CLINICAL TRIALS PROFILE FOR FLUTICASONE PROPIONATE

505(b)(2) Clinical Trials for FLUTICASONE PROPIONATE

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	NCT00364442 ↗	Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics	Completed	GlaxoSmithKline	Phase 1	2005-01-28	A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.
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.
New Formulation	NCT01255579 ↗	Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma	Completed	Università degli Studi di Brescia	Phase 4	2007-07-01	New formulations of extrafine particles of long acting beta-2 agonists+inhaled corticosteroids (LABA+ICS) are able to reach more peripheral regions of the lung. Objectives.The aim of this study was to assess the effect on small airways obstruction of long-term treatments with two different LABA+ICS combinations in asthma. Patients and methods.Ten subjects with moderate persistent asthma were enrolled. After a 4-week washout they were treated in a randomized cross-over design for 24 weeks with formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d. (FB) or salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d. (SF). At baseline and at the end of each period subjects underwent Asthma Control Test (ACT) and Pulmonary Function Testing. The N2 phase III slope and closing volume (CV) during single breath washout test, and DElta(Heliox-air)MEF50% were measured to assess changes on peripheral airways function.

All Clinical Trials for FLUTICASONE PROPIONATE

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.
NCT00071552 ↗	Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients	Terminated	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 4	2004-01-01	The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.
NCT00071552 ↗	Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients	Terminated	Teva Branded Pharmaceutical Products, R&D Inc.	Phase 4	2004-01-01	The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.
NCT00102765 ↗	Study Of Asthma In Patients Of African Descent	Completed	GlaxoSmithKline	Phase 4	2004-11-01	This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)

Clinical Trial Conditions for FLUTICASONE PROPIONATE

Condition Name

Condition Name for FLUTICASONE PROPIONATE
Intervention	Trials
Asthma	157
Pulmonary Disease, Chronic Obstructive	45
Allergic Rhinitis	18
Seasonal Allergic Rhinitis	17

Condition MeSH

Condition MeSH for FLUTICASONE PROPIONATE
Intervention	Trials
Asthma	158
Lung Diseases	72
Pulmonary Disease, Chronic Obstructive	71
Lung Diseases, Obstructive	60

Clinical Trial Locations for FLUTICASONE PROPIONATE

Trials by Country

Trials by Country for FLUTICASONE PROPIONATE
Location	Trials
Germany	217
Italy	77
Argentina	61
Mexico	57
Australia	53

Trials by US State

Trials by US State for FLUTICASONE PROPIONATE
Location	Trials
California	101
Texas	98
Florida	90
South Carolina	84
North Carolina	81

Clinical Trial Progress for FLUTICASONE PROPIONATE

Clinical Trial Phase

Clinical Trial Phase for FLUTICASONE PROPIONATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE1	1

Clinical Trial Status

Clinical Trial Status for FLUTICASONE PROPIONATE
Clinical Trial Phase	Trials
Completed	292
Recruiting	19
Terminated	16

Clinical Trial Sponsors for FLUTICASONE PROPIONATE

Sponsor Name

Sponsor Name for FLUTICASONE PROPIONATE
Sponsor	Trials
GlaxoSmithKline	141
Teva Branded Pharmaceutical Products R&D, Inc.	18
Respirent Pharmaceuticals Co Ltd.	17

Sponsor Type

Sponsor Type for FLUTICASONE PROPIONATE
Sponsor	Trials
Industry	369
Other	137
NIH	9

Clinical Trials Update, Market Analysis, and Projection for Fluticasone Propionate

Last updated: October 28, 2025

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Introduction

Fluticasone Propionate is an intranasal corticosteroid widely prescribed for allergic rhinitis, nasal polyps, and atopic dermatitis. As a key player in allergy and respiratory therapeutics, its development, regulatory landscape, and market trajectory warrant detailed analysis. This report offers an in-depth update on ongoing clinical trials, evaluates current market dynamics, and projects future opportunities for Fluticasone Propionate within the global pharmaceutical sphere.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen significant clinical activity focused on optimizing Fluticasone Propionate’s efficacy, safety, and delivery mechanisms. The primary areas include:

• New Formulation Development: Multiple trials, such as NCT04615941 (promoting enhanced mucosal absorption), are exploring novel delivery systems like nanoparticle-based nasal sprays. These aim to increase bioavailability while reducing required dosages.

• Expanded Indications: Trials assessing Fluticasone Propionate's efficacy in pediatric populations, particularly in children under age 4, are underway. For example, NCT04988386 investigates safety and dosing parameters for pediatric allergic rhinitis.

• Combination Therapies: Several studies are testing Fluticasone Propionate combined with antihistamines or leukotriene receptor antagonists to evaluate synergistic effects (e.g., NCT04471369).

• Long-term Safety & Pharmacovigilance: Post-market surveillance programs and longitudinal studies, such as NCT04527344, are assessing adverse effects in chronic use, ensuring safety profiles remain favorable.

Regulatory Milestones

While Fluticasone Propionate has established approval globally, regulatory agencies continue to evaluate new formulations and indications:

• The European Medicines Agency (EMA) approved Fluticasone Propionate nasal spray for pediatric use above age 4, following submission of new safety data from recent trials.

• The U.S. Food and Drug Administration (FDA) remains attentive to ongoing pharmacovigilance reports, with no major safety concerns thus far, encouraging further research into optimized therapies.

Market Landscape and Analysis

Current Market Size

The global Fluticasone Propionate market was valued at approximately $1.2 billion in 2022, with a compound annual growth rate (CAGR) of 4.5% projected over the next five years ([1]). North America dominates, accounting for around 45% of the market share, driven by high prevalence rates of allergic rhinitis and established healthcare infrastructure.

Key Market Players

Leading pharmaceutical companies include:

• GlaxoSmithKline (GSK): Proprietor of Flonase, a leading intranasal corticosteroid product.

• AstraZeneca: ENGAGED in novel formulation development and regional expansion, particularly in emerging markets.

• Teva Pharmaceutical Industries: Focused on generic Fluticasone Propionate formulations with cost-sensitive strategies.

Emerging players also seek to leverage delivery innovations and expand into niche indications such as nasal polyps and pediatric allergies.

Market Drivers

• Rising Prevalence of Allergic Diseases: The WHO estimates global allergic rhinitis affects over 400 million people, fueling demand for effective treatment options[2].

• Patient Preference for Non-oral Delivery: Intranasal corticosteroids like Fluticasone Propionate offer targeted therapy with fewer systemic effects, improving compliance.

• Introduction of Generic Alternatives: Patent expirations stimulate market entry of generics, expanding accessibility while altering revenue streams for branded products.

• Regulatory Support and Expanding Indications: Approval of formulations for pediatric use and new delivery platforms broadens market potential.

Market Challenges

• Competitive Landscape: The presence of multiple corticosteroids (e.g., mometasone, budesonide) creates pricing pressures and limits market share for individual brands.

• Safety Concerns: Long-term corticosteroid use raises concerns about potential systemic effects, impacting prescribing patterns.

• Regional Disparities: Limited access in low-income regions hampers global market penetration, despite high disease burden.

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Future Market Projection

Growth Outlook (2023-2028)

The Flu­ticasone Propionate market is expected to grow at a CAGR of 4-6%, reaching approximately $1.6 billion by 2028. Key factors influencing this include:

• Innovative Delivery Platforms: Liposomal, nanoparticle, and bioadhesive formulations will enhance efficacy and patient adherence.

• Expansion into Emerging Markets: Asia-Pacific and Latin America are projected to witness higher growth rates (8-10%), driven by increasing healthcare access and rising allergic disease prevalence.

• Evolving Therapeutic Indications: Beyond allergic rhinitis, interest in treating nasal polyps, sinusitis, and COPD with Fluticasone Propionate will foster market expansion.

• Combination Therapies: Multi-drug nasal sprays combining corticosteroids with antihistamines will become increasingly popular.

Regulatory and Commercial Opportunities

Companies investing in next-generation formulations, personalized medicine approaches, and region-specific marketing strategies are well-positioned to capitalize on upcoming trends. The development of long-acting formulations and minimally invasive delivery devices could further accelerate adoption.

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Key Considerations for Stakeholders

• Patent Lifecycle: While initial patents on Fluticasone Propionate have expired, new formulations and delivery systems are often patent-protected, creating opportunities for differentiation.

• Pricing Strategies: Achieving competitive pricing through generics and biosimilars will be crucial, particularly in price-sensitive markets.

• Regulatory Compliance: Maintaining rigorous post-marketing surveillance and safety reporting will be essential for ongoing approvals and market access.

• Research Investment: Ongoing clinical innovation, especially around pediatric and combination therapies, remains vital for long-term market sustainability.

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Key Takeaways

• Robust Clinical Activity: Recent and ongoing trials focus on enhancing delivery, expanding indications, and ensuring long-term safety, underpinning future therapeutic growth.

• Market Maturity and Growth Potential: The global Fluticasone Propionate market is mature but offers expanding opportunities through innovation, regional penetration, and emerging indications.

• Competitive Landscape Dynamics: Patent expirations and generics have increased price competition; innovation in delivery and formulation remains a key differentiator.

• Regulatory and Safety Considerations: Enhanced safety profiles in pediatric populations and long-term use are critical to maintaining market confidence.

• Future Growth Drivers: Adoption of novel formulations, combination therapies, and expansion into emerging markets will propel growth toward the late 2020s.

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FAQs

1. What are the key clinical advantages of Fluticasone Propionate over other corticosteroids?
   Fluticasone Propionate offers superior local anti-inflammatory effects with minimal systemic absorption, leading to effective symptom control and a favorable safety profile—particularly important in chronic use scenarios.

2. Are there any ongoing clinical trials exploring new indications for Fluticasone Propionate?
   Yes. Current studies investigate its efficacy for nasal polyps, sinusitis, and pediatric allergic rhinitis, aiming to broaden its therapeutic spectrum.

3. How do patent expirations impact Fluticasone Propionate’s market prospects?
   Patent expirations open avenues for generic formulations, increasing accessibility but also intensifying competition. Innovation in delivery systems helps sustain branded market share.

4. What challenges does Fluticasone Propionate face in emerging markets?
   Limited healthcare infrastructure, awareness, and affordability hinder market penetration despite rising disease prevalence. Local manufacturing and pricing strategies are essential.

5. What future innovations could influence Fluticasone Propionate’s market growth?
   The development of long-acting formulations, targeted delivery devices, and combination therapies are poised to enhance efficacy, adherence, and overall market adoption.

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References

[1] MarketWatch. (2023). Global Corticosteroids Market Size & Share.
[2] World Health Organization. (2022). The Global Allergy Epidemic.