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.

Clinical Trial Conditions for BUDESONIDE; FORMOTEROL FUMARATE

Condition Name

Condition Name for BUDESONIDE; FORMOTEROL FUMARATE
Intervention	Trials
Asthma	14
Chronic Obstructive Pulmonary Disease	6
Chronic Obstructive Pulmonary Disease (COPD)	3

Condition MeSH

Condition MeSH for BUDESONIDE; FORMOTEROL FUMARATE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	14
Lung Diseases	13
Asthma	11

Clinical Trial Locations for BUDESONIDE; FORMOTEROL FUMARATE

Trials by Country

Trials by Country for BUDESONIDE; FORMOTEROL FUMARATE
Location	Trials
United States	181
China	48
Canada	28
Korea, Republic of	10
Taiwan	8

Trials by US State

Trials by US State for BUDESONIDE; FORMOTEROL FUMARATE
Location	Trials
California	10
South Carolina	9
Oregon	8
North Carolina	8
Missouri	8

Clinical Trial Progress for BUDESONIDE; FORMOTEROL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for BUDESONIDE; FORMOTEROL FUMARATE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	15
Phase 2	1

Clinical Trial Status

Clinical Trial Status for BUDESONIDE; FORMOTEROL FUMARATE
Clinical Trial Phase	Trials
Completed	18
Recruiting	6
Not yet recruiting	4

Clinical Trial Sponsors for BUDESONIDE; FORMOTEROL FUMARATE

Sponsor Name

Sponsor Name for BUDESONIDE; FORMOTEROL FUMARATE
Sponsor	Trials
AstraZeneca	12
Orion Corporation, Orion Pharma	3
Chiesi Farmaceutici S.p.A.	3

Sponsor Type

Sponsor Type for BUDESONIDE; FORMOTEROL FUMARATE
Sponsor	Trials
Industry	31
Other	7

BUDESONIDE; FORMOTEROL FUMARATE Market Analysis and Financial Projection

Budesonide and Formoterol Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction

Budesonide and Formoterol Fumarate, a combination of an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA), is a widely used treatment for asthma and chronic obstructive pulmonary disease (COPD). This article will delve into recent clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Asthma Studies

Several clinical trials have evaluated the efficacy and safety of Budesonide and Formoterol Fumarate in patients with asthma.

• 12-Week Efficacy and Safety Study: A double-blind, placebo-controlled study compared SYMBICORT (Budesonide/Formoterol Fumarate) with budesonide alone, formoterol alone, the free combination of budesonide and formoterol, and placebo. The study showed sustained improvement in lung function and reduced asthma symptoms in patients receiving SYMBICORT compared to the other treatments[2].

• 52-Week Phase III Study: This study evaluated the efficacy and safety of SYMBICORT Turbuhaler® compared to terbutaline Turbuhaler® and Pulmicort® (budesonide) Turbuhaler® plus terbutaline. The results indicated that SYMBICORT provided better control of asthma symptoms and improved lung function over the 52-week period[3].

• 24-Week Efficacy and Safety Study: A randomized, double-blind, parallel-group study assessed the efficacy and safety of Budesonide and Formoterol Fumarate metered dose inhaler (MDI) relative to Budesonide MDI and open-label Symbicort® Turbuhaler® in participants with inadequately controlled asthma. The study found that the combination therapy was more effective in improving lung function and reducing asthma exacerbations compared to budesonide alone[4].

COPD Studies

For COPD, a recent clinical trial is noteworthy:

• ATHLOS Study: This Phase 3, double-blind, multicentre, randomized, three-period, three-treatment, cross-over study evaluated the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) MDI compared with Budesonide and Formoterol Fumarate (BFF) MDI and placebo MDI on exercise parameters in participants with COPD. The study aims to assess the impact of these combinations on exercise tolerance and lung function in COPD patients[1].

Efficacy and Safety Outcomes

Lung Function Improvement

Clinical trials consistently show that the combination of Budesonide and Formoterol Fumarate improves lung function in both asthma and COPD patients. For example, in the 12-week asthma study, SYMBICORT demonstrated significant improvements in predose FEV1 (forced expiratory volume in one second) and 12-hour average postdose FEV1 compared to other treatments[2].

Symptom Control and Exacerbations

The combination therapy has also been shown to reduce asthma symptoms and exacerbations. In the 52-week study, SYMBICORT Turbuhaler® resulted in better control of asthma symptoms and fewer exacerbations compared to terbutaline and budesonide alone[3].

Safety Profile

The safety profile of Budesonide and Formoterol Fumarate has been generally favorable, with common side effects including oral thrush, cough, and headache. However, as with any ICS/LABA combination, there is a risk of serious side effects such as pneumonia and increased cardiovascular events, which are closely monitored in clinical trials[2][4].

Market Analysis

Current Market Position

Budesonide and Formoterol Fumarate, marketed under brands like SYMBICORT, is a leading treatment in the respiratory market. It is widely prescribed for both asthma and COPD due to its proven efficacy and safety profile.

Market Trends

The respiratory drug market is growing, driven by increasing prevalence of respiratory diseases and advancements in treatment options. The ICS/LABA combination segment is particularly strong, with Budesonide and Formoterol Fumarate being one of the key players.

Cost-Effectiveness

A budget impact analysis in mild asthma patients showed that using Budesonide/Formoterol Fumarate instead of salbutamol results in better patient outcomes and reduces total healthcare costs, despite higher drug costs. This is due to reduced exacerbations and lower non-drug costs such as hospitalizations and lost productivity[5].

Market Projections

Growth Potential

The market for Budesonide and Formoterol Fumarate is expected to grow due to several factors:

• Increasing prevalence of asthma and COPD.
• Expanding indications and approvals for new patient populations.
• Continued preference for combination therapies over monotherapies due to their superior efficacy.

Competitive Landscape

The respiratory market is competitive, with other ICS/LABA combinations such as fluticasone/salmeterol and beclomethasone/formoterol. However, Budesonide and Formoterol Fumarate remains a strong contender due to its established brand and extensive clinical evidence.

Emerging Markets

Emerging markets, particularly in Asia and Latin America, offer significant growth opportunities. As healthcare infrastructure improves and access to medications increases, the demand for effective respiratory treatments like Budesonide and Formoterol Fumarate is expected to rise.

Key Takeaways

• Clinical Efficacy: Budesonide and Formoterol Fumarate has demonstrated significant improvements in lung function and symptom control in both asthma and COPD patients.
• Safety Profile: The combination has a generally favorable safety profile, although it carries risks associated with ICS/LABA therapy.
• Market Position: It is a leading treatment in the respiratory market, with a strong brand presence.
• Cost-Effectiveness: It offers better patient outcomes and reduced total healthcare costs despite higher drug costs.
• Growth Potential: The market is expected to grow driven by increasing disease prevalence, expanding indications, and preference for combination therapies.

FAQs

Q: What are the primary components of the Budesonide and Formoterol Fumarate combination?

A: The primary components are Budesonide, an inhaled corticosteroid (ICS), and Formoterol Fumarate, a long-acting beta-agonist (LABA).

Q: What are the common indications for Budesonide and Formoterol Fumarate?

A: It is commonly used to treat asthma and chronic obstructive pulmonary disease (COPD).

Q: What are the key findings from recent clinical trials?

A: Recent trials have shown improved lung function, reduced asthma symptoms, and fewer exacerbations compared to monotherapies or placebo.

Q: How does the cost-effectiveness of Budesonide and Formoterol Fumarate compare to other treatments?

A: It offers better patient outcomes and reduces total healthcare costs, despite higher drug costs, by reducing exacerbations and non-drug costs.

Q: What are the potential side effects of Budesonide and Formoterol Fumarate?

A: Common side effects include oral thrush, cough, and headache. Serious side effects can include pneumonia and increased cardiovascular events.

Sources

1. AstraZeneca Clinical Trials: A Study to Evaluate the Effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI) Compared with Placebo MDI.
2. Symbicort Touchpoints: Asthma Clinical Trial Data for SYMBICORT® (budesonide/formoterol).
3. ClinicalTrials.gov: Study Protocol - ClinicalTrials.gov.
4. AstraZeneca Clinical Trials: A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler.
5. PubMed: A budget impact analysis of budesonide/formoterol in patients with mild asthma.