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.

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	159
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
China	54

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
PHASE2	1

Clinical Trial Status

Clinical Trial Status for FLUTICASONE PROPIONATE
Clinical Trial Phase	Trials
Completed	292
Recruiting	20
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	370
Other	137
NIH	9

FLUTICASONE PROPIONATE Market Analysis and Financial Projection

Last updated: April 28, 2026

Fluticasone Propionate: Clinical-Trials Update, Market Analysis, and Forward Projections

What is fluticasone propionate’s current clinical-trial posture?

Fluticasone propionate is an established, off-patent corticosteroid with a long marketed history across inhaled and intranasal regimens for asthma, COPD, allergic rhinitis, and chronic rhinosinusitis indications. Clinical activity is dominated by:

• New formulations and delivery systems (device or particle-engineering changes that target lung or nasal deposition, dosing convenience, and adherence).
• Line extensions in common respiratory pathways (adult and pediatric subpopulations; add-on use with bronchodilators or other controllers; outcomes aligned to symptom control and exacerbation reduction).
• Bioequivalence and bridging studies for formulation/device changes rather than de novo efficacy pivots.

Clinical-trials signal (public registries, by category):	Trial type pattern	Typical objective	Common endpoints
Formulation/device modifications	Improve deposition, reduce variability, support fixed dosing	Pharmacokinetics (PK), symptom score, lung function (FEV1), reliever use
Population targeting	Pediatric dosing, geriatric safety, comorbidity subsets	Safety/tolerability, asthma control, nasal symptom scales
Combination regimens	Add-on controller therapy	Exacerbation rate, standardized control indices
Bridging studies	Compare to reference product post-change	Bioequivalence, local tolerability

Practical read-through for R&D and investors

• The late-stage “value creation” in fluticasone propionate largely comes from system-level improvements (device, particle size, or regimen simplification) and label expansions that differentiate from legacy equivalents.
• De novo superiority trials are less common than in originator IP-heavy biologics, because the active ingredient is widely available and constrained by competitive benchmarking.

What does the market look like today?

Fluticasone propionate is a mature global respiratory franchise anchored in two major commercial lanes:

1. Inhaled fluticasone for asthma/COPD
2. Intranasal fluticasone for allergic rhinitis and related upper-airway disease

Demand drivers

• High prevalence of asthma and allergic rhinitis and long-term controller usage.
• Guideline inclusion of inhaled corticosteroids (ICS) for asthma and intranasal corticosteroids (INCS) for rhinitis.
• Switching and replenishment cycles in chronic care: consistent repeat purchasing supports baseline demand even as competitors trade share.

Competitive structure

• Market is characterized by multiple branded products, generics, authorized equivalents, and device-specific variants.
• Pricing pressure is typical at the ingredient level, while differentiation persists around device performance, dosing convenience, and payer positioning.

Representative product categories (how the market is segmented)

Segment	Examples of marketed product forms	Buyer decision factors
Inhaled ICS (single or fixed-dose combos)	Metered-dose inhalers (MDIs), dry powder inhalers (DPIs), breath-actuated platforms	Device inhaler technique, adherence, formulary tiering
Intranasal corticosteroids	Aqueous sprays, suspension sprays	Onset of symptom relief, dosing schedule, tolerability
Fixed combinations	ICS with long-acting bronchodilators (where applicable)	Exacerbation reduction claims, guideline concordance

Where is pricing and share most likely to move?

Across mature ICS and INCS products, the dominant share-impact mechanisms are:

• Formulary contracting and tier placement
• Generic and authorized generic entry cycles
• Device differentiation claims (especially where errors in technique reduce real-world efficacy)
• Patient preference shifts tied to dosing frequency, plume/odor perceptions (intranasal), and inhaler handling

Directional expectations

• Ingredient-level price erosion continues where generics dominate.
• More durable price support is typically found in combo products and in device-driven systems that show better adherence and fewer technique failures in real-world settings.
• Intranasal categories are generally more competitive than inhaled controller markets but can hold share due to high switching costs once patients are stable.

What is the realistic growth outlook for fluticasone propionate?

Growth in mature small-molecule respiratory products is usually a mix of:

• Unit growth (population growth, diagnosis rates, adherence improvement)
• Share shifts (device differentiation and formulary wins)
• Price offsets (contracting and generic pressure balancing premium positions)

Projection framework (high-level)

Because fluticasone propionate is widely marketed and API-level competition is entrenched, projection credibility depends on how the portfolio evolves via:

• New device/formulation launches
• Combination regimen uptake
• Geographic formulary penetration
• Regulatory label expansions that create differentiation beyond “same ingredient”

Market projection (directional)

• Near term (12 to 24 months): steady baseline demand with modest growth driven by device and payer positioning; margin pressure where generics expand.
• Medium term (2 to 5 years): growth tracks respiratory guideline adherence programs and fixed-combination uptake; premium positions concentrate where delivery systems reduce technique failure and improve adherence.
• Long term (5+ years): mature plateau characteristics dominate; incremental growth comes from lifecycle management (new platforms) rather than major clinical breakthroughs.

How should investors and R&D teams underwrite fluticasone propionate differentiation?

Underwriting should treat fluticasone propionate as an “execution market” where the moat is not the drug molecule. The levers are:

• Device performance and usability evidence (human factors testing, adherence modeling, real-world technique improvement)
• Local tolerability and patient experience (intranasal tolerability, throat symptoms, cough incidence patterns)
• Formulary strategy (rebates, switching restrictions, preferred formulary status)
• Bridging package quality (tight evidence to support rapid lifecycle changes across geographies)

What is the competitive and regulatory implication of the drug’s maturity?

For fluticasone propionate, regulatory pathways for lifecycle changes typically focus on:

• Bioequivalence (when appropriate)
• Demonstration of clinical similarity via bridging to labeled performance in targeted endpoints
• Safety/tolerability confirmations aligned to the delivery route

This means timelines and costs for lifecycle programs are often shorter than for de novo clinical development, but differentiation must be measurable to win payer and prescriber preference.

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Key Takeaways

• Fluticasone propionate clinical activity is dominated by formulation and delivery-system lifecycle trials and bridging/bioequivalence evidence, not brand-new therapeutic mechanisms.
• The market is mature and structurally competitive, with growth mainly driven by unit demand, adherence, device differentiation, and fixed-combination penetration, offset by generic pricing pressure.
• Forward projections should underwrite value through device and portfolio execution (formulary wins, dosing convenience, usability evidence), not through molecule-level innovation.

FAQs

1) Is fluticasone propionate still seeing meaningful clinical trials?
Yes, most activity centers on formulation/device changes, bridging, and subpopulation or regimen optimization rather than de novo mechanism-driven development.

2) What drives market share for fluticasone products now?
Formulary tiering, contracting dynamics, and device usability that improves real-world dosing consistency.

3) Where is growth most likely within fluticasone’s addressable market?
In segments where fixed combinations and delivery improvements translate into better adherence and guideline-concordant use.

4) How sensitive is fluticasone revenue to generic competition?
High at the ingredient and single-molecule level; better resilience tends to correlate with device differentiation and combination products.

5) What evidence most often supports lifecycle launches?
Bioequivalence, local tolerability, PK/PD consistency, and clinical bridging endpoints aligned to labeled performance.

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References

[1] Global Initiative for Asthma (GINA). (n.d.). Global Strategy for Asthma Management and Prevention. https://ginasthma.org/
[2] Global Initiative for Chronic Obstructive Lung Disease (GOLD). (n.d.). Global Strategy for Prevention, Diagnosis and Treatment of COPD. https://goldcopd.org/
[3] Allergic Rhinitis and its Impact on Asthma (ARIA). (n.d.). Allergic rhinitis and its impact on asthma guidelines. https://www.arialliance.org/