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.

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

Fluticasone Furoate Market Analysis and Financial Projection

Last updated: April 25, 2026

Fluticasone Furoate: Clinical Trial Update, Market Analysis, and 2025-2035 Projection

What is fluticasone furoate and which products drive the market?

Fluticasone furoate (FF) is an inhaled corticosteroid used in respiratory disease, most prominently asthma and chronic obstructive pulmonary disease (COPD). In commercial practice, FF market revenue is dominated by branded, proprietary-delivery products and follow-on generics where applicable.

Primary marketed FF brands by indication (global):

• Asthma: Arnuity Ellipta (FF dry powder inhaler, DPI), Trelegy Ellipta (FF in combination for COPD, used in asthma in some jurisdictions depending on label)
• COPD: Breo Ellipta (FF plus vilanterol), Trelegy Ellipta (FF plus umeclidinium plus vilanterol in multiple geographies)

Geographic commercialization pattern:

• Strongest adoption is in the US and EU where Ellipta device penetration and payer formularies support steady inhaled corticosteroid (ICS) continuity.
• Emerging market growth is paced by formulary conversion, respiratory specialty access, and generic competition in component classes (ICS molecules).

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What do current clinical-trial updates indicate for FF?

A complete, up-to-the-week clinical-trial update requires a live registry pull. With no registry feed provided here, only high-confidence, well-established FF clinical programs can be stated as current directions. This is a market analysis task, not a registry audit.

Most business-relevant ongoing FF clinical themes (therapeutic class direction):

• Optimization of inhaler regimens in asthma and COPD to reduce exacerbations
• Real-world outcomes generation for adherence, exacerbation rates, and healthcare utilization (payer-relevant endpoints)
• Subgroup refinement (elderly, severe asthma, COPD phenotypes) to align with guideline-based step therapy
• Combination strategy durability for LABA and LAMA/LABA-ICS fixed-dose products, where FF is a core ICS component

Commercial inference from the FF development model:

• FF’s lifecycle strategy has historically centered on fixed-dose combinations and device-anchored regimens that improve adherence and reduce regimen complexity (DPI once-daily designs in Ellipta line). That pattern continues to shape development priorities because payer and guideline behaviors reward simplification.

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How does FF compete in the inhaled corticosteroid landscape?

FF competes within the ICS and ICS combination ecosystem against:

• Other steroid molecules in DPI/HFA delivery (e.g., fluticasone propionate, budesonide, mometasone class products where available)
• Fixed-dose ICS/LABA combinations with once-daily or twice-daily dosing
• Triple therapy (ICS/LABA/LAMA) where FF is an ICS anchor in Trelegy-type regimens

Key competitive drivers that determine FF share:

1. Device performance and adherence (once-daily regimen compliance)
2. Payer formulary position (preferred brand status, step-therapy rules)
3. Exacerbation economics (use-case is driven by hospital and steroid burst cost avoidance)
4. Patent and exclusivity timelines that affect generic pressure and pricing

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Market analysis

How big is the FF opportunity and where does growth come from?

FF growth is not best modeled as a single-molecule market because sales flow through combination products and devices. The actionable approach for projection is to track:

• Asthma controller demand (ICS and ICS/LABA)
• COPD controller and escalation demand (ICS/LABA and triple therapy)
• Brand share persistence where formularies keep FF-based combinations preferred
• Generic displacement risk in ICS monotherapy and in some geographic markets for component molecules

Market demand engines:

• Continued COPD prevalence management and guideline adherence for exacerbation prevention
• Escalation from dual therapy to triple therapy in higher-risk COPD cohorts
• Asthma controller inertia (patients stay on established regimens unless cost or clinical failures force switching)

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What is the pricing and access dynamic for FF?

FF-based brands generally operate under:

• Tiered payer coverage where combinations face higher cost-sharing but get preferred placements when supported by utilization and outcomes
• Switch incentives where payers encourage step substitution to lower-cost ICS or generics once clinical stability is achieved
• Trade-up protection when FF-based combinations retain guideline-recommended status for severe or high-exacerbation risk patients

Business implication:

• The market is “sticky” in controlled patients. Growth comes mostly from new patient starts, step-up escalations, and conversions from older inhaler devices, not from wholesale substitution.

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What are the key patent and exclusivity constraints affecting FF projections?

A projection hinges on competitive entry windows. Without a live patent chart here, a defensible method is to treat FF projections as:

• Near-term: driven by ongoing brand coverage and fixed-dose combinations
• Mid-term: exposed to generic pressure where molecule-level exclusivity ends and where payers move to lower-cost controllers
• Long-term: dependent on whether FF maintains its role in triple therapy and whether device ecosystems sustain adherence advantages

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2025-2035 market projection

Base-case projection (global FF-containing inhaler combinations)

Forecast framing (unit economics driven, not molecule-only):

• Growth comes from asthma controller expansion and COPD escalation, offset by generic penetration in monotherapy and selective substitution in combination classes.

Projected global growth range for FF-containing inhaler revenues (directional base case):

• 2025-2030: mid-single-digit annual growth (annualized)
• 2030-2035: lower growth (high-single-digit taper to mid-single-digit or low-single-digit) as mature-market substitution and pricing pressure increase

Regional pattern expected:

• US/EU: moderate growth with payer-driven erosion risk
• China and broader APAC: higher growth from increasing diagnosis and controller penetration, tempered by local formulary strategies and competitive intensity
• LATAM and MEA: faster baseline adoption where access expands, but margins can compress through tendering and reimbursement constraints

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Scenario table: 2025-2035 revenue trajectory

Ranges express directional risk for FF-containing inhaler revenues, not an exact CAGR point estimate.

Scenario	2025-2030 Growth	2030-2035 Growth	Primary drivers
Downside	Low to mid-single-digit	Low-single-digit	Faster payer switching, higher discounting, increased generic substitution in ICS classes
Base case	Mid-single-digit	Low to mid-single-digit	Balanced payer stickiness, ongoing step-up to combinations, moderate price pressure
Upside	High-single-digit	Mid-single-digit	Better-than-expected persistence in triple therapy cohorts, stronger APAC penetration, limited generic substitution impacts

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Clinical pipeline-to-market translation

Even without a live registry pull, FF’s market logic links to:

• Fixed-dose combination retention in asthma and COPD escalation pathways
• Adherence benefits that preserve persistence and reduce treatment discontinuation
• Real-world endpoints that support payer renewal and preferred formulary positioning

Where these elements hold, FF tends to sustain share and revenue despite class competition. Where payers re-optimize after exclusivity windows, molecule-level pricing pressure spreads through the combination portfolio.

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Key Takeaways

• Fluticasone furoate is commercially anchored in Ellipta fixed-dose inhaler combinations for asthma and COPD; market performance is driven by combination share, device persistence, and payer coverage, not molecule-only usage.
• Clinical direction that matters for revenue remains focused on exacerbation reduction, step-up therapy performance, and real-world adherence outcomes, consistent with FF’s fixed-dose, device-led strategy.
• 2025-2035 growth is best modeled as moderate in early years and slower after maturity, with downside risk from payer switching and generics in ICS classes and upside risk from sustained triple-therapy conversions and APAC controller penetration.
• The most business-critical variable in projection is formulary behavior post-exclusivity, since FF’s “stickiness” is strongest in controlled patients and weaker when payers restructure incentives.

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FAQs

1. Is fluticasone furoate mainly sold as a standalone inhaled steroid?
   No. The largest sales contribution typically comes through fixed-dose FF-containing combination inhalers used for asthma and COPD management.

2. What market segment drives the strongest FF revenue growth?
   COPD controller escalation, especially where patients move toward higher-risk regimens and where FF-based triple therapy remains preferred.

3. What is the main threat to FF market share?
   Payer-driven switching to lower-cost ICS alternatives and increased generic or preferred-list substitution in mature markets.

4. How do clinical outcomes influence FF market access?
   Inhaler persistence and exacerbation reductions translate into payer renewal decisions and step-therapy rules, which can sustain or erode market share.

5. What matters most for 2030-2035 projections?
   The pace of price erosion and formulary redesign after exclusivity windows, combined with whether FF retains its position in combination therapy ecosystems.

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References

[1] FDA. Breo Ellipta (fluticasone furoate and vilanterol) prescribing information.
[2] FDA. Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol) prescribing information.
[3] FDA. Arnuity Ellipta (fluticasone furoate) prescribing information.
[4] GINA. Global Strategy for Asthma Management and Prevention. Latest guideline version available.
[5] GOLD. Global Initiative for Chronic Obstructive Lung Disease. Latest guideline version available.