CLINICAL TRIALS PROFILE FOR BUDESONIDE

505(b)(2) Clinical Trials for Budesonide

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 Formulation	NCT00641979 ↗	New Nasal Applicator / New Formulation - User Study	Completed	AstraZeneca	Phase 2	2002-04-01	The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	CAMP Steering Committee	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	Johns Hopkins Bloomberg School of Public Health	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00004842 ↗	Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis	Completed	Mayo Clinic	Phase 1	1997-05-01	OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.
NCT00004842 ↗	Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1	1997-05-01	OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.

Clinical Trial Conditions for Budesonide

Condition Name

Condition Name for Budesonide
Intervention	Trials
Asthma	147
Chronic Obstructive Pulmonary Disease	24
Eosinophilic Esophagitis	15
Chronic Obstructive Pulmonary Disease (COPD)	11

Condition MeSH

Condition MeSH for Budesonide
Intervention	Trials
Asthma	151
Pulmonary Disease, Chronic Obstructive	56
Lung Diseases	55
Lung Diseases, Obstructive	50

Clinical Trial Locations for Budesonide

Trials by Country

Trials by Country for Budesonide
Location	Trials
United States	912
Canada	115
China	114
Germany	75
United Kingdom	46

Trials by US State

Trials by US State for Budesonide
Location	Trials
California	57
North Carolina	41
Texas	40
Florida	38
Pennsylvania	36

Clinical Trial Progress for Budesonide

Clinical Trial Phase

Clinical Trial Phase for Budesonide
Clinical Trial Phase	Trials
Phase 4	104
Phase 3	136
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for Budesonide
Clinical Trial Phase	Trials
Completed	276
Recruiting	41
Unknown status	36

Clinical Trial Sponsors for Budesonide

Sponsor Name

Sponsor Name for Budesonide
Sponsor	Trials
AstraZeneca	103
Dr. Falk Pharma GmbH	20
GlaxoSmithKline	14

Sponsor Type

Sponsor Type for Budesonide
Sponsor	Trials
Other	345
Industry	298
NIH	20

Budesonide: Clinical Trials, Market Analysis, and Projections

Introduction to Budesonide

Budesonide is a synthetic corticosteroid widely used in the treatment of various respiratory and autoimmune conditions. Its versatility and efficacy have made it a cornerstone in managing diseases such as asthma, chronic obstructive pulmonary disease (COPD), and immunoglobulin A (IgA) nephropathy.

Clinical Trials Update

Respiratory Conditions

Several ongoing and recent clinical trials highlight the continued interest in budesonide for respiratory diseases.

• ATHLOS Study: This Phase 3, double-blind, multicentre, randomized, three-period, three-treatment, cross-over study evaluates the effect of a metered dose inhaler (MDI) containing budesonide, glycopyrronium, and formoterol fumarate (BGF) compared to budesonide and formoterol fumarate (BFF) and a placebo in participants with COPD. The study focuses on exercise parameters and is conducted by AstraZeneca[1].

• BATURA Study: This clinical trial, sponsored by Avillion, compares the safety and efficacy of PT027 (budesonide/albuterol MDI 80/90 μg) with PT007 (albuterol MDI 90 μg) in participants with asthma. The study aims to assess the use of these inhalers as needed for asthma management[4].

Immunoglobulin A (IgA) Nephropathy

• NefIgArd Clinical Trial: This Phase 3, placebo-controlled trial evaluated the efficacy of a delayed-release formulation of budesonide (TARPEYO/Kinpeygo) in adults with primary IgA nephropathy at risk of rapid disease progression. The results showed a significant reduction in proteinuria and a slower decline in kidney function compared to placebo. This formulation is developed by Calliditas Therapeutics AB and has been approved for commercialization in several regions[3].

Market Analysis

Global Market Segmentation

The budesonide market is segmented based on product type, application, and region.

• Product Type: Budesonide is available in various forms, including aerosols, sprays, inhalants, and oral and rectal formulations. The inhaler segment is particularly significant due to its widespread use in managing respiratory conditions[2][5].

• Application: The market is segmented into hospital, pharmacy, clinic, and other settings. The increasing demand for budesonide inhalers in households and clinics reflects its role in both acute and long-term respiratory management[2][5].

• Region: The Asia-Pacific region holds a significant market share due to the large population and increasing pollution issues, especially in countries like India and China. North America and Europe are also expected to experience significant growth[2][5].

Market Drivers

• Upsurge in Chronic Respiratory Diseases: The rising incidence of asthma and COPD, driven by factors such as urban pollution and smoking, is a major driver for the budesonide inhaler market[5].

• Geriatric Population: The increasing geriatric population affected by respiratory disorders further boosts the demand for budesonide inhalers[5].

• Advancements in Drug Delivery Technologies: Innovations in inhaler technology and the growing preference for minimally invasive treatment methods are also driving market growth[5].

Market Restraints and Challenges

• Side Effects: Despite its efficacy, budesonide can have side effects, which can act as a restraint for the market[5].

• Availability of Alternatives: The presence of alternative treatments and technical difficulties in drug delivery can pose challenges to the market[5].

Market Opportunities

• Generic Versions: The rising number of launches of generic versions of budesonide inhalers presents opportunities for market expansion[5].

• Innovation in Inhaled Therapy: Further innovations in inhaled therapy for airway diseases are expected to drive growth in the budesonide market[5].

Market Projections

Growth Forecast

The budesonide inhaler market is expected to grow at a Compound Annual Growth Rate (CAGR) of 9.11% from 2023 to 2030. The market size increased from USD 265.99 million in 2023 to USD 290.37 million in 2024 and is projected to continue this upward trend[5].

Regional Outlook

• Asia-Pacific: This region is expected to dominate the market due to the large population and increasing health concerns related to air pollution. China is anticipated to be a key market in the near future[2][5].

• North America and Europe: These regions are also expected to experience significant growth, driven by increasing awareness of respiratory health and advancements in drug delivery technologies[2][5].

• Latin America and Middle East & Africa: These regions are projected to experience stagnant growth rates during the forecast period[2].

Key Company Profiles

Several major pharmaceutical companies are involved in the budesonide market, including:

• AstraZeneca PLC
• Abbott Laboratories
• Chiesi Farmaceutici S.p.A.
• Cipla Limited
• Novartis International AG
• Pfizer Inc.
• Takeda Pharmaceutical Company Limited
• Viatris Inc.[5]

Strategic Recommendations

For success in the budesonide inhaler market, companies should focus on:

• Resource and Capability Analysis: A comprehensive review of resources and capabilities to identify opportunities for improvement and growth.
• Innovation in Drug Delivery: Investing in advancements in inhaler technology to enhance patient compliance and efficacy.
• Market Expansion: Exploring emerging markets where healthcare infrastructure is rapidly developing and there is increased investment in public health initiatives[5].

Key Takeaways

• Budesonide is a versatile corticosteroid used in treating various respiratory and autoimmune conditions.
• Ongoing clinical trials, such as the ATHLOS and BATURA studies, are evaluating its efficacy in COPD and asthma.
• The delayed-release formulation of budesonide has shown significant benefits in treating IgA nephropathy.
• The budesonide market is driven by the increasing prevalence of chronic respiratory diseases and advancements in drug delivery technologies.
• The Asia-Pacific region is expected to dominate the market, with China being a key player.
• Companies should focus on innovation, resource analysis, and market expansion for success.

FAQs

What are the primary uses of budesonide?

Budesonide is primarily used to treat respiratory conditions such as asthma and COPD, as well as autoimmune diseases like IgA nephropathy.

What is the significance of the ATHLOS study?

The ATHLOS study is a Phase 3 clinical trial evaluating the effect of a budesonide, glycopyrronium, and formoterol fumarate MDI compared to a placebo in participants with COPD, focusing on exercise parameters.

How does the delayed-release formulation of budesonide benefit patients with IgA nephropathy?

The delayed-release formulation of budesonide (TARPEYO/Kinpeygo) has shown greater efficacy in reducing proteinuria and slowing the decline in kidney function in patients with IgA nephropathy, offering a better safety profile than conventional corticosteroids[3].

What are the key drivers of the budesonide inhaler market?

The key drivers include the upsurge in chronic respiratory diseases, the growing geriatric population affected by respiratory disorders, and advancements in drug delivery technologies[5].

Which region is expected to dominate the budesonide market in the near future?

The Asia-Pacific region, particularly China, is expected to dominate the budesonide market due to its large population and increasing health concerns related to air pollution[2][5].

What are the strategic recommendations for companies in the budesonide inhaler market?

Companies should focus on resource and capability analysis, innovation in drug delivery, and market expansion into emerging markets[5].

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. Persistence Market Research: Budesonide Market: Global Industry Analysis and Forecast 2017.
3. Clarivate: Budesonide - Clarivate.
4. American Lung Association: BATURA: A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma.
5. Research and Markets: Budesonide Inhaler Market Size, Share & Forecast to 2030.