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	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.
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	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.

All Clinical Trials for FLUTICASONE PROPIONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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)
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.
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.

Clinical Trial Conditions for FLUTICASONE PROPIONATE

Condition Name

Condition Name for FLUTICASONE PROPIONATE
Intervention	Trials
Asthma	155
Pulmonary Disease, Chronic Obstructive	45
Allergic Rhinitis	18
Seasonal Allergic Rhinitis	17

Condition MeSH

Condition MeSH for FLUTICASONE PROPIONATE
Intervention	Trials
Asthma	156
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	216
Italy	77
Argentina	60
Mexico	57
Australia	53

Trials by US State

+

−

Trials by US State for FLUTICASONE PROPIONATE
Location	Trials
California	98
Texas	95
Florida	88
South Carolina	82
North Carolina	80

Clinical Trial Progress for FLUTICASONE PROPIONATE

Clinical Trial Phase

Clinical Trial Phase for FLUTICASONE PROPIONATE
Clinical Trial Phase	Trials
Phase 4	105
Phase 3	109
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for FLUTICASONE PROPIONATE
Clinical Trial Phase	Trials
Completed	290
Recruiting	17
Terminated	16

Clinical Trial Sponsors for FLUTICASONE PROPIONATE

Sponsor Name

Sponsor Name for FLUTICASONE PROPIONATE
Sponsor	Trials
GlaxoSmithKline	141
Respirent Pharmaceuticals Co Ltd.	17
Teva Branded Pharmaceutical Products R&D, Inc.	16

Sponsor Type

Sponsor Type for FLUTICASONE PROPIONATE
Sponsor	Trials
Industry	366
Other	136
NIH	9

Fluticasone Propionate: Clinical Trials, Market Analysis, and Projections

Introduction to Fluticasone Propionate

Fluticasone propionate (FP) is a potent androstane glucocorticoid widely used for its anti-inflammatory properties, particularly in the treatment of respiratory conditions such as asthma and allergic rhinitis. Its efficacy and safety profile have made it a cornerstone in the management of these diseases.

Clinical Potency and Mechanism of Action

FP is known for its high clinical potency, exceeding that of other inhaled corticosteroids like beclomethasone dipropionate and budesonide by at least two-fold. This potency is attributed to its high lipophilicity, which enhances its uptake, binding, and retention in human lung tissue. FP demonstrates rapid receptor association and slow receptor dissociation, contributing to its strong glucocorticoid receptor selectivity and affinity[1].

Clinical Applications

Asthma

FP is highly effective in managing asthma when administered via inhalation. Clinical studies have shown significant improvements in lung function, reduced bronchial reactivity, and lower exacerbation rates. It also has an oral corticosteroid-sparing effect, which is crucial for minimizing systemic side effects[1].

Allergic Rhinitis

Intranasal administration of FP is effective in treating seasonal and perennial allergic rhinitis. It inhibits T lymphocyte proliferation, cytokine generation, and other inflammatory processes, providing marked vasoconstrictor potency and reducing mucosal inflammation[1].

Eosinophilic Esophagitis (EoE)

Eupraxia Pharmaceuticals is conducting a phase 1b/2a trial to evaluate the safety, tolerability, and efficacy of endoscopically targeted injections of FP for EoE. This condition, characterized by chronic inflammation of the esophagus, has limited treatment options, and FP could offer a novel and effective solution[3].

Ongoing and Completed Clinical Trials

Asthma Trials

Teva Pharmaceuticals completed a phase 3 long-term safety study (FSS-AS-305) evaluating the safety of FP multidose dry powder inhaler (MDPI) and FP/salmeterol MDPI in patients with persistent asthma. The study involved patients aged 12 and older and ran from 2014 to 2015[4].

EoE and Osteoarthritis Trials

Eupraxia Pharmaceuticals is currently conducting trials for EoE and osteoarthritis using their proprietary drug delivery technology. The EoE trial involves injecting FP directly into the affected esophageal tissues, while the osteoarthritis trial evaluates the safety and efficacy of FP in treating knee osteoarthritis[3].

Market Analysis and Projections

Global Market Overview

The global fluticasone propionate market is expected to grow significantly over the next few years. The market is driven by increasing demand for effective treatments for respiratory diseases and other inflammatory conditions.

Key Players

Major players in the fluticasone propionate market include GlaxoSmithKline (GSK), Teva, West-Ward Pharmaceuticals, Apotex Corp., Akorn, and Wockhardt. These companies are instrumental in manufacturing and distributing various formulations of FP[5].

Market Segmentation

The market is segmented by type (e.g., 60, 120, and 150 metered sprays) and application (adult and pediatric use). The North American market, in particular, is projected to grow at a significant CAGR from 2023 to 2030[5].

Revenue and Growth Projections

The global fluticasone propionate market is forecasted to increase in value, with the North American segment expected to contribute substantially to this growth. The market report by Valuates Reports provides detailed revenue and volume forecasts, company shares, and competitive landscapes[5].

Market Dynamics and Drivers

Increasing Prevalence of Respiratory Diseases

The rising incidence of asthma and allergic rhinitis globally is a key driver for the fluticasone propionate market. As the population grows and urbanization increases, the demand for effective treatments for these conditions is expected to rise.

Advancements in Drug Delivery Technology

Innovations in drug delivery, such as Eupraxia Pharmaceuticals' technology for targeted injections, are enhancing the efficacy and safety of FP treatments. These advancements are likely to expand the market by offering better patient outcomes and compliance[3].

Regulatory Environment

Favorable regulatory environments and approvals for new formulations and delivery methods are also driving the market growth. For instance, the completion of phase 3 trials and subsequent approvals can significantly boost market penetration[4].

Challenges and Limitations

Systemic Side Effects

While FP has a favorable therapeutic index with minimal systemic effects compared to other corticosteroids, long-term use can still lead to side effects such as oral candidiasis and adrenal suppression. These risks necessitate careful patient monitoring and management[1].

Patient Compliance

Ensuring patient compliance, especially with inhaled formulations, can be challenging. Proper education and the development of user-friendly devices are crucial to maximizing the benefits of FP treatment.

Future Pipeline and Potential Indications

Inflammatory Joint Indications

Eupraxia Pharmaceuticals is exploring the use of FP in other inflammatory joint conditions beyond osteoarthritis, leveraging their drug delivery technology to provide localized and sustained relief[3].

Oncology

There is potential for FP to be used in oncology, particularly in reducing inflammation associated with cancer treatments. This area is under investigation and could expand the market further.

Key Takeaways

• Clinical Potency: FP is highly potent, exceeding other inhaled corticosteroids in clinical efficacy.
• Clinical Applications: Effective in asthma, allergic rhinitis, and potentially EoE and osteoarthritis.
• Market Growth: Driven by increasing demand for respiratory disease treatments and advancements in drug delivery technology.
• Key Players: GSK, Teva, West-Ward Pharmaceuticals, Apotex Corp., Akorn, and Wockhardt.
• Future Pipeline: Potential indications in inflammatory joint conditions and oncology.

FAQs

What is the primary use of fluticasone propionate?

Fluticasone propionate is primarily used for the treatment of asthma and allergic rhinitis through inhalation or intranasal administration.

How does fluticasone propionate compare to other corticosteroids?

FP has at least twice the clinical potency of beclomethasone dipropionate and budesonide without a significant increase in systemic effects, indicating a higher therapeutic index[1].

What are the ongoing clinical trials for fluticasone propionate?

Current trials include a phase 1b/2a trial for eosinophilic esophagitis and ongoing phase 2 trials for osteoarthritis using Eupraxia Pharmaceuticals' drug delivery technology[3].

Who are the major players in the fluticasone propionate market?

Key players include GSK, Teva, West-Ward Pharmaceuticals, Apotex Corp., Akorn, and Wockhardt[5].

What are the projected market growth and revenue for fluticasone propionate?

The global market is expected to grow significantly, with the North American segment projected to increase at a notable CAGR from 2023 to 2030[5].

Sources

1. Fluticasone propionate--an update on preclinical and clinical ... - PubMed
2. Global Fluticasone Propionate Market 2024 by Manufacturers ... - Market Research Reports
3. Eupraxia Pharmaceuticals Doses First Patient in Phase 1b/2a ... - Eupraxia Pharmaceuticals
4. NCT02175771 - Home - Teva Pharmaceuticals - Teva Pharmaceuticals
5. Global Fluticasone Propionate Market Research ... - Valuates Reports