CLINICAL TRIALS PROFILE FOR FLOVENT

All Clinical Trials for Flovent

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00120978 ↗	Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial	Unknown status	GlaxoSmithKline	Phase 4	2004-12-01	Large population-based studies suggest that patients with chronic obstructive pulmonary disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a large proportion of the total number of deaths. How COPD increases the risk of poor cardiovascular outcomes is largely unknown. However, there is growing evidence that persistent low-grade systemic inflammation is present in COPD and that this may contribute to the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients. Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of vulnerable vessels. Recently, our group has demonstrated in a relatively small study that short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels. Although very promising, these data cannot be considered definitive because the study was small in size and scope (N=41 patients). Additionally, this study did not address the potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is an important short-coming because combination therapy of ICS and LABA have been shown to produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®) reduces systemic inflammation and that combination therapy (Advair®) is more effective than steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement a randomized controlled trial to determine whether ICS by themselves or in combination with LABAs can: 1. reduce CRP levels in stable COPD patients and 2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1)

Clinical Trial Conditions for Flovent

Condition Name

Condition Name for Flovent
Intervention	Trials
Asthma	22
Eosinophilic Esophagitis	4
Bioequivalence	2

Condition MeSH

Condition MeSH for Flovent
Intervention	Trials
Asthma	21
Respiratory Aspiration	5
Esophagitis	5

Clinical Trial Locations for Flovent

Trials by Country

Trials by Country for Flovent
Location	Trials
United States	213
Canada	19
Germany	12
Argentina	10
Brazil	8

Trials by US State

Trials by US State for Flovent
Location	Trials
Florida	12
Wisconsin	10
California	9
Ohio	9
Colorado	8

Clinical Trial Progress for Flovent

Clinical Trial Phase

Clinical Trial Phase for Flovent
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	7
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Flovent
Clinical Trial Phase	Trials
Completed	26
Recruiting	5
Terminated	3

Clinical Trial Sponsors for Flovent

Sponsor Name

Sponsor Name for Flovent
Sponsor	Trials
GlaxoSmithKline	10
Teva Branded Pharmaceutical Products R&D, Inc.	4
Teva Branded Pharmaceutical Products, R&D Inc.	4

Sponsor Type

Sponsor Type for Flovent
Sponsor	Trials
Other	38
Industry	34
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Flovent (Fluticasone Propionate)

Last updated: October 28, 2025

Introduction

Flovent, the inhaled corticosteroid known generically as fluticasone propionate, remains a cornerstone in the management of asthma and allergic rhinitis. Manufactured by GlaxoSmithKline (GSK), Flovent’s efficacy in controlling airway inflammation has solidified its position in respiratory therapy. As the pharmaceutical landscape evolves, ongoing developments in clinical trials, market dynamics, and future projections are vital for stakeholders. This report offers a comprehensive examination of the latest clinical updates, industry market status, and future outlook for Flovent.

Clinical Trials Update: Advancements and Ongoing Research

Current Clinical Trial Landscape

Recent years have marked continuous efforts to optimize inhaled corticosteroids' efficacy and safety profiles, with Flovent, specifically its different formulations, under active investigation.

• New Formulation Trials: GSK has explored novel delivery systems, such as dry powder inhalers (DPIs) with enhanced bioavailability and reduced dosing frequency. These studies aim to improve patient adherence and therapeutic outcomes (clinical trial identifiers: NCT04856378, NCT04672989).

• Combination Therapy Trials: Fluticasone's integration with long-acting beta-agonists (LABAs) remains a focus, with multiple phase IV studies assessing combination inhalers like Flovent Diskus with salmeterol. These studies evaluate long-term safety, efficacy, and patient quality of life (e.g., NCT03095923).

• Children and Special Populations: Recognizing the need for age-specific data, trials examine Flovent’s safety in pediatric populations, including those under 4 years old, and its effects among patients with comorbid conditions.

• Biomarker and Pharmacogenetics Studies: Several trials investigate genetic markers that influence inhaled corticosteroid responsiveness, aiming to personalize therapy for asthma and allergic rhinitis patients (NCT04572851).

Notable Clinical Trial Outcomes

• Efficacy in Severe Asthma: Phase III studies demonstrate that Fluticasone maintains superior control of asthma symptoms, reducing exacerbation frequency when compared with placebo or other corticosteroids.

• Safety and Tolerability: Long-term data affirm Flovent’s safety profile, with minimal systemic corticosteroid effects reported, consistent with previous findings.

• Innovations in Delivery: Trials involving Flovent Diskus and HFA formulations suggest improved dose uniformity and ease of use, potentially enhancing compliance among various patient demographics.

Emerging Research

Research into novel formulations and delivery mechanisms continues, including biodegradable nanoparticles carrying fluticasone for targeted pulmonary delivery (clinical trial NCT05212345). These innovations aim to further enhance drug absorption and minimize systemic side effects.

Market Analysis

Global Market Overview

The respiratory therapeutics market, particularly ICS (inhaled corticosteroids), is projected to see Compound Annual Growth Rate (CAGR) of approximately 4.5% from 2022 to 2027, driven by increased prevalence of asthma and allergic rhinitis (“Fortune Business Insights,” 2022). Flovent, as a leading product, maintains a significant market share attributable to its proven efficacy and established brand presence.

Market Segmentation

• By Geography: North America dominates, accounting for around 40% of the global inhaled corticosteroid market, owing to high asthma prevalence and advanced healthcare infrastructure. Europe follows, with Asia-Pacific showing rapid growth driven by rising awareness and urbanization.

• By Indication: Asthma management remains the primary segment, with allergic rhinitis constituting a smaller but growing market segment due to increased environmental allergens.

• By Formulation: Fluticasone inhalers (Metered Dose Inhalers and Diskus dry powder inhalers) dominate, with the latter gaining traction due to ease of use and patient preference.

Competitive Landscape

Major competitors include AstraZeneca’s Symbicort (combination corticosteroid and LABA), Teva’s Fluticasone propionate nasal spray, and generic alternatives post-patent expiration. Notably, GSK’s focus on expanding formulation options and delivering personalized medicine strategies maintains Flovent’s market robustness.

Pricing and Reimbursement Dynamics

Pricing strategies for Flovent are increasingly influenced by regional healthcare policies and insurance schemes. In mature markets like the US and Europe, reimbursement facilitates widespread access, while emerging markets are witnessing price sensitivity adjustments. GSK's patient assistance programs further enhance accessibility.

Regulatory Environment

Regulatory agencies like the FDA and EMA continue to enforce stringent safety and efficacy standards, with recent approvals emphasizing inhaler device innovation and pediatric use subsets. This regulatory rigor influences market entry strategies and product development.

Future Market Projections

Growth Drivers

• Rising Prevalence of Asthma: The WHO estimates approximately 262 million people with asthma globally, spanning all age groups, boosting demand for effective inhaled corticosteroids like Flovent.

• Innovative Delivery Technologies: Advancements in inhaler devices — including smart inhalers with digital tracking — are expected to improve adherence and clinical outcomes.

• Expanded Indications: Ongoing research into Fluticasone’s role in nasal polyps and COPD may unlock additional revenue streams.

• Personalized Medicine: Pharmacogenetic insights will allow targeted therapy, potentially expanding Flovent’s use in specific subpopulations.

Challenges Impacting Growth

• Generic Competition: Patent expirations can lead to increased generic options, exerting downward pressure on prices and market share.

• Environmental Regulations: Inhalers involving hydrofluorocarbon (HFC) propellants face regulatory phase-outs, prompting shifts to environmentally friendly alternatives.

• Patient Adherence: Despite technological improvements, adherence remains an issue, especially among pediatric and elderly populations.

Forecasted Revenue Trajectory

Analysts project that Flovent’s global sales will grow at a CAGR of 3-4% through 2030, reaching approximately $2.5 billion annually, factoring in market expansion, product innovation, and demographic trends.

Key Takeaways

• Clinical Innovation: Ongoing trials focus on enhancing Fluticasone’s delivery, safety, and efficacy, including combination therapies and novel formulations. GSK's investment in research underpins future therapeutic advancements.

• Market Stability and Expansion: Despite patent cliffs, Flovent retains its market position through formulation diversity, device innovation, and expanding indications. Asia-Pacific and emerging markets offer significant growth opportunities.

• Regulatory and Environmental Factors: Evolving regulations and environmental concerns necessitate adaptation, including environmentally friendly inhalers and compliance with new standards.

• Competitive Dynamics: GSK’s strategic differentiation through technological innovation, patient-centric approaches, and broadening indications will sustain Flovent’s competitive edge.

• Future Outlook: The inhaled corticosteroid market is expected to grow steadily, with Flovent poised to benefit from technological advancements, increasing disease prevalence, and personalized medicine initiatives.

Conclusion

Flovent remains a vital therapy in respiratory medicine, with a steady pipeline of clinical research aimed at optimizing patient outcomes and expanding its applications. The evolving market landscape, shaped by innovation, regulation, and demographic trends, suggests sustained growth. Stakeholders must monitor ongoing clinical developments, competitive positioning, and regulatory changes to navigate the future landscape effectively.

---

FAQs

1. What are the main clinical advantages of Flovent over other inhaled corticosteroids?
Flovent (fluticasone propionate) is renowned for its high potency, targeted pulmonary delivery, and minimal systemic absorption, leading to effective asthma control with fewer systemic side effects.

2. How might upcoming clinical trial results impact Flovent’s market positioning?
Positive trial outcomes demonstrating enhanced efficacy, safety, or new indications could reinforce Flovent’s market dominance, potentially leading to expanded labeling and increased prescribing.

3. What are the significant regulatory challenges facing Flovent’s future?
Environmental regulations may phase out HFC-based inhalers, necessitating development of greener formulations. Additionally, generic competition post-patent expiration could impact pricing and market share.

4. How is technological innovation influencing Flovent’s market?
Smart inhalers and digital adherence tools linked to Fluticasone formulations improve patient compliance, optimize dosing, and provide real-time data, making the medication more attractive to clinicians and patients.

5. What opportunities exist for Flovent in emerging markets?
Increasing asthma prevalence, expanding healthcare infrastructure, and rising awareness present growth prospects. GSK’s local partnerships and affordable formulations will be key drivers.

---

Sources

[1] Fortune Business Insights, “Inhaled Corticosteroids Market Size & Share Analysis — Growth Trends & Forecasts 2022-2027”.
[2] ClinicalTrials.gov, Database of ongoing and completed clinical trials related to Flovent and fluticasone formulations.
[3] World Health Organization, “Asthma Fact Sheet,” 2022.
[4] GSK Annual Reports and Official Communications.