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
COPD	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
Hungary	4
Czech Republic	4

Trials by US State

Trials by US State for Aclidinium Bromide; Formoterol Fumarate
Location	Trials
Texas	7
South Carolina	7
Oregon	7
North Carolina	7
Florida	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
QuintilesIMS, Inc.	1

Sponsor Type

Sponsor Type for Aclidinium Bromide; Formoterol Fumarate
Sponsor	Trials
Industry	18
Other	5

Aclidinium Bromide and Formoterol Fumarate: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Aclidinium bromide and formoterol fumarate, combined in the drug Duaklir Genuair (also known as Duaklir Pressair in some regions), represent a significant advancement in the treatment of chronic obstructive pulmonary disease (COPD). This article delves into the clinical trials, market analysis, and future projections for this combination therapy.

Clinical Trials Overview

Phase III Studies

The efficacy and safety of aclidinium bromide/formoterol fumarate have been extensively evaluated in several Phase III clinical trials. These studies, such as the Acliform (LAC 30) and Augment (LAC 31) trials, involved approximately 4,000 patients with moderate to severe COPD. The trials were randomized, double-blind, and parallel-group, comparing the combination therapy against monotherapy with aclidinium or formoterol, as well as against a placebo[4].

Key Findings

• Lung Function Improvement: The combination therapy demonstrated significant improvements in forced expiratory volume in 1 second (FEV1) both at 1 hour post-dose and at trough levels compared to monotherapy and placebo. For instance, in the Acliform study, the combination showed improvements in FEV1 of 299 mL and 125 mL compared to placebo and aclidinium, respectively[4].
• Symptom Relief: Patients treated with Duaklir Genuair experienced significant improvements in symptoms such as breathlessness, as measured by the Transition Dyspnoea Index (TDI) focal score. The TDI scores improved by 1.29 units in the Acliform study and 1.44 units in the Augment study, indicating better symptom control compared to placebo and monotherapy[4].
• Safety Profile: The combination therapy was well-tolerated, with a safety profile similar to that of the individual components and placebo. No significant increase in adverse events was observed[1][4].

Additional Studies

Other studies, such as the LAC-MD-27 trial, further supported the efficacy and safety of the combination. This study involved a crossover design and confirmed the bronchodilatory effects of aclidinium bromide/formoterol fumarate compared to monotherapy and placebo[3].

Mechanism of Action

Aclidinium Bromide

Aclidinium bromide is a long-acting muscarinic antagonist (LAMA) that inhibits the muscarinic M3 receptor, leading to bronchodilation. This mechanism helps in reducing airway resistance and improving lung function[4].

Formoterol Fumarate

Formoterol fumarate is a long-acting beta agonist (LABA) that stimulates β2 receptors in the bronchial smooth muscle, resulting in bronchodilation. This action complements the effect of aclidinium bromide, providing sustained relief from bronchospasm[4].

Market Analysis

Regulatory Approvals

Duaklir Genuair received marketing authorization from the European Commission in November 2014 for the maintenance treatment of COPD in adult patients. This approval is applicable in all EU member states and the European Economic Area[4].

Market Presence

The drug is marketed by AstraZeneca, with Circassia Pharmaceuticals holding the rights to market it in the United States as part of a strategic collaboration. Despite the initial plan to submit a new drug application (NDA) in the first half of 2018, the current status of the US approval is pending[4].

Competitive Landscape

The COPD treatment market is highly competitive, with other combination therapies such as tiotropium/olodaterol and fluticasone/salmeterol/vilanterol. However, Duaklir Genuair's unique combination of a LAMA and a LABA positions it favorably, especially given its demonstrated efficacy and safety profile[4].

Market Projections

Growth Potential

The global COPD treatment market is expected to grow significantly due to the increasing prevalence of COPD, particularly in aging populations and in regions with high air pollution. Duaklir Genuair, with its proven clinical benefits, is poised to capture a substantial share of this growing market[4].

Regional Expansion

As regulatory approvals expand to more regions, including potential approval in the United States, the market reach of Duaklir Genuair is expected to broaden. This expansion will likely drive increased sales and market penetration.

Patient Preference and Adherence

The twice-daily dosing regimen of Duaklir Genuair, delivered via the Genuair/Pressair inhaler, is designed to improve patient adherence. The ease of use and the rapid onset of action within five minutes of administration are expected to enhance patient satisfaction and compliance, further driving market growth[4].

Key Takeaways

• Clinical Efficacy: Aclidinium bromide/formoterol fumarate has demonstrated significant improvements in lung function and symptom relief in patients with COPD.
• Safety Profile: The combination therapy has a favorable safety profile, similar to that of the individual components and placebo.
• Market Approval: Duaklir Genuair has received marketing authorization in the EU and is pending approval in the US.
• Growth Potential: The drug is expected to capture a substantial share of the growing COPD treatment market due to its clinical benefits and expanding regulatory approvals.

FAQs

What is the mechanism of action of aclidinium bromide and formoterol fumarate?

Aclidinium bromide is a LAMA that inhibits the muscarinic M3 receptor, while formoterol fumarate is a LABA that stimulates β2 receptors, both leading to bronchodilation[4].

What are the key findings from the Phase III clinical trials of Duaklir Genuair?

The trials showed significant improvements in FEV1 and TDI scores, indicating better lung function and symptom control compared to monotherapy and placebo[4].

Is Duaklir Genuair approved in the United States?

As of the current date, Duaklir Genuair is not yet approved in the United States, although it has received marketing authorization in the EU[4].

How does the dosing regimen of Duaklir Genuair impact patient adherence?

The twice-daily dosing regimen, delivered via an easy-to-use inhaler, is designed to improve patient adherence by providing rapid onset of action and sustained symptom relief[4].

What is the expected market growth for Duaklir Genuair?

The drug is expected to capture a significant share of the growing COPD treatment market due to its clinical benefits and expanding regulatory approvals[4].

Sources

1. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combination in patients with COPD. PubMed.
2. Multi-Discipline Review - Duaklir Pressair. FDA.
3. Efficacy and safety study of two fixed-dose combinations of aclidinium bromide with formoterol fumarate. AstraZeneca Clinical Trials.
4. Duaklir Genuair for the Treatment of Chronic Obstructive Pulmonary Disease. Clinical Trials Arena.
5. Comparison of aclidinium bromide and formoterol fumarate in stable, moderate to severe COPD patients. AstraZeneca Clinical Trials.