CLINICAL TRIALS PROFILE FOR FORMOTEROL FUMARATE

505(b)(2) Clinical Trials for FORMOTEROL FUMARATE

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 Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for FORMOTEROL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139932 ↗	Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272)	Completed	Integrated Therapeutics Group	Phase 4	2005-09-01	This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00139932 ↗	Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272)	Completed	Novartis	Phase 4	2005-09-01	This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00139932 ↗	Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2005-09-01	This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00215358 ↗	Study in Patients With Asthma	Completed	Dey	Phase 2	2002-07-01	The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control drug.
NCT00215371 ↗	Study in Patients With Asthma	Completed	Dey	Phase 2	2002-07-01	The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.
NCT00215384 ↗	Study in Patients With COPD	Completed	Dey	Phase 2	1969-12-31	The purpose of this study is to determine which dose of the investigational drug is the most safe and effective compared to the control drug.

Clinical Trial Conditions for FORMOTEROL FUMARATE

Condition Name

Condition Name for FORMOTEROL FUMARATE
Intervention	Trials
Asthma	55
Chronic Obstructive Pulmonary Disease	32
COPD	17
Chronic Obstructive Pulmonary Disease (COPD)	14

Condition MeSH

Condition MeSH for FORMOTEROL FUMARATE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	67
Lung Diseases	56
Lung Diseases, Obstructive	55
Asthma	53

Clinical Trial Locations for FORMOTEROL FUMARATE

Trials by Country

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Trials by Country for FORMOTEROL FUMARATE
Location	Trials
United States	849
Canada	62
China	53
Hungary	29
Germany	28

Trials by US State

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Trials by US State for FORMOTEROL FUMARATE
Location	Trials
California	43
Oregon	41
South Carolina	40
Florida	39
Texas	36

Clinical Trial Progress for FORMOTEROL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for FORMOTEROL FUMARATE
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	64
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for FORMOTEROL FUMARATE
Clinical Trial Phase	Trials
Completed	107
Recruiting	11
Not yet recruiting	10

Clinical Trial Sponsors for FORMOTEROL FUMARATE

Sponsor Name

Sponsor Name for FORMOTEROL FUMARATE
Sponsor	Trials
Chiesi Farmaceutici S.p.A.	35
AstraZeneca	30
Dey	18

Sponsor Type

Sponsor Type for FORMOTEROL FUMARATE
Sponsor	Trials
Industry	151
Other	35

Formoterol Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction

Formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), is a crucial medication in the management of chronic obstructive pulmonary disease (COPD) and asthma. This article delves into the current clinical trials, market analysis, and future projections for formoterol fumarate, highlighting its significance in respiratory care.

Clinical Trials Update

AstraZeneca's THARROS Trial

AstraZeneca has initiated the Phase III THARROS trial to evaluate the efficacy of Breztri (budesonide / glycopyrronium / formoterol fumarate) in reducing severe cardiopulmonary outcomes in patients with COPD. This trial, enrolling 5,000 patients, uses a novel composite endpoint that includes the time to first severe cardiac event, severe COPD exacerbation, or cardiopulmonary death. This study aims to demonstrate the potential of triple therapy in addressing cardiopulmonary risk in COPD patients[1].

ATHLOS Trial

In addition to the THARROS trial, AstraZeneca is conducting the Phase III ATHLOS trial, which assesses the effect of Breztri on exercise parameters in COPD patients compared to a dual therapy of budesonide / formoterol fumarate. This trial is expected to enroll 180 patients and has a primary completion date of August 2025[1].

Safety and Efficacy Studies

Previous studies have shown that formoterol fumarate does not increase the risk of asthma-related deaths compared to non-LABA treatments. A comprehensive analysis of 149 trials involving 104,463 patients indicated no increased risk of asthma-related deaths and a significant reduction in nonfatal asthma-related serious adverse events[4].

Market Analysis

Market Size and Growth

The global formoterol fumarate market is a multi-billion-dollar industry, driven primarily by the increasing prevalence of respiratory diseases such as asthma and COPD. The market is segmented by product type, dosage form, distribution channel, and geography, catering to diverse patient needs[3].

Market Drivers

• Rising Prevalence of Respiratory Diseases: The growing incidence of asthma and COPD, exacerbated by factors like air pollution, smoking, and aging, has fueled the demand for effective maintenance and relief treatments.
• Technological Advancements: Innovations in inhalation devices and combination products have enhanced efficacy, safety, and patient convenience.
• Growing Awareness: Increased awareness among healthcare professionals and patients about the role of formoterol fumarate in improving lung function and reducing exacerbations has driven market expansion[3].

Market Restraints

• Regulatory Requirements: Stringent safety, efficacy, and quality regulations pose challenges for market growth.
• High R&D Costs: The high costs associated with research and development can limit wider adoption.
• Patient Compliance Issues: Ensuring patient adherence to formoterol fumarate inhalation solutions remains a significant challenge[2].

Market Projections

Future Growth

The formoterol fumarate market is expected to continue its growth trajectory, driven by the increasing prevalence of respiratory diseases and advancements in inhalation technology. The Asia-Pacific region is anticipated to witness the fastest growth due to expanding patient populations and improving healthcare systems[3].

Emerging Opportunities

• Innovative Formulations: Developing novel inhalation devices and combination products can enhance drug delivery, improve safety, and promote patient adherence.
• Digital Integration: The integration of digital technologies, such as connected inhalers and mobile applications, can enhance the patient experience and provide valuable data for treatment optimization.
• Expanding Healthcare Infrastructure: Increasing access to specialized respiratory care in emerging markets presents substantial opportunities for market growth[3].

Competitive Landscape

Key Players

The market is characterized by the presence of both well-established pharmaceutical companies and specialized manufacturers. AstraZeneca, with its Breztri formulation, is a key player in this market. Other companies are also focusing on developing innovative and user-friendly formoterol fumarate preparations[3].

Porter’s Five Forces Analysis

This analysis highlights the competitive position and power dynamics in the formoterol fumarate market. It helps businesses understand their strengths, weaknesses, and potential opportunities and threats, enabling them to make informed strategic decisions[2].

Patient Demographics and Needs

Aging Population

The aging population is particularly prone to respiratory diseases, creating a significant demand for effective maintenance and relief treatments like formoterol fumarate. Tailoring products to meet the specific needs of this demographic can drive market growth[2].

Patient Compliance

Ensuring patient compliance is crucial. Strategies such as creating patient testimonial videos, developing training modules for healthcare providers, and leveraging telemedicine can improve adherence and trust in formoterol fumarate inhalation solutions[2].

Conclusion

Formoterol fumarate remains a vital component in the management of COPD and asthma, with ongoing clinical trials and market growth driven by increasing prevalence and technological advancements. As the market continues to evolve, focusing on innovative formulations, digital integration, and patient compliance will be key to addressing the unmet needs in respiratory care.

Key Takeaways

• Clinical Trials: Ongoing Phase III trials like THARROS and ATHLOS are evaluating the efficacy of formoterol fumarate in COPD patients.
• Market Growth: The market is driven by the rising prevalence of respiratory diseases and technological advancements.
• Regulatory Challenges: Stringent regulatory requirements and high R&D costs are significant challenges.
• Patient Compliance: Ensuring patient adherence is crucial for market success.
• Future Opportunities: Innovations in inhalation devices, digital integration, and expanding healthcare infrastructure in emerging markets offer substantial growth opportunities.

FAQs

Q: What is the primary use of formoterol fumarate in respiratory care?

A: Formoterol fumarate is primarily used as a bronchodilator to manage chronic obstructive pulmonary disease (COPD) and asthma by relaxing muscles in the airways and improving breathing.

Q: What are the key clinical trials currently underway for formoterol fumarate?

A: AstraZeneca's THARROS and ATHLOS trials are significant ongoing studies evaluating the efficacy of formoterol fumarate in reducing severe cardiopulmonary outcomes and improving exercise parameters in COPD patients.

Q: What are the main drivers of the formoterol fumarate market?

A: The market is driven by the increasing prevalence of respiratory diseases, technological advancements in inhalation devices, and growing awareness among healthcare professionals and patients.

Q: What are the major challenges facing the formoterol fumarate market?

A: The market faces challenges such as stringent regulatory requirements, high costs of research and development, and patient compliance issues.

Q: How is the formoterol fumarate market expected to grow in the future?

A: The market is expected to continue growing, driven by the increasing prevalence of respiratory diseases, advancements in inhalation technology, and the expansion of healthcare infrastructure in emerging markets.

Sources

1. AstraZeneca kick-starts Phase III COPD trial for Breztri. Clinical Trials Arena.
2. Formoterol Fumarate Inhalation Solution Market 2025-2030. 360iResearch.
3. Formoterol Fumarate Preparations Market Size, Share, Growth. DataHorizon Research.
4. Safety of formoterol in asthma clinical trials: an update. PubMed.
5. A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler. AstraZeneca Clinical Trials.