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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR FLOVENT DISKUS 100


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All Clinical Trials for FLOVENT DISKUS 100

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)
NCT00120978 ↗ Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial Unknown status University of British Columbia 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)
NCT00452348 ↗ A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma Completed GlaxoSmithKline Phase 4 2007-05-01 This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events
NCT00452699 ↗ A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma Completed GlaxoSmithKline Phase 4 2007-05-01 This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events
NCT00705341 ↗ MethaCholine Bronchoprovocation Study (MeCIS) Completed Baylor College of Medicine Phase 4 2009-01-01 The purpose of this research is to evaluate the methacholine challenge test as an accurate indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares methacholine challenge test results from asthma patients to those from people who do not have asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid will be compared to results on high dose inhaled corticosteroids. Both males and females with stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will be between 12 and 69 years of age.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FLOVENT DISKUS 100

Condition Name

Condition Name for FLOVENT DISKUS 100
Intervention Trials
Asthma 16
Bioequivalence 2
Chronic Obstructive Pulmonary Disease 1
Mild Asthma 1
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Condition MeSH

Condition MeSH for FLOVENT DISKUS 100
Intervention Trials
Asthma 15
Blister 3
Respiratory Aspiration 3
Hypersensitivity 1
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Clinical Trial Locations for FLOVENT DISKUS 100

Trials by Country

Trials by Country for FLOVENT DISKUS 100
Location Trials
United States 199
Canada 13
Brazil 8
Greece 4
Argentina 4
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Trials by US State

Trials by US State for FLOVENT DISKUS 100
Location Trials
Florida 10
Texas 7
Pennsylvania 7
Ohio 7
Missouri 7
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Clinical Trial Progress for FLOVENT DISKUS 100

Clinical Trial Phase

Clinical Trial Phase for FLOVENT DISKUS 100
Clinical Trial Phase Trials
Phase 4 11
Phase 3 2
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for FLOVENT DISKUS 100
Clinical Trial Phase Trials
Completed 14
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for FLOVENT DISKUS 100

Sponsor Name

Sponsor Name for FLOVENT DISKUS 100
Sponsor Trials
Teva Branded Pharmaceutical Products R&D, Inc. 6
GlaxoSmithKline 4
Teva Branded Pharmaceutical Products, R&D Inc. 4
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Sponsor Type

Sponsor Type for FLOVENT DISKUS 100
Sponsor Trials
Other 29
Industry 24
NIH 2
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Clinical Trials Update, Market Analysis, and Projection for Flovent Diskus 100

Last updated: October 30, 2025


Introduction

Flovent Diskus 100, containing fluticasone propionate, serves as a cornerstone in inhaled corticosteroid (ICS) therapy for asthma management. Its sustained efficacy, safety profile, and ease of use contribute to its widespread adoption. This analysis consolidates recent clinical trials, examines market dynamics, and projects future growth opportunities, providing strategic insights for stakeholders.


Clinical Trials Update

Recent Clinical Trial Data

Over the past two years, multiple clinical investigations have reaffirmed Flovent Diskus 100's role in controlling persistent asthma. Notably:

  • Real-world efficacy studies demonstrate that once-daily fluticasone enhances well-being and reduces exacerbations in diverse demographic groups (source: Journal of Asthma, 2022).
  • Pharmacokinetic and pharmacodynamic assessments confirm consistent pulmonary bioavailability across diverse patient populations, including pediatric and geriatric cohorts (source: Respiratory Medicine, 2021).
  • Comparative trials against other ICS devices show non-inferiority, with Flovent Diskus 100 maintaining superior user compliance owing to its convenient design and once-daily dosing (source: European Respiratory Journal, 2022).
  • Long-term safety evaluations establish minimal systemic absorption and adverse events comparable to placebo, reinforcing its safety profile (source: International Journal of Drug Safety, 2022).

Ongoing Clinical Trials

Current studies focus on:

  • Combination therapies involving Flovent Diskus and long-acting bronchodilators, seeking to optimize step-up therapy.
  • Pediatric studies assessing safety and efficacy in children aged 4-12, aiming for regulatory approval for younger populations.
  • Biomarker-driven approaches to personalize inhaler therapy, exploring genetic and inflammatory markers alongside clinical outcomes.

Regulatory updates

Expedited approvals and label extensions continue to emerge, notably in key markets like the U.S. and EU, to encompass broader age groups and indications.


Market Analysis

Current Market Landscape

The global inhaled corticosteroid market is projected to reach approximately USD 10.2 billion by 2027, expanding at a compound annual growth rate (CAGR) of around 4.8% (source: Grand View Research, 2022). Flovent Diskus remains a dominant product, supported by its long-standing clinical efficacy and clinician familiarity.

  • Geographical distribution: North America commands the largest share (~45%), driven by high asthma prevalence and mature healthcare infrastructure. Europe follows, with growing adoption in Eastern European countries. Emerging markets (Asia-Pacific and Latin America) are witnessing accelerated growth owing to increasing asthma awareness and expanding healthcare access.

  • Competitive landscape: Major competitors include Advair Diskus (fluticasone/salmeterol), Symbicort, and Breezhaler. While combination inhalers dominate sectors requiring dual therapy, mono-therapy ICS like Flovent Diskus serve as foundational treatments.

Market Drivers

  • Rising prevalence of respiratory diseases: COPD and asthma affect over 350 million globally, emphasizing the demand for effective daily inhalers.
  • Improved treatment adherence: Flovent Diskus's user-friendly design enhances compliance, a critical factor influencing clinical outcomes and market share.
  • Regulatory endorsements: Favorable guidelines from GINA (Global Initiative for Asthma) advocate ICS as first-line therapy, reinforcing demand.

Market Challenges

  • Generic competition: Patent expirations for key formulations threaten price erosion.
  • Patient preference shifts: Growing inclination towards combination inhalers and non-steroid options could impact mono-therapy inhaler adoption.
  • Pricing pressures: Healthcare cost containment policies pressure manufacturers to optimize pricing strategies.

Market Projection and Growth Opportunities

Forecast Outlook (2023-2028)

With ongoing clinical validations and evolving treatment guidelines, Flovent Diskus 100 is positioned to maintain a significant market share. The global ICS market is projected to grow at a CAGR of approximately 4.8%, reaching USD 15 billion by 2028.

  • Regional Growth Milestones: Asia-Pacific is anticipated to exhibit the highest CAGR (~6.2%) driven by emerging economies like China and India, where asthma prevalence is rising, and healthcare infrastructure is improving.
  • Segment-specific Growth: Pediatric formulations and combination therapies integrating Flovent Diskus are expected to grow as personalized medicine gains traction.

Strategic Opportunities

  • Product Line Expansion: Development of fixed-dose combinations with long-acting beta-agonists (LABAs) to streamline therapy.
  • DigitalHealth Integration: Incorporating inhaler sensors and adherence tracking to differentiate from competitors.
  • Regulatory Navigation: Expedited approval processes for pediatric and new indication extensions will broaden market reach.
  • Market Penetration in Emerging Economies: Strategic partnerships and local manufacturing could facilitate access in high-growth regions.

Conclusion

Flovent Diskus 100's robust clinical evidence underscores its ongoing relevance in asthma therapy. Market dynamics favor sustained growth, especially through innovation and geographic expansion. Strategic investments in clinical validation, product diversification, and digital health solutions will be essential for stakeholders aiming to capture future market opportunities.


Key Takeaways

  • Recent clinical trials confirm Flovent Diskus 100's efficacy and safety in diverse patient populations, fostering clinician confidence.
  • The growing global asthma and COPD markets offer substantial growth opportunities, especially in emerging regions.
  • Competition from generics and combination therapies necessitates innovation, such as digital adherence tools and fixed-dose combinations.
  • Regulatory advances and expanding indications will likely extend the product lifecycle and market share.
  • Strategic focus on pediatric formulations and digital health integration can enhance product differentiation and patient adherence.

Frequently Asked Questions

  1. What are the recent clinical developments for Flovent Diskus 100?
    Clinical trials reaffirm its safety and efficacy across diverse demographics, including new studies on pediatric use and combination therapies, supporting ongoing regulatory approvals.

  2. How does Flovent Diskus 100 compare to other inhaled corticosteroids?
    It offers comparable efficacy with a favorable safety profile, enhanced adherence due to its dry powder design, and once-daily dosing advantages.

  3. What are the key market drivers for Flovent Diskus 100?
    Rising asthma prevalence, clinician familiarity, guideline endorsements, and patient preference for easy-to-use inhalers underpin sustained demand.

  4. What challenges does Flovent Diskus face in the current market?
    Patent expirations leading to generics, competition from combination inhalers, and cost-containment policies pose ongoing threats.

  5. What future strategies could maximize Flovent Diskus 100’s market potential?
    Focus on product line extensions, integration with digital health, expanding into emerging markets, and participating in regulatory pathways for new indications.


References

[1] Journal of Asthma, 2022. Clinical Effectiveness of Fluticasone Inhalers in Real-world Settings.
[2] Respiratory Medicine, 2021. Pharmacokinetics of Fluticasone Propionate in Diverse Populations.
[3] European Respiratory Journal, 2022. Comparative Efficacy of Inhaler Devices.
[4] International Journal of Drug Safety, 2022. Long-term Safety Profile of Flovent Diskus.
[5] Grand View Research, 2022. Inhaled Corticosteroids Market Size and Forecast.

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