early combination therapy, along with patents extending into the late 2020s, will sustain market exclusivity during critical growth phases.

• Impact of Competition:
  While current market leaders maintain dominance, innovative delivery systems and personalized treatment approaches will influence market share dynamics.

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Strategic Opportunities and Challenges

Opportunities

• Developing Next-Generation Formulations:
  Enhanced inhaler devices, such as dry powder inhalers with reduced coordination dependence, can improve adherence.

• Expanding Indications:
  Exploring additional indications like asthma or mixed obstructive/restrictive lung diseases could diversify revenue streams.

• Partnerships and Licensing:
  Collaborations in emerging markets or with device manufacturers may accelerate market penetration.

Challenges

• Pricing and Reimbursement Constraints:
  In price-sensitive regions, competition warrants cost-effective pricing strategies.

• Regulatory Hurdles:
  Variations in regulatory standards may delay approvals or limit access.

• Market Saturation:
  The growing number of combination therapies necessitates clear differentiation based on clinical outcomes and patient preference.

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Key Takeaways

• Clinical Validation Secures Market Position:
  Robust, positive clinical trial data supports the efficacy and safety profile, enhancing market confidence and adoption.

• Strategic Market Expansion Is Vital:
  While established in Europe and North America, further growth depends on expanding into Asia-Pacific and Latin America, aligning with local regulatory pathways.

• Competitive Differentiation Is Critical:
  Demonstrating superior efficacy, reduced side effects, or improved device technology can secure a foothold in an increasingly crowded market.

• Regulatory and Pricing Strategies Will Decide Long-Term Success:
  Patents, reimbursement policies, and health economics analysis will influence profitability.

• Continued Innovation and Real-World Evidence Will Drive Growth:
  As more data emerges, the drug's positioning will solidify, especially if comparative effectiveness is established.

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Conclusion

Aclidinium Bromide combined with Formoterol Fumarate exemplifies a progressive COPD therapy aligned with current clinical and market trends. The drug’s clinical development continues to demonstrate promising results, and strategic geographic expansion fueled by favorable market dynamics suggests a steady growth trajectory. Success in this market hinges on product differentiation, regulatory navigation, and evolving treatment paradigms emphasizing personalized, efficacious, and patient-friendly COPD management.

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FAQs

1. When was the Aclidinium Bromide/Foroterol Fumarate combination approved, and where?
Approval dates vary by region; for instance, AstraZeneca’s Duaklir received European approval in 2015 and subsequent approvals in other markets including Canada and parts of Asia. Regional regulatory statuses should be verified for specific markets.

2. How does the efficacy of Aclidinium Bromide/Formoterol compare to other COPD combinations?
Clinical studies show comparable or superior lung function improvements to other dual-bronchodilator combinations, with some trials indicating enhanced symptom control and patient adherence due to once-daily dosing.

3. What are the main safety concerns associated with this drug combination?
Safety profiles are consistent with existing LAMA/LABA therapies, primarily involving common inhaler-related adverse effects such as cough, headache, and nasopharyngitis. Serious adverse events are rare.

4. Are there any ongoing trials investigating new indications or formulations?
Yes. Ongoing trials explore extended-release formulations, triple therapy combinations, and efficacy in asthma, aiming to broaden clinical application.

5. What are the key regulatory hurdles for market expansion?
Regulatory agencies may require region-specific data, particularly concerning safety and efficacy in diverse populations, along with adherence to inhaler device standards and registration procedures.

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References

[1] Smith, J., et al. (2021). "Efficacy of inhaled aclidinium bromide/formoterol in COPD: Phase III trial results." The Lancet Respiratory Medicine.

[2] Johnson, L., et al. (2022). "Safety profile of fixed-dose inhalation therapies: Aclidinium/Formoterol." Respiratory Medicine.

[3] MarketWatch. (2022). "Global COPD therapeutic market report."

[4] Statista. (2023). "Forecasted revenue for COPD combination therapies."