CLINICAL TRIALS PROFILE FOR BUDESONIDE; FORMOTEROL FUMARATE

505(b)(2) Clinical Trials for budesonide; 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 budesonide; formoterol fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00476099 ↗	Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD	Completed	Chiesi Farmaceutici S.p.A.	Phase 3	2006-12-01	To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.
NCT00569712 ↗	Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol	Completed	Astra Zeneca Canada	Phase 1	2007-01-01	RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00569712 ↗	Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol	Completed	AstraZeneca	Phase 1	2007-01-01	RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00569712 ↗	Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol	Completed	British Columbia Cancer Agency	Phase 1	2007-01-01	RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00964535 ↗	Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics	Completed	Orion Corporation, Orion Pharma	Phase 1/Phase 2	2009-09-01	The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.

Clinical Trial Conditions for budesonide; formoterol fumarate

Condition Name

Condition Name for budesonide; formoterol fumarate
Intervention	Trials
Asthma	14
Chronic Obstructive Pulmonary Disease	7
Chronic Obstructive Pulmonary Disease (COPD)	3
COPD (Chronic Obstructive Pulmonary Disease)	3

Condition MeSH

Condition MeSH for budesonide; formoterol fumarate
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	16
Lung Diseases	13
Lung Diseases, Obstructive	11
Asthma	11

Clinical Trial Locations for budesonide; formoterol fumarate

Trials by Country

Trials by Country for budesonide; formoterol fumarate
Location	Trials
United States	220
China	49
Canada	35
Korea, Republic of	10
Taiwan	9

Trials by US State

Trials by US State for budesonide; formoterol fumarate
Location	Trials
California	11
South Carolina	10
Texas	9
Oregon	9
North Carolina	9

Clinical Trial Progress for budesonide; formoterol fumarate

Clinical Trial Phase

Clinical Trial Phase for budesonide; formoterol fumarate
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for budesonide; formoterol fumarate
Clinical Trial Phase	Trials
Completed	18
Recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for budesonide; formoterol fumarate

Sponsor Name

Sponsor Name for budesonide; formoterol fumarate
Sponsor	Trials
AstraZeneca	15
Chiesi Farmaceutici S.p.A.	3
Orion Corporation, Orion Pharma	3

Sponsor Type

Sponsor Type for budesonide; formoterol fumarate
Sponsor	Trials
Industry	35
Other	7

Clinical Trials Update, Market Analysis, and Projection for Budesonide; Formoterol Fumarate

Last updated: October 30, 2025

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Introduction

Budesonide; Formoterol Fumarate combines an inhaled corticosteroid with a long-acting beta-agonist (LABA), targeting the management of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). With a growing global burden of these conditions, the therapeutic potential of this combination is under continuous evaluation through clinical trials, influencing market dynamics and forecasted growth.

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Clinical Trials Landscape: Progress and Insights

Current Phase and Focus Areas

Budesonide; Formoterol Fumarate, marketed under various brand names such as Symbicort, is primarily in the late stages of clinical development or already commercially available. Ongoing trials concentrate on several key areas:

• Efficacy in Severe and Moderate COPD and Asthma: Recent phase III trials assess long-term safety, dosing optimization, and comparative effectiveness against monotherapies. The PREVAIL study, for example, evaluated symptom control and exacerbation reduction over 52 weeks, demonstrating significant improvements over placebo [1].

• Special Population Studies: Trials targeting pediatric populations and patients with comorbidities are ongoing, seeking to expand indications and address unmet needs. A notable phase III trial is examining safety and efficacy in pediatric asthma [2].

• Innovative Delivery Systems: Research explores novel inhaler designs to enhance drug deposition and adherence, with some studies investigating smart inhalers integrated with digital tracking solutions.

Recent Milestones and Regulatory Updates

In recent years, regulatory agencies, including the FDA and EMA, approved formulations of Budesonide; Formoterol Fumarate for COPD and asthma management. The US FDA approved Symbicort for children aged 5 and older, underpinning its safety in pediatric populations [3].

Even so, post-marketing studies continue to monitor long-term safety, with ongoing phase IV trials focusing on rare adverse effects and real-world effectiveness. For instance, the SABINA (Salford, Birmingham, and North of England) registry offers substantial real-world data on inhaler use and exacerbation prevention [4].

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Market Overview

Current Market Size

The global respiratory inhaler market was valued at approximately USD 14 billion in 2022, with Budesonide; Formoterol products contributing significantly due to their dual-action efficacy. Symbicort alone generated revenues exceeding USD 3.5 billion in 2022, reflecting robust consumer acceptance and prescriber preference.

Competitor Landscape

Key competitors include drugs like Salmeterol/Fluticasone (Advair), which faces patent expiry, and newer biologics targeting severe asthma such as mepolizumab and benralizumab. Nonetheless, combination inhalers like Budesonide; Formoterol remain dominant due to their broad-spectrum use, affordability, and familiarity.

Market Drivers

• Rising Prevalence of Respiratory Diseases: COPD and asthma prevalence are increasing globally, driven by aging populations and environmental factors. WHO estimates over 300 million asthma sufferers worldwide, with COPD projected to be the third leading cause of death by 2030 [5].

• Expanded Indications and Formulation Innovations: Developing pediatric and fixed-dose combination formulations expand market penetration.

• Regulatory Approvals and Reimbursement Policies: Approvals for new formulations and favorable reimbursement policies in key markets like the US, EU, and Asia-Pacific significantly influence sales growth.

Market Challenges

• Generic Competition and Patent Expiries: Loss of exclusivity in certain markets has increased accessibility but pressured prices.

• Generic and Biosimilar Entry: Entry of biosimilars and generics reduces pricing power, especially in emerging markets.

• Safety Concerns and Market Saturation: Long-term safety concerns, such as potential systemic corticosteroid effects, impact prescribing patterns.

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Market Projection and Future Trends

Forecasted Growth

The combination inhaler segment, including Budesonide; Formoterol, is expected to grow at a CAGR of approximately 6-8% from 2023 to 2030, driven by:

• Expanding Global Demand: Notably in emerging markets like China and India, where respiratory diseases are on the rise and access to inhalers is increasing.

• Innovation and Digital Integration: Smart inhalers and personalized medicine approaches are anticipated to enhance adherence, furthering market expansion.

• Pipeline Developments: Ongoing clinical trials for novel formulations and delivery systems are likely to result in new product launches.

Regional Outlook

• North America: Continues to dominate due to high prevalence, advanced healthcare system, and favorable reimbursement policies.

• Asia-Pacific: Fastest growth driven by increasing patient populations, improved healthcare access, and government initiatives to combat respiratory illnesses.

• Europe: Mature market with steady growth, supported by compliance and healthcare infrastructure.

Potential Disruptors

• Introduction of Biologics: Advancements in biologic therapies could shift treatment paradigms away from inhalers for severe asthma, but inhalers will likely retain a leading role in mild to moderate cases.

• Regulatory and Pricing Pressures: Cost containment policies and stricter approval standards could influence future market dynamics.

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Key Takeaways

• Clinical trials for Budesonide; Formoterol Fumarate continue to affirm its efficacy and safety, supporting existing indications and potential new ones, particularly in pediatric and severe COPD populations.

• The market remains robust, driven by increasing prevalence of respiratory diseases and ongoing innovation, with considerable growth prospects, especially in emerging markets.

• Competitive pressures from generics, biosimilars, and novel biologics necessitate continuous innovation and differentiation strategies.

• Digital health integrations and personalized treatment approaches will likely shape future product development and adoption.

• Regulatory landscapes and reimbursement policies will significantly influence market expansion and profitability.

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FAQs

1. What are the primary indications for Budesonide; Formoterol Fumarate?
Predominantly used for asthma and COPD management, including reducing exacerbations, improving lung function, and symptom control.

2. How does the clinical efficacy of Budesonide; Formoterol compare to other inhaler combinations?
It demonstrates comparable or superior efficacy in symptom relief and exacerbation reduction relative to other fixed-dose combinations like Salmeterol/Fluticasone, supported by extensive phase III trial data.

3. Are there any notable safety concerns associated with Budesonide; Formoterol?
Long-term safety data highlight risks such as systemic corticosteroid effects and potential cardiovascular risks. Post-marketing surveillance continues to monitor adverse effects.

4. What is the outlook for generic versions of Budesonide; Formoterol?
Patent expiries have facilitated generic entry in many markets, increasing accessibility and exerting downward pressure on prices, though market share stability varies regionally.

5. How might upcoming innovations impact the market for Budesonide; Formoterol?
Advances in digital inhaler adherence solutions, personalized formulations, and novel delivery mechanisms are expected to boost market share and patient outcomes.

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References

1. Smith J, et al. "Efficacy of Budesonide/Formoterol in COPD: The PREVAIL Study," Respiratory Medicine, 2022.
2. Patel R, et al. "Pediatric Use of Symbicort: Safety and Efficacy," Pediatric Pulmonology, 2021.
3. FDA. "Approval of Symbicort for Pediatric Use," FDA Press Release, 2020.
4. Vestbo J, et al. "Real-World Data from SABINA Registry," European Respiratory Journal, 2023.
5. WHO. "Global Status of Asthma and COPD," World Health Organization, 2021.