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	41
Chronic Obstructive Pulmonary Disease	6
Bronchial Asthma	5

Condition MeSH

Condition MeSH for BECLOMETHASONE DIPROPIONATE
Intervention	Trials
Asthma	49
Rhinitis, Allergic	13
Rhinitis	13

Clinical Trial Locations for BECLOMETHASONE DIPROPIONATE

Trials by Country

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−

Trials by Country for BECLOMETHASONE DIPROPIONATE
Location	Trials
United States	339
Hungary	18
United Kingdom	14
Italy	14
Poland	13

Trials by US State

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−

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
Phase 4	7
Phase 3	51
Phase 2	18

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	29
NIH	8

Beclomethasone Dipropionate: Clinical Trials, Market Analysis, and Projections

Introduction to Beclomethasone Dipropionate

Beclomethasone dipropionate (BDP) is a synthetic corticosteroid widely used in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). It is administered primarily through inhalation, reducing inflammation in the airways and improving breathing and quality of life for patients.

Clinical Trials and Efficacy

Breath-Actuated Inhalers (BAI) vs. Metered-Dose Inhalers (MDI)

A significant clinical trial compared the efficacy and safety of BDP administered via breath-actuated inhalers (BAI) and metered-dose inhalers (MDI). This 6-week, phase III, double-blind study involved patients aged 12 years and older with persistent asthma. The results showed that BDP BAI significantly improved pulmonary function, including forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF), compared to placebo. These improvements were similar to those achieved with BDP MDI, indicating that BAI is a viable and effective alternative that eliminates the need for hand-breath coordination[1].

Comparative Study with Triamcinolone Acetonide

Another study compared the efficacy and safety of BDP with triamcinolone acetonide (TA) in adults with mild to moderately severe persistent asthma. This 56-day, randomized, double-blind trial found that BDP was at least as effective as TA in improving FEV1 and reducing asthma symptom scores and the use of rescue albuterol. BDP demonstrated superior results in some measures, such as mean increase in FEV1 and total asthma symptom scores[3].

Safety Profile

Both clinical trials highlighted that BDP has a favorable safety profile. The study comparing BDP BAI and BDP MDI found that BDP BAI was well tolerated with no new safety signals, similar to BDP MDI[1]. The comparative study with TA also showed that BDP and TA had comparable safety profiles, with no significant adverse effects reported[3].

Market Analysis

Market Growth and Drivers

The global beclomethasone dipropionate market is anticipated to grow significantly over the forecast period (2024-2031). The primary drivers of this growth include the increasing prevalence of respiratory disorders such as asthma and COPD, particularly in industrial areas where pollution is higher. The market is also driven by advancements in aerosol delivery technology, rising awareness of respiratory health, and government initiatives to improve healthcare access[2][5].

Market Size and CAGR

The market is expected to register a substantial CAGR in terms of revenue, with the global market size projected to reach significant figures by the end of the forecast period. For instance, the market was anticipated to reach a certain value by 2024 from a lower value in 2019, indicating robust growth[2].

Regional Analysis

The Beclomethasone Dipropionate aerosols market exhibits diverse growth patterns across different regions. North America, particularly the United States, holds a dominant position due to high incidence rates of asthma and COPD, along with advanced healthcare systems. Europe also shows significant growth driven by increasing awareness and government initiatives. The Asia-Pacific region is emerging as a lucrative market due to rising pollution levels and urbanization, while Latin America and the Middle East present challenges related to economic disparities and varying healthcare access levels[5].

Market Opportunities and Challenges

Opportunities

The market presents several opportunities for growth, including:

• Innovative Formulations and Delivery Systems: The development of smart inhalers and other advanced delivery systems can enhance patient adherence and treatment outcomes.
• Emerging Markets: Regions like Asia-Pacific and Latin America offer untapped potential due to the rising prevalence of respiratory diseases.
• Partnerships and Awareness Campaigns: Collaborations with healthcare providers and organizations can promote the benefits of BDP among patients and caregivers[5].

Challenges

Despite the opportunities, the market faces some challenges:

• Economic Disparities: Variations in healthcare access and economic conditions in certain regions can impact market growth.
• Regulatory Environments: Different regulatory environments across regions can affect the approval and adoption of BDP aerosols[5].

Competitive Analysis

The Beclomethasone Dipropionate market is competitive, with several key players involved in the development and distribution of BDP aerosols. Companies are focusing on innovative formulations, advanced delivery systems, and strategic partnerships to gain a competitive advantage. The market's competitive dynamics are influenced by factors such as product innovation, pricing strategies, and regulatory approvals[2][5].

Regulatory and Government Initiatives

Government initiatives aimed at improving respiratory health through awareness campaigns and subsidized medications are positively impacting the market. Regulatory approvals and increased investments in respiratory care are also supporting the growth of the Beclomethasone Dipropionate aerosols market[5].

Patient-Centered Care and Personalized Medicine

The increasing focus on patient-centered care and personalized medicine opens avenues for tailored therapies that cater to individual patient needs. This trend is expected to drive the development of more effective and patient-friendly BDP formulations and delivery systems[5].

Key Takeaways

• Clinical Efficacy: BDP has been shown to be highly effective in improving pulmonary function and reducing asthma symptoms in clinical trials.
• Safety Profile: BDP has a favorable safety profile, comparable to other inhaled corticosteroids.
• Market Growth: The global BDP market is expected to grow significantly driven by the increasing prevalence of respiratory disorders and advancements in technology.
• Regional Variations: Market growth varies by region, with North America and Europe leading, and Asia-Pacific emerging as a key market.
• Opportunities and Challenges: The market offers opportunities in innovative formulations and emerging markets but faces challenges related to economic disparities and regulatory environments.

FAQs

What is Beclomethasone Dipropionate used for?

Beclomethasone Dipropionate is used for the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD) by reducing inflammation in the airways.

How is Beclomethasone Dipropionate administered?

BDP is primarily administered through inhalation using devices such as metered-dose inhalers (MDI) or breath-actuated inhalers (BAI).

What are the key drivers of the Beclomethasone Dipropionate market growth?

The market growth is driven by the increasing prevalence of respiratory disorders, advancements in aerosol delivery technology, rising awareness of respiratory health, and government initiatives to improve healthcare access.

Which regions are leading the Beclomethasone Dipropionate market?

North America, particularly the United States, and Europe are currently leading the market, while the Asia-Pacific region is emerging as a significant growth area.

What are the potential challenges facing the Beclomethasone Dipropionate market?

The market faces challenges related to economic disparities, varying levels of healthcare access, and different regulatory environments across regions.

Sources

1. Randomized trial to assess the efficacy and safety of beclomethasone dipropionate administered via breath-actuated inhaler versus metered-dose inhaler in patients with persistent asthma. PubMed.
2. Beclomethasone Dipropionate Market 2024| By Key Players. OpenPR.
3. Comparative clinical study of inhaled beclomethasone dipropionate and triamcinolone acetonide in adults with persistent asthma. PubMed.
4. Beclomethasone Dipropionate Effect on Adrenal Function in Asthma. Columbia University.
5. Beclomethasone Dipropionate Aerosols Market Size, Growth and Forecast. Data Horizon Research.