Last Updated: May 14, 2026

CLINICAL TRIALS PROFILE FOR FLOVENT DISKUS 250


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All Clinical Trials for FLOVENT DISKUS 250

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)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FLOVENT DISKUS 250

Condition Name

Condition Name for FLOVENT DISKUS 250
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 250
Intervention Trials
Asthma 15
Respiratory Aspiration 3
Blister 3
Lung Diseases 1
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Clinical Trial Locations for FLOVENT DISKUS 250

Trials by Country

Trials by Country for FLOVENT DISKUS 250
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 250
Location Trials
Florida 10
California 7
Colorado 7
Texas 7
Pennsylvania 7
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Clinical Trial Progress for FLOVENT DISKUS 250

Clinical Trial Phase

Clinical Trial Phase for FLOVENT DISKUS 250
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 250
Clinical Trial Phase Trials
Completed 14
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for FLOVENT DISKUS 250

Sponsor Name

Sponsor Name for FLOVENT DISKUS 250
Sponsor Trials
Teva Branded Pharmaceutical Products R&D, Inc. 6
Teva Branded Pharmaceutical Products, R&D Inc. 4
GlaxoSmithKline 4
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Sponsor Type

Sponsor Type for FLOVENT DISKUS 250
Sponsor Trials
Other 29
Industry 24
NIH 2
[disabled in preview] 0
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Clinical Trials Update, Market Analysis, and Projection for FLOVENT DISKUS 250

Last updated: February 20, 2026

What is the current status of clinical trials involving FLOVENT DISKUS 250?

FLOVENT DISKUS 250 contains fluticasone propionate, a corticosteroid used to prevent asthma symptoms. It is approved for long-term treatment of asthma and COPD. As of the latest data, there are no ongoing or newly registered clinical trials specifically focused on FLOVENT DISKUS 250 or its formulations. The last major trial involving FLOVENT occurred over the past five years primarily for indications such as persistent asthma and COPD management.

Clinical trials involving fluticasone formulations have generally centered on efficacy, safety, and comparison with other inhaled corticosteroids (ICS). The most recent Phase III studies, completed by GlaxoSmithKline (GSK), evaluated higher dose regimens for enhanced control in severe asthma. No significant new investigations targeting FLOVENT DISKUS 250 specifically have been initiated or completed in the past 24 months.

What are the key findings from existing clinical trials involving FLOVENT and similar formulations?

Trial Focus Population Duration Outcomes Key Result
Efficacy in asthma Adults, adolescents 12-52 weeks Reduction in exacerbations, improvement in lung function FLOVENT compounds reduce airway inflammation, improve FEV1 scores
Safety profile Chronic use patients Up to 52 weeks Incidence of adverse effects No significant systemic corticosteroid side effects at prescribed doses
Comparison with other ICS Adults 12 weeks Symptom control, lung function FLOVENT performs comparably with beclomethasone, mometasone

These trials confirm FLOVENT’s well-established efficacy for its approved indications. The safety profile aligns with corticosteroids' known risk profile, including oral thrush and hoarseness, with low systemic absorption at prescribed doses.

How does market presence and competitive landscape influence FLOVENT DISKUS 250?

Market Share and Sales Data

Since its approval, FLOVENT DISKUS has maintained a significant share in the inhaled corticosteroid market, particularly within the asthma and COPD segments. In 2022, the global inhaled corticosteroids market was valued at approximately USD 7.9 billion, projected to grow at a CAGR of 4.2% through 2030.

GSK's market share in this segment stands at approximately 35%, with FLOVENT DISKUS being a primary product. The product's revenue position has remained stable, with Europe and North America accounting for over 60% of sales.

Competitive Portfolio

Major competitors include:

  • AstraZeneca’s Symbicort (budesonide/formoterol)
  • AstraZeneca’s Pulmicort (budesonide)
  • Teva’s Qvar (beclomethasone dipropionate)
  • Novartis’s Ultibro (indacaterol/glycopyrronium, primarily COPD)

FLOVENT remains competitive on efficacy and safety but faces price pressure and formulary access restrictions.

Regulatory Factors

Regulatory agencies have maintained approval pathways for existing doses, with some push toward combination inhalers. No recent regulatory changes have directly affected FLOVENT DISKUS 250.

What are the projections for FLOVENT DISKUS 250’s market over the next five years?

The inhaled corticosteroid market is expected to grow at 4-5% annually. Key drivers include:

  • Increasing prevalence of asthma, currently affecting 300 million globally
  • Rising COPD cases, now estimated at 200 million worldwide
  • Expanded use of inhaled corticosteroids in combination therapies

FLOVENT DISKUS 250, with its established efficacy profile, is forecasted to retain a substantial market share, especially in mature markets like North America and Europe, where adherence to treatment guidelines remains high.

Assuming GSK maintains current production levels and navigates market access successfully, revenues for FLOVENT DISKUS could grow by approximately 3-4% annually, reaching USD 1.2 billion by 2028. Competition from generic inhalers may pressure pricing, affecting margins but not overall sales volume significantly.

What are the key regulatory and market risks?

  • Potential for new combination therapies to replace monotherapy
  • Patent expirations affecting pricing strategies
  • Regulatory shifts favoring combination inhalers over monotherapy
  • Generic entry post-patent expiration, likely by 2029

How might upcoming innovations influence FLOVENT DISKUS 250?

Future developments include:

  • Biosimilars or generics for fluticasone propionate
  • Novel inhaler devices with enhanced delivery efficacy
  • Combination inhalers integrating anti-inflammatory and bronchodilator agents

While these innovations could limit market share growth, FLOVENT’s established presence and clinician familiarity serve as barriers to immediate displacement.

Key Takeaways

  • No current clinical trials focus specifically on FLOVENT DISKUS 250.
  • Its efficacy and safety profile remains validated by historical data.
  • Market share is stable, supported by a broad approved indication spectrum.
  • Growth projections indicate a steady CAGR of approximately 3-4% over the next five years.
  • Risks include patent expiration, increased competition from generics, and emerging combination therapies.

FAQs

1. When is the patent for FLOVENT DISKUS 250 expected to expire?
Patent expiry is anticipated around 2029, after which generic versions may enter the market.

2. Are there any new formulations or delivery devices under development for FLOVENT?
GSK is exploring improved inhaler devices, but no new formulations specifically targeting FLOVENT DISKUS 250 have been announced.

3. How does FLOVENT DISKUS compare to other inhaled corticosteroids?
It offers comparable efficacy and a similar safety profile to alternatives like Pulmicort and Qvar. Differentiation relies on delivery device preference and clinician familiarity.

4. What are the main barriers to market growth for FLOVENT DISKUS?
Generic competition after patent expiration and the penetration of combination inhalers targeting asthma and COPD.

5. What is the outlook for FLOVENT DISKUS in COPD treatment?
While primarily indicated for asthma, higher-dose formulations, including 250 mcg, are used off-label for COPD, with market potential linked to COPD treatment expansion and guideline updates.


Sources

  1. GSK. (2022). FLOVENT DISKUS prescribing information.
  2. Statista. (2023). Global inhaled corticosteroids market size and forecast.
  3. Research and Markets. (2022). Inhaled corticosteroids market analysis.
  4. FDA. (2021). Patents, exclusivity, and regulatory information for FLOVENT.
  5. World Health Organization. (2022). Asthma and COPD prevalence data.

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