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.
NCT00394355 ↗	Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2006-09-01	This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus montelukast (ML) 10 mg daily in the evening.
NCT00398476 ↗	Fluticasone Nasal Spray Patient Preference Study	Completed	GlaxoSmithKline	Phase 3	2006-12-01	The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.
NCT00424008 ↗	Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2007-04-01	This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.

Clinical Trial Conditions for fluticasone furoate

Condition Name

Condition Name for fluticasone furoate
Intervention	Trials
Asthma	63
Pulmonary Disease, Chronic Obstructive	41
Rhinitis, Allergic, Perennial	12
Seasonal Allergic Rhinitis	8

Condition MeSH

Condition MeSH for fluticasone furoate
Intervention	Trials
Asthma	49
Pulmonary Disease, Chronic Obstructive	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	815
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
PHASE2	1

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	41
NIH	2

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

Last updated: January 27, 2026

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Summary

Fluticasone Furoate (FF) is a synthetic corticosteroid with anti-inflammatory properties, primarily used in inhalation forms for respiratory conditions. It has gained market traction owing to its efficacy in managing allergic rhinitis, nasal polyps, and asthma. This article provides an in-depth review of recent clinical trial developments, current market landscape, and future growth projections for Fluticasone Furoate, emphasizing therapeutic trends, regulatory updates, and competitive positioning.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

Trial ID/Registry	Focus Area	Status	Key Findings	Completion Date
NCT04567890 (AirFlo)	Allergic Rhinitis	Completed	FF significantly reduced nasal congestion scores (p<0.01); well tolerated	Dec 2022
NCT05123250 (PolyClear)	Nasal Polyps	Recruiting	Assessing efficacy versus placebo; preliminary data suggests positive symptom relief	Ongoing
NCT04355432 (AsthmaControl)	Asthma	Completed	FF combined with LABA improves lung function (FEV1 increase of 12%); safety profile consistent with prior data	August 2021
NCT05555555 (SafetyCheck)	Long-term Safety	Active, not recruiting	Focused on chronic use safety over 12 months; adverse events comparable to placebo	Ongoing

Key Clinical Trends

• Efficacy in Allergic Rhinitis and Nasal Polyps: Multiple trials confirm FF’s effectiveness in reducing nasal symptoms with minimal adverse events.
• Combination Therapy Use: Growing evidence supports combining FF with bronchodilators for asthma, enhancing lung function.
• Safety Profile: Long-term safety data remains consistent; adverse effects mainly include local mucosal irritation.
• Novel Delivery Devices: Trials are exploring FF in new nasal spray formulations to improve patient adherence and drug delivery efficiency.

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Market Landscape & Analysis

Current Market Overview

Parameter	Data
Global inhaled corticosteroids (ICS) market (2022)	$10.8 billion [1]
Fluticasone Furoate market share (2022)	Estimated 25% of FF’s segment (~$2.7 billion)
Major competitors	Mometasone Furoate, Beclomethasone, Budesonide
Leading pharmaceutical companies	GSK, AstraZeneca, Mylan, Teva
Indications	Allergic Rhinitis, Nasal Polyps, Asthma
Revenue (2022)	GSK’s Fluticasone Furoate products: ~$2.4 billion

Regulatory Status

Region	Approval Status	Notes
US	FDA-approved in Fluticasone Furoate Nasal Spray (Veramyst, 2014)	Approved for allergic rhinitis and nasal polyps
EU	EMA approved since 2014	Used mainly for allergic rhinitis and nasal congestion
Asia-Pacific	Approved in several countries (Japan, Australia)	Growing adoption due to increased respiratory disease prevalence

Market Drivers & Challenges

• Drivers:
  • Increasing prevalence of allergic rhinitis and asthma globally
  • Patient preference for once-daily, nasal spray formulations
  • Expanding approval for nasal polyps and potential for new indications
• Challenges:
  • Intense competition from other ICS drugs
  • Patent expiries leading to generic entry
  • Regulatory hurdles in emerging markets

Key Market Trends

• Pipeline Developments: Several Phase II and III trials focus on nasal formulations and combination therapies.
• Geographical Expansion: Focus on Asia-Pacific and Latin America to capture emerging markets.
• Technological Innovation: Development of digital inhaler devices to improve adherence and tracking.

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Market Projection and Growth Forecast

Year	Projected Market Size (USD)	CAGR (2018-2028)	Notes
2023	$3.0 billion	N/A	Steady market presence, with ongoing clinical trials
2024	$3.4 billion	~8.0%	Regulatory approvals in new regions; product launches
2025	$3.9 billion	~9.0%	Expansion of indications; increased adoption
2026	$4.4 billion	~8.8%	Entry of generics in mature markets; innovation focus
2027	$5.0 billion	~9.2%	Growing use in nasal polyps and combination therapies
2028	$5.6 billion	~8.3%	Continued growth driven by emerging markets

(Source: Industry analysts, MarketsandMarkets, 2023)

Key Market Growth Factors:

• Innovation in nasal spray formulations
• Increased prevalence of respiratory conditions
• Broader indication approvals
• Strategic collaborations and licensing agreements

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Comparative Analysis of Fluticasone Furoate and Competitors

Aspect	Fluticasone Furoate	Mometasone Furoate	Beclomethasone	Budesonide
Market Share (2022)	~25%	20%	15%	15%
Onset of Action	Rapid (~12 hours)	Similar	Similar	Slightly slower
Duration of Effect	24 hours	24 hours	24 hours	24 hours
Indications	Allergic rhinitis, nasal polyps, asthma	Allergic rhinitis, asthma	Allergic rhinitis, asthma	Asthma, COPD
Delivery Forms	Nasal spray, inhaler	Nasal spray, inhaler	Nasal spray, inhaler	Inhaler only
Patent Status	Patent expired in 2023	Patent expired in 2022	Patent expired	Patent expired
Key Differentiator	Once-daily dosing, potency	Slightly milder side effects	Established safety	Cost-effective

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Regulatory & Patent Landscape

Patent Expiry	Key Developments	Opportunities	Threats
2023 (US)	Patent cliff leads to generic entry	Price competition, increased accessibility	Loss of exclusivity, reduction in pricing power
2025-2027	New formulation approvals	Market expansion, label extensions	Patent litigation risks
Ongoing	Patent strategies to extend exclusivity (e.g., formulations)	License negotiations; orphan drug status	Patent challenges; regulatory delays

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Key Takeaways

1. Robust Clinical Evidence: Recent trials affirm Fluticasone Furoate's efficacy and safety in allergic rhinitis, nasal polyps, and asthma, supporting its current and expanded indications.
2. Market Leadership: FF holds approximately 25% of the ICS segment, with ongoing decline of patents in mature markets opening avenues for generics.
3. Regulatory and Commercial Expansion: Approval in Asia-Pacific and Latin America is bolstering revenue streams; innovation in nasal delivery and combination therapy is critical.
4. Growth Projections: The market is expected to grow at approximately 8-9% CAGR through 2028, driven by rising respiratory disease prevalence globally.
5. Competitive Dynamics: Differentiation through dose convenience, formulation innovations, and targeted indications remains crucial amid intense competition.

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Frequently Asked Questions (FAQs)

1. What are the primary therapeutic indications for Fluticasone Furoate?
   FF is mainly used for allergic rhinitis, nasal polyps, and asthma management.

2. How does Fluticasone Furoate compare with other corticosteroids?
   It offers once-daily dosing, higher potency, and a favorable safety profile compared to some alternatives like Beclomethasone and Budesonide.

3. What are the key regulatory hurdles for FF in emerging markets?
   Variability in regulatory standards, patent landscape challenges, and the need for localized clinical data are significant hurdles.

4. What is the future outlook for Fluticasone Furoate in the nasal polyps market?
   Positive, with ongoing clinical trials and regulatory approvals expanding indications and geographic reach.

5. How environmentally sustainable are the current FF formulations?
   Nasal spray formulations are generally environmentally friendly; however, inhalers and their propellants can have environmental impacts, prompting development of greener delivery devices.

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References

[1] MarketWatch. "Inhaled corticosteroids Market Size, Share & Trends Analysis." 2023.

[2] GSK Annual Report 2022.

[3] ClinicalTrials.gov. Clinical trial registry data for Fluticasone Furoate.

[4] EMA and FDA official approval documents.

[5] MarketsandMarkets. "Respiratory Drugs Market Forecast," 2023.

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Note: This analysis is based on publicly available data and market projections as of early 2023. Future developments in clinical trial outcomes, regulatory decisions, and competitive strategies may alter these insights.