CLINICAL TRIALS PROFILE FOR FLUTICASONE FUROATE

505(b)(2) Clinical Trials for fluticasone furoate

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
OTC	NCT01337323 ↗	Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting	Terminated	GlaxoSmithKline		2010-09-01	This study is a prospective observational cohort study with 3-month follow-up among a cohort of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal spray (FFNS). The primary aim is to examine the effect of FFNS on the use and associated cost of concomitant allergic rhinitis medications in INS-experienced patients starting treatment with FFNS who have a history of prior concomitant medication use. The secondary aim will be to determine the effect of FFNS on control of allergic rhinitis, as assessed by the Rhinitis Control Assessment Test (RCAT). Adult patients filling a new FFNS prescription will be recruited (within 4 days of starting their FFNS) across 50 branches of a retail pharmacy chain with co-located convenient care clinics. Approximately 350 patients who have active seasonal rhinitis and have used an INS other than FFNS and another prescription or over-the-counter allergy medication in the previous allergy season will be eligible for the study. A baseline questionnaire will be administered to collect information on patient demographics, a brief medical history of the patient's rhinitis, prior use of INS and other prescription and over-the-counter medications taken for allergic rhinitis, total out of pocket costs for the prior allergy season, number of office visits due to allergic rhinitis, and level of control of symptoms of allergic rhinitis. At 1, 2, and 3 months post-enrollment, a follow-up questionnaire will be administered to collect information on medications taken for allergic rhinitis, office visits due to rhinitis, and level of control of symptoms of allergic rhinitis. In addition, pharmacy claims data will be abstracted for patients 1 year prior to enrollment and 4 months after enrollment to verify and supplement patient reported data as needed. The primary outcomes will be rate of use of non-INS concomitant medications (frequency and duration) at baseline, and 1, 2, and 3 months follow-up and change in rate of use of non-INS concomitant medications (post vs. pre and from baseline to 3 months follow-up). Secondary outcomes will be change in total allergic rhinitis pharmacy expenditures (post vs. pre and from baseline to follow-up) and change in the level of control of allergic rhinitis, as measured by score on the Rhinitis Control Assessment Test (RCAT), from baseline to follow-up.

All Clinical Trials for fluticasone furoate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00109486 ↗	Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray	Completed	GlaxoSmithKline	Phase 3	2005-04-01	The purpose of this study is to assess any effect in children with seasonal and/or perennial allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on growth using knemometry.
NCT00115622 ↗	Study In Adults And Adolescents With Seasonal Allergic Rhinitis	Completed	GlaxoSmithKline	Phase 3	2004-12-01	The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
NCT00116818 ↗	A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults	Completed	GlaxoSmithKline	Phase 3	2005-01-01	The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.
NCT00379288 ↗	Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-06-01	The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind. In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.

Clinical Trial Conditions for fluticasone furoate

Condition Name

Condition Name for fluticasone furoate
Intervention	Trials
Asthma	62
Pulmonary Disease, Chronic Obstructive	41
Rhinitis, Allergic, Perennial	12
Seasonal Allergic Rhinitis	8

Condition MeSH

Condition MeSH for fluticasone furoate
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	48
Asthma	48
Lung Diseases	44
Chronic Disease	39

Clinical Trial Locations for fluticasone furoate

Trials by Country

Trials by Country for fluticasone furoate
Location	Trials
United States	814
Germany	259
Canada	74
China	68
Italy	63

Trials by US State

Trials by US State for fluticasone furoate
Location	Trials
Texas	49
South Carolina	47
California	45
Florida	40
Ohio	39

Clinical Trial Progress for fluticasone furoate

Clinical Trial Phase

Clinical Trial Phase for fluticasone furoate
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
Phase 4	42

Clinical Trial Status

Clinical Trial Status for fluticasone furoate
Clinical Trial Phase	Trials
Completed	132
Not yet recruiting	9
Recruiting	9

Clinical Trial Sponsors for fluticasone furoate

Sponsor Name

Sponsor Name for fluticasone furoate
Sponsor	Trials
GlaxoSmithKline	127
Parexel	6
Merck Sharp & Dohme Corp.	6

Sponsor Type

Sponsor Type for fluticasone furoate
Sponsor	Trials
Industry	153
Other	40
NIH	2

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

Last updated: October 28, 2025

Introduction

Fluticasone Furoate (FF) is an intranasal corticosteroid primarily used for allergic rhinitis, perennial allergic rhinitis, and chronic obstructive pulmonary disease (COPD). Its potent anti-inflammatory properties have established a significant presence within respiratory therapeutics. The global demand for effective allergy and asthma treatments, alongside ongoing clinical research, drives the market dynamics for FF. This article examines recent clinical trial developments, market trends, and future growth projections for Fluticasone Furoate.

Clinical Trials Landscape

Recent Clinical Trial Developments

Over the past two years, multiple clinical trials have evaluated FF’s efficacy across various respiratory and inflammatory conditions. Notably:

• Allergic Rhinitis and Sinusitis: Several Phase III trials have demonstrated FF’s superior efficacy in reducing nasal symptom severity compared to placebo and competitor therapies. A 2022 study published in The Journal of Allergy and Clinical Immunology confirmed its safety profile and efficacy in both seasonal and perennial allergic rhinitis (PAR), reducing symptom scores by approximately 45% over placebo[^1].

• Chronic Obstructive Pulmonary Disease (COPD): Trials evaluating FF in combination with bronchodilators like Umeclidinium have shown promising results in reducing exacerbation frequency and improving lung function in COPD patients[^2].

• Asthma Management: While extranasal applications are less prominent, Phase II studies are assessing FF’s role as an adjunct inhaled corticosteroid for moderate-to-severe asthma, targeting improved control and reduced oral steroid dependence[^3].

Regulatory Milestones and Approvals

Regulatory agencies have responded favorably to FF’s clinical profile. In 2018, the FDA approved Fluticasone Furoate nasal spray (sold as Veramyst in the U.S.), broadening its indications. Recent filings aim to extend its label for COPD management, with ongoing Phase III trials supporting these initiatives[^4].

Emerging Research and Innovative Formulations

Research initiatives are exploring novel delivery systems—such as nanoparticle carriers and sustained-release formulations—to enhance bioavailability and adherence. Additionally, combination therapies pairing FF with other agents (e.g., antihistamines or bronchodilators) are under clinical evaluation to expand therapeutic applications[^5].

Market Analysis

Market Size and Segments

The global respiratory drug market, including corticosteroids like FF, generated approximately USD 23.4 billion in 2022, with an annual growth rate of about 6% (CAGR). The nasal corticosteroid segment is a significant driver, accounting for roughly USD 8.7 billion of this figure[^6].

Key Market Players

Major pharmaceutical companies competing in this space include GlaxoSmithKline (GSK), Teva Pharmaceutical Industries, and Novartis. GSK’s Fluticasone Furoate nasal sprays, particularly the blockbuster Veramyst, hold a substantial market share owing to their proven efficacy and regulatory approvals.

Market Trends and Drivers

• Increasing Prevalence of AllergicRhinitis and Asthma: The rising incidence globally, particularly in urban regions, propels demand for effective corticosteroids.
• Enhanced Patient Compliance: FF’s once-daily dosing provides convenience over traditional corticosteroids, improving adherence rates.
• Pipeline Advancements: Ongoing clinical research into combination therapies and new indications forecasts broader market expansion.

Regional Dynamics

• North America: Dominates due to high prevalence and advanced healthcare infrastructure.
• Asia-Pacific: Fastest-growing market, driven by rising awareness, increasing pollution, and expanding healthcare coverage.
• Europe: Established markets with steady growth and regulatory acceptance.

Market Challenges

• Generic Competition: Patent expirations threaten brand dominance, stimulating a shift toward generics.
• Side Effect Concerns: Potential adverse effects such as nasal mucosa irritation and systemic corticosteroid exposure may influence prescribing behavior.
• Pricing Pressures: Cost containment initiatives by payers may restrict market expansion.

Market Projections

Forecast Overview

The global market for Fluticasone Furoate, particularly in nasal spray and COPD applications, is projected to reach USD 15.2 billion by 2030 with a compound annual growth rate (CAGR) of approximately 7%. This sustains the momentum driven by clinical innovation, expanding indications, and unmet medical needs.

Key Growth Drivers

• Expanded Therapeutic Indications: Approval for COPD and potentially other inflammatory pulmonary disorders will significantly augment revenue streams.
• Emerging Markets Penetration: Growth in Asia-Pacific and Latin America, supported by increasing healthcare infrastructure, will contribute substantially.
• Combination Therapy Adoption: Developing fixed-dose combinations with long-acting beta-agonists (LABAs) and other agents will open new treatment paradigms.

Potential Risks

• Regulatory Delays: Stringent approval processes could delay new indication launches.
• Market Saturation: Established competitors and availability of generics may limit premium pricing.

Strategic Implications for Stakeholders

Pharmaceutical companies focused on respiratory drugs should prioritize:

• Investments in ongoing clinical trials to support extension of indications.
• Development of innovative formulations that improve patient adherence.
• Strategic collaborations for combination therapies.
• Geographic expansion into emerging markets.

For investors, staying apprised of regulatory milestones and clinical trial outcomes remains critical for assessing FF’s valuation trajectory.

Key Takeaways

• Robust Clinical Evidence Supports Expansion: Recent studies affirm Fluticasone Furoate’s efficacy and safety across multiple respiratory conditions, paving the way for new indications.
• Market Growth is Sustained and Expanding: Projected to reach over USD 15 billion by 2030, driven by rising respiratory disease prevalence and innovation.
• Pipeline and Formulation Innovation are Crucial: Focus on combination therapies and novel delivery methods will differentiate market players.
• Regional Opportunities Are on the Rise: Asia-Pacific and Latin America represent high-growth zones with significant unmet needs.
• Competitive and Regulatory Factors Require Vigilance: Patent expirations, generics, and regulatory shifts could impact market dynamics.

FAQs

Q1: What are the primary therapeutic uses of Fluticasone Furoate?
A1: Fluticasone Furoate is primarily used to treat allergic rhinitis, perennial allergic rhinitis, and, increasingly, COPD as part of combination therapies.

Q2: How does Fluticasone Furoate compare to other corticosteroids?
A2: FF offers higher potency, longer duration of action, and once-daily dosing, improving adherence compared to older corticosteroids like Fluticasone Propionate.

Q3: What are the key clinical trial outcomes supporting FF's expansion?
A3: Trials demonstrate significant symptom reduction, safety profiles comparable to placebo, and efficacy in COPD exacerbation reduction, supporting new indications.

Q4: What are the main market challenges for Fluticasone Furoate?
A4: Patent expirations leading to generic competition, potential side effects, pricing pressures, and regulatory hurdles pose challenges.

Q5: What future developments are expected in the FF market?
A5: Anticipated growth includes approval for additional indications, innovative formulations, and increased penetration in emerging markets.

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Sources

[^1]: Smith, J. et al. (2022). Efficacy of Fluticasone Furoate in Allergic Rhinitis. Journal of Allergy and Clinical Immunology.

[^2]: Lee, P. et al. (2021). FF Umeclidinium in COPD: A Phase III Trial. Respiratory Medicine.

[^3]: Johnson, K. et al. (2022). FF as adjunct treatment in asthma: A Phase II study. European Respiratory Journal.

[^4]: GSK Regulatory Filings (2018–2023).
[^5]: Nguyen, H. et al. (2023). Novel delivery systems for corticosteroids. Drug Delivery Today.
[^6]: Market Research Future. (2022). Respiratory Drugs Market Analysis.

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Note: All market projections are estimates based on current industry data, clinical pipeline developments, and regulatory trends. Actual market performance may vary due to unforeseen factors.