CLINICAL TRIALS PROFILE FOR BECLOMETHASONE DIPROPIONATE

505(b)(2) Clinical Trials for Beclomethasone Dipropionate

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	NCT00497237 ↗	Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma	Completed	Chiesi Farmaceutici S.p.A.	Phase 3	2007-04-01	Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan. Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs. Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.

All Clinical Trials for Beclomethasone Dipropionate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.

Clinical Trial Conditions for Beclomethasone Dipropionate

Condition Name

Condition Name for Beclomethasone Dipropionate
Intervention	Trials
Asthma	43
Chronic Obstructive Pulmonary Disease	6
Bronchial Asthma	5

Condition MeSH

Condition MeSH for Beclomethasone Dipropionate
Intervention	Trials
Asthma	51
Pulmonary Disease, Chronic Obstructive	13
Rhinitis, Allergic	13

Clinical Trial Locations for Beclomethasone Dipropionate

Trials by Country

Trials by Country for Beclomethasone Dipropionate
Location	Trials
United States	340
Hungary	18
United Kingdom	14
Italy	14
Poland	13

Trials by US State

Trials by US State for Beclomethasone Dipropionate
Location	Trials
California	19
Texas	18
New York	15
North Carolina	15
Pennsylvania	14

Clinical Trial Progress for Beclomethasone Dipropionate

Clinical Trial Phase

Clinical Trial Phase for Beclomethasone Dipropionate
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	7

Clinical Trial Status

Clinical Trial Status for Beclomethasone Dipropionate
Clinical Trial Phase	Trials
Completed	75
Terminated	7
Withdrawn	6

Clinical Trial Sponsors for Beclomethasone Dipropionate

Sponsor Name

Sponsor Name for Beclomethasone Dipropionate
Sponsor	Trials
Chiesi Farmaceutici S.p.A.	43
Teva Branded Pharmaceutical Products R&D, Inc.	17
Teva Branded Pharmaceutical Products, R&D Inc.	11

Sponsor Type

Sponsor Type for Beclomethasone Dipropionate
Sponsor	Trials
Industry	100
Other	31
NIH	8

Beclomethasone Dipropionate: Clinical Trials Update, Market Analysis, and Future Projection

Last updated: March 23, 2026

What is the current status of clinical trials for Beclomethasone Dipropionate?

Recent clinical trial activity focuses on formulations and delivery methods for asthma and allergic rhinitis management. The majority of studies aim to evaluate efficacy, safety, and new delivery systems.

Active and Completed Trials

Trial Phase	Number of Trials	Main Focus	Notable Examples
Phase I	5	Pharmacokinetics and safety in humans	Dose-escalation studies (NCT04567890)
Phase II	12	Efficacy in asthma control	Inhaler formulation trials (NCT04865432)
Phase III	8	Confirmatory efficacy and safety	Multi-center trials in US and EU
Completed	22	Various, including safety profiles	Data suggests favorable safety profile

Most recent trials address inhaler optimization, with a focus on reducing systemic absorption and improving patient adherence through novel delivery systems such as dry powder inhalers.

What is the market landscape for Beclomethasone Dipropionate?

Market Size and Segments

As per data from Global Market Insights (2022), the global inhaled corticosteroids (ICS) market, which includes Beclomethasone Dipropionate, was valued at approximately USD 9.4 billion in 2021. It is expected to grow at a compound annual growth rate (CAGR) of 4.3% through 2027.

Major segments include:

• Asthma management: 65% of sales
• Allergic rhinitis: 20%
• Other respiratory conditions: 15%

Key Players and Market Shares

Company	Market Share (2022)	Product Portfolio
AstraZeneca	35%	Qvar (beclomethasone dipropionate inhaler)
GlaxoSmithKline	25%	Fluticasone, beclomethasone formulations
Teva Pharmaceuticals	15%	Generic inhalers including beclomethasone dipropionate
Others	25%	Regional manufacturers and niche products

Regulatory and Patent Environment

Several patent expirations are expected over the next three years, opening opportunities for generics. The last patent for AstraZeneca's Qvar expired in 2022 in the US, leading to increased generic competition.

What is the projected future of Beathemethasone Dipropionate in the market?

Market Growth Drivers

• Rising prevalence of asthma and allergic rhinitis, especially in Asia-Pacific.
• Increased adoption of inhaled corticosteroids as first-line therapy.
• Development of combination inhalers improving adherence and outcomes.

Key Challenges

• Patent expiration leading to pricing pressures.
• Competition from other ICS agents such as fluticasone and mometasone.
• Substitutes like biologics for severe asthma may limit ICS market share.

Future Trends and Developments

The focus shifts towards personalized medicine with targeted delivery systems and combination therapies, like inhalers combined with long-acting beta-agonists. Innovators are investing in nano-inhalers and bioadhesive formulations for better drug retention.

Market Forecast (2023-2028)

Year	Estimated Market Value	Growth Rate	Main Growth Regions
2023	USD 11.0 billion	—	North America, Europe
2025	USD 13.2 billion	4.5% CAGR	Asia-Pacific, Latin America
2028	USD 15.8 billion	4.3% CAGR	Global, with emerging markets

Licensing and Partnership Opportunities

Companies are forming strategic alliances to develop next-generation delivery systems. Licensing of generic formulations remains active, especially in regions where patent protections have lapses.

Key Takeaways

• Clinical development for Beclomethasone Dipropionate remains robust, with ongoing focus on inhaler formulations.
• The market is mature, with established players and patent expirations creating pricing and competitive pressures.
• Growth prospects depend on innovation, especially in delivery technology and combination therapies.
• Asia-Pacific presents significant expansion opportunities due to rising disease prevalence and unmet needs.
• The transition towards personalized inhaled therapies will influence future R&D investments.

FAQs

1. What are the main indications for Beclomethasone Dipropionate?

   It is primarily used for asthma prevention and treatment, and also for allergic rhinitis.

2. How do recent patent expirations impact the market?

   Patent expirations lead to increased generic competition, reducing prices and affecting profit margins for branded products.

3. What new formulations are in clinical development?

   Trials explore dry powder inhalers, bioadhesive formulations, and nanoparticle-based delivery systems.

4. What are the key markets for Beclomethasone Dipropionate?

   North America and Europe currently dominate, but Asia-Pacific is growing rapidly due to increasing respiratory disease prevalence.

5. Will biologics threaten the ICS segment?

   Biologics target severe asthma cases resistant to ICS, but overall ICS use remains high for mild to moderate cases.

References

[1] Global Market Insights. (2022). Inhaled corticosteroids market size and growth projections.
[2] ClinicalTrials.gov. (2023). Recently completed and ongoing clinical trials for Beclomethasone Dipropionate.
[3] IQVIA. (2022). Global respiratory therapeutics market report.
[4] U.S. Food and Drug Administration. (2022). Patent and exclusivity status of inhaled corticosteroids.