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.
NCT01186653 ↗	Effect on Adrenal Function of Budesonide Versus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)	Completed	Hull and East Yorkshire Hospitals NHS Trust	Phase 4	2007-10-01	National Institute for Clinical Excellence (NICE) guidelines recommend high dose inhaled steroids for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD, a common chronic disease related to smoking) who are having two or more exacerbations requiring treatment with antibiotics or oral steroids in a 12 month period. The preparations licensed for this indication commercially available are Symbicort® and Seretide®. High dose inhaled steroids (contained in both) can cause suppression of the adrenal glands. The investigators want to assess adrenal suppression caused by the two preparations and compare. The results could guide investigators in prescribing these preparations.
NCT01186653 ↗	Effect on Adrenal Function of Budesonide Versus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)	Completed	Hull University Teaching Hospitals NHS Trust	Phase 4	2007-10-01	National Institute for Clinical Excellence (NICE) guidelines recommend high dose inhaled steroids for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD, a common chronic disease related to smoking) who are having two or more exacerbations requiring treatment with antibiotics or oral steroids in a 12 month period. The preparations licensed for this indication commercially available are Symbicort® and Seretide®. High dose inhaled steroids (contained in both) can cause suppression of the adrenal glands. The investigators want to assess adrenal suppression caused by the two preparations and compare. The results could guide investigators in prescribing these preparations.

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	52
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
Oregon	9
North Carolina	9
Missouri	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	8

Budesonide / Formoterol Fumarate: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 29, 2026

What is the current clinical-trials landscape for budesonide / formoterol fumarate?

Budesonide plus formoterol fumarate is marketed as an inhaled corticosteroid (ICS) and long-acting beta2 agonist (LABA) combination. Public clinical-trials activity is dominated by (1) head-to-head and inhalation-device studies, (2) safety/tolerability and real-world evidence generation, and (3) subpopulation assessments (elderly, asthma control strata, smoking history, and comorbidity-linked outcomes). Trial volumes typically concentrate in asthma and COPD labeling-adjacent populations, with endpoints centered on lung function (FEV1/PEF), exacerbation rates, symptom control, and rescue medication use.

Key clinical-trials patterns observed in the public domain

• Device and formulation comparisons: inhaler delivery performance and patient handling (dose consistency, inhalation technique sensitivity, residency time in airways).
• Asthma control maintenance: primary or co-primary outcomes tied to symptom-free days and exacerbations.
• COPD exacerbation reduction: FEV1 and exacerbation endpoints, with common inclusion of patients already on background bronchodilators.
• Safety monitoring: composite adverse event rates, growth effects in pediatric asthma where applicable, and cardiovascular/psychiatric safety surveillance typical of LABA class programs.

Because budesonide/formoterol is mature and widely marketed, many ongoing studies tend to be incremental rather than disruptive, with the main competitive battleground shifting to device performance, adherence, and guideline-aligned dosing regimens rather than novel pharmacology.

What clinical evidence matters most for competitive positioning?

Clinical programs for ICS/LABA combinations typically translate into payer and guideline access via three measurable value drivers:

1. Exacerbation reduction durability
   • Demonstrated reduction in asthma exacerbations and COPD exacerbations versus monotherapy or non-ICS controls is the core evidence pattern shaping reimbursement and formulary placement.
2. Lung function and symptom control
   • FEV1 and rescue medication reduction remain the most widely repeated quantitative endpoints in post-launch studies.
3. Safety profile and tolerability
   • ICS systemic risk management (oral candidiasis, dysphonia, rare adrenal suppression at higher doses) and LABA class monitoring (tachyarrhythmia-related events, tremor, and cardiovascular risk signals) define label comfort for formulary committees.

What is the market structure and competitive field?

Where does budesonide / formoterol fumarate sit in the inhaled-therapy stack?

Budesonide / formoterol fumarate sits in the ICS/LABA segment where it competes against:

• Other ICS/LABA combinations (budesonide-formoterol alternatives and fluticasone-based regimens).
• Triple therapies in COPD (ICS/LABA/LAMA) where guideline pathways increasingly favor escalation for exacerbation-prone patients.
• ICS/LABA in asthma where step-up often remains within ICS/LABA until switching to MART (maintenance and reliever therapy) approaches or escalation.

Competitive implications

• Pricing power is constrained by generic entry risk and large-label competition.
• Differentiation is primarily device and regimen (including dosing cadence, patient usability, and MART-style use where labels support it).
• Real-world adherence has become a major determinant of outcomes, shifting competitive advantage toward inhalers with higher technique robustness.

How do pricing, access, and reimbursement dynamics shape the outlook?

ICS/LABA inhalers are usually evaluated on:

• Exacerbation and healthcare utilization (cost offsets).
• Formulary tier placement (preferred vs non-preferred).
• Switchability (therapeutic interchange rules between ICS/LABA products).
• Indexing to guideline updates (asthma action plans and COPD escalation frameworks).

In practice, mature ICS/LABA brands often face:

• Downward pricing pressure from generics.
• Margin compression due to pharmacy benefit manager formularies and rebates.
• Constrained growth in developed markets, with stronger relative growth in markets with expanding diagnosed prevalence and healthcare access.

What does the future market projection look like?

A precise projection requires country-level demand, pricing, and competitive entry timing. Publicly available patent and market datasets can support directionally correct forecasts, but translating that into a single quantified global projection for budesonide/formoterol specifically requires inputs beyond what is provided here.

Under the constraints of this request, the most defensible projection framework is a scenario-based directional forecast built on class dynamics:

Base-case direction (directional)

• Mature market, low-to-mid single-digit growth in unit demand globally, driven by:
  • COPD/asthma prevalence trends and diagnosis rates.
  • Continued guideline adherence for ICS/LABA as step therapy.
• Value growth lags units due to competitive pressure and discounting, especially in markets with generic penetration.

Upside/downside drivers

• Upside
  • Improved device usability and adherence leading to higher persistence.
  • Local market expansions and managed-care formularies favoring ICS/LABA combinations.
• Downside
  • Rapid uptake of COPD triple therapy in exacerbation-prone cohorts.
  • Switch-to-generic across multiple markets compressing branded revenue.

What is the patent and exclusivity relevance for near-term strategy?

For budesonide/formoterol, the strategic patent posture is generally:

• Limited incremental exclusivity for fully mature combinations.
• Potential value in device patents and formulation improvements, with the main lever being new product life-cycle management rather than broad method-of-treatment patents.

From a business perspective, the near-term market defense typically relies on:

• Device differentiation,
• Contracting and payer access,
• Patient support programs tied to inhaler technique,
• Range expansion via line extensions (dose strengths, delivery mechanism, and regimen simplification) where allowed.

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Key Takeaways

• Budesonide/formoterol clinical activity in the public domain is concentrated in incremental post-launch evidence: device handling, regimen optimization, and subpopulation safety and effectiveness.
• Competitive positioning is increasingly determined by adherence and inhaler usability rather than pharmacology innovation, since the core drug combination is mature.
• Market trajectory is units supported, value pressured, with COPD triple therapy taking share in higher exacerbation-risk segments.
• Strategic focus for stakeholders typically centers on payer access, patient persistence, and lifecycle management.

FAQs

1) Are budesonide/formoterol trials still primarily asthma-focused?

Yes. Public trial activity centers on asthma control and exacerbation endpoints, with COPD studies typically aligned to guideline-adjacent use.

2) What endpoints dominate for ICS/LABA combination studies?

FEV1 or lung function metrics, exacerbation rates, symptom control, and rescue medication use are the most repeated quantitative endpoints. Safety monitoring is continuous due to class-relevant adverse events.

3) How does triple therapy affect budesonide/formoterol market growth in COPD?

Triple therapy is the main share-takeover route for exacerbation-prone COPD, shifting ICS/LABA toward earlier lines or less severe segments depending on local guideline adoption.

4) What is the most important differentiator for this product class post-generic entry?

Inhaler device performance and regimen usability drive persistence and real-world outcomes, which translate into payer and guideline preference.

5) What does the near-term commercial strategy typically prioritize?

Formulary contracting, reduced total cost of care via exacerbation prevention, and adherence programs tied to inhalation technique.

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References

[1] U.S. Food and Drug Administration. (n.d.). Drug Trials Snapshots for budesonide/formoterol products (where available). FDA.
[2] European Medicines Agency. (n.d.). EPARs and product information for budesonide/formoterol-containing inhalation products. EMA.
[3] ClinicalTrials.gov. (n.d.). Search results for budesonide formoterol fumarate (trial listings and statuses). U.S. National Library of Medicine.
[4] Global Initiative for Asthma (GINA). (latest edition year available). Global Strategy for Asthma Management and Prevention. GINA.
[5] Global Initiative for Chronic Obstructive Lung Disease (GOLD). (latest edition year available). Global Strategy for Prevention, Diagnosis and Treatment of COPD. GOLD.