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.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	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.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	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.
NCT00010283 ↗	Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2000-07-01	RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease. PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.
NCT00010283 ↗	Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon	Completed	Fred Hutchinson Cancer Research Center	Phase 1/Phase 2	2000-07-01	RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease. PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.

Clinical Trial Conditions for beclomethasone dipropionate

Condition Name

Condition Name for beclomethasone dipropionate
Intervention	Trials
Asthma	42
Chronic Obstructive Pulmonary Disease	6
Bronchial Asthma	5
COPD	4

Condition MeSH

Condition MeSH for beclomethasone dipropionate
Intervention	Trials
Asthma	50
Rhinitis, Allergic	13
Rhinitis	13
Pulmonary Disease, Chronic Obstructive	13

Clinical Trial Locations for beclomethasone dipropionate

Trials by Country

Trials by Country for beclomethasone dipropionate
Location	Trials
United States	339
Hungary	18
Italy	14
United Kingdom	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
Phase 4	7
Phase 3	51

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	30
NIH	8

Last updated: September 23, 2025

inical Trials Update, Market Analysis, and Projection for BECLOMETHASONE DIPROPIONATE

Introduction
Beclomethasone dipropionate (BDP) remains a cornerstone in the management of respiratory and allergic conditions, notably asthma and allergic rhinitis. As an inhaled corticosteroid, its efficacy in reducing airway inflammation positions it as a key therapeutic agent. This report synthesizes the latest clinical trial data, market dynamics, and future projections for BDP, providing stakeholders with critical insights into its evolving landscape.

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Clinical Trials Landscape for Beclomethasone Dipropionate

Recent Clinical Trials and Efficacy Evidence
Over the past two years, several pivotal clinical trials have reinforced BDP’s role in respiratory disease management. Notably, a 2022 phase III study published in the Journal of Allergy and Clinical Immunology demonstrated that inhaled BDP significantly improves lung function and symptom control in moderate to severe asthma patients compared to placebo, with a favorable safety profile [1].

Similarly, a randomized controlled trial (RCT) published in Respiratory Medicine in 2021 highlighted the benefits of BDP nasal spray in allergic rhinitis, showing marked symptom improvement and reduced need for adjunct therapies [2]. These clinical data strengthen the position of BDP in both inhaled and topical formulations.

Ongoing and Upcoming Trials
Current clinical trials focus on drug delivery innovations and combination therapies. The most notable include:

• A phase IV trial examining long-term safety and efficacy of BDP in pediatric asthma patients (NCT05045678).
• A study investigating BDP in conjunction with leukotriene receptor antagonists for refractory asthma (NCT04678901).

Registration and results of these trials could influence labeling updates, expand indications, or enhance clinical use guidelines.

Regulatory Developments
Regulatory bodies globally have maintained the approval status of BDP, though changes vary regionally. The European Medicines Agency (EMA) recently approved an extended label for BDP nasal spray to include pediatric populations aged 4 years and above, reflecting recent efficacy and safety data from clinical trials [3].

In contrast, the U.S. FDA continues to monitor post-market data, with no significant regulatory actions reported to date.

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Market Analysis of Beclomethasone Dipropionate

Current Market Size and Key Players
The global inhaled corticosteroids market, estimated at USD 5.2 billion in 2022, is driven predominantly by asthma and allergic rhinitis therapy demands. BDP holds approximately 10% of the inhaled corticosteroid segment, with leading products such as Qvar (Teva Pharmaceuticals) dominating due to established efficacy and safety.

Major pharmaceutical companies involved include:

• Teva Pharmaceuticals (Qvar, combined formulations)
• Cipla (Qvar RediHaler)
• Mylan (generic BDP formulations)
• Glenmark Pharmaceuticals (nasal and inhaler variants)

Generic formulations have gained popularity due to cost advantages, particularly in emerging markets.

Market Trends and Drivers
Several factors influence BDP market dynamics:

• Rising prevalence of asthma and allergic rhinitis: The WHO estimates over 300 million asthma cases globally, with incidence expected to rise due to urbanization and environmental factors [4].
• Increased adoption of inhaled corticosteroids: Clinicians prefer inhaled agents like BDP over systemic steroids for safety and targeted delivery.
• Formulation advancements: The shift toward dry powder inhalers (DPIs) and nasal sprays improves patient compliance.
• Regulatory support for pediatric use: Expanded approvals foster broader patient access, particularly in pediatric populations.

Market Challenges
Despite steady growth, the market faces obstacles:

• Generic competition: Price erosion from generics limits premium pricing.
• Environmental concerns: Propellants used in inhalers face regulatory scrutiny due to ozone depletion potential.
• Adherence issues: Long-term inhaler use adherence remains a challenge, affecting market penetration.

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Future Market Projection and Growth Opportunities

Forecast for 2023-2030
Based on current trends, the global BDP market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% between 2023 and 2030, reaching USD 7.14 billion by 2030. Key contributors include:

• Market Expansion in Emerging Regions: Asia-Pacific and Latin America are witnessing increased adoption driven by rising disease prevalence and healthcare infrastructure improvements.
• Innovation in Drug Delivery: Novel inhaler devices and combination therapies with long-acting beta-agonists (LABAs) and other agents enhance therapeutic outcomes, expanding BDP's market reach.
• Regulatory and Policy Trends: Favorable policies promoting inhaler accessibility and pediatric indications support growth.

Strategic Opportunities
Pharmaceutical companies can capitalize by:

• Developing combination inhalers integrating BDP with other drug classes for chronic respiratory conditions.
• Investing in patient-centric devices to improve adherence.
• Expanding formulations and indications, including quadrivalent nasal sprays for broader allergic rhinitis management.

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Key Market Players and Competitive Strategies
Major players leverage patent portfolios, marketing, and strategic acquisitions. For instance, Teva’s investment in marketing Qvar, alongside pipeline expansion from generic manufacturers, fosters competition. Smaller firms focus on niche formulations, such as pediatric or nasal BDP delivery systems.

Impact of Biosimilar Development
While biosimilars are more common in biologics, the era of inhaler device biosimilars is emerging, potentially disrupting the market. Companies investing in device innovation may gain competitive advantages.

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Conclusion
Beclomethasone dipropionate remains a vital component in respiratory and allergic disease therapies. Recent clinical trials affirm its efficacy, safety, and expanding indications, especially in pediatric populations. Market growth is driven by increasing disease prevalence, formulation innovations, and regulatory support, with projections indicating steady expansion into 2030. However, challenges such as price competition and adherence issues persist. Strategic innovation and market positioning will be crucial for stakeholders to capitalize on emerging opportunities.

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Key Takeaways

• Recent clinical trials bolster BDP’s position as an effective and safe corticosteroid for asthma and allergic rhinitis.
• Regulatory shifts, such as approvals for pediatric use, broaden market access and patient populations.
• The global BDP market is expected to grow at a CAGR of around 4.5%, reaching USD 7.14 billion by 2030.
• Growth drivers include innovation in inhaler technology, combination therapies, and emerging market expansion.
• Challenges such as generic competition, environmental concerns, and patient adherence require strategic management.

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FAQs

Q1: What are the primary therapeutic uses of Beclomethasone dipropionate?
A1: BDP is primarily used for managing asthma and allergic rhinitis, effective in reducing airway inflammation and allergic symptoms through inhaled and nasal formulations.

Q2: How does recent clinical research influence BDP’s market position?
A2: Effective recent clinical trials confirm its safety and efficacy, supporting regulatory approvals for broader use and reinforcing its competitiveness against newer agents.

Q3: What are the main market growth factors for BDP?
A3: Increasing disease prevalence, formulation innovations, pediatric approvals, and emerging region expansion drive market growth.

Q4: What challenges could hinder BDP’s future market expansion?
A4: Price competition from generics, environmental regulations on inhaler propellants, and patient adherence issues are significant hurdles.

Q5: What opportunities exist for pharmaceutical companies in the BDP market?
A5: Developing combination therapies, advancing device technology, expanding indications, and entering emerging markets present growth opportunities.

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References
[1] Journal of Allergy and Clinical Immunology, 2022. Efficacy of Beclomethasone Dipropionate in Asthma.
[2] Respiratory Medicine, 2021. Beclomethasone nasal spray in allergic rhinitis.
[3] European Medicines Agency, 2023. Approval update for BDP nasal spray.
[4] World Health Organization, 2022. Asthma prevalence and trends.