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Last Updated: February 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
>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
Respiratory Aspiration 3
Blister 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
Colorado 7
Texas 7
Pennsylvania 7
Ohio 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
[disabled in preview] 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
[disabled in preview] 2
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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
Teva Branded Pharmaceutical Products, R&D Inc. 4
GlaxoSmithKline 4
[disabled in preview] 6
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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, Market Analysis, and Projections for FLOVENT DISKUS 100 mcg

Introduction

FLOVENT DISKUS, containing the active ingredient fluticasone propionate, is a widely used inhaled corticosteroid (ICS) for the maintenance treatment of asthma in patients aged 4 years and older. Here, we will delve into recent clinical trials, market analysis, and projections for FLOVENT DISKUS 100 mcg.

Clinical Trials Overview

Recent Studies

Several clinical trials have been conducted to evaluate the efficacy and safety of FLOVENT DISKUS. A notable study involved a 12-week clinical trial where FLOVENT DISKUS was administered in doses of 50 to 500 mcg twice daily to adults and adolescents receiving inhaled corticosteroids. This trial highlighted the drug's efficacy in managing asthma symptoms while also detailing its adverse event profile[1].

Another clinical trial aimed to examine the therapeutic equivalence between Fluticasone propionate 100 mcg/blister oral inhalation powder (Respirent Pharmaceuticals) and FLOVENT DISKUS 100 mcg/blister oral inhalation powder. This randomized, multiple-dose, placebo-controlled trial involved 451 participants and included a 2-week run-in period followed by a 4-week treatment period[4].

Adverse Events

Clinical trials have consistently shown that FLOVENT DISKUS is generally well-tolerated, with common adverse events including upper respiratory tract infections, throat irritation, sinusitis, and oral candidiasis. These events were more frequent in the treatment groups compared to the placebo group but were not severe enough to cause significant discontinuation rates (less than 2% of subjects discontinued due to adverse reactions)[1][5].

Pediatric Trials

In pediatric trials involving subjects aged 4 to 11 years, FLOVENT DISKUS was administered at doses of 50 or 100 mcg twice daily. These trials did not reveal any clinically relevant differences in the pattern or severity of adverse events compared to adults[1].

Market Analysis

Market Share and Competitors

FLOVENT DISKUS competes in the ICS market with other fluticasone propionate formulations such as FLOVENT HFA and newer multidose dry powder inhalers (MDPI) like Aermony RespiClick. A pharmacoeconomic review in Canada compared the costs of these formulations, showing that FLOVENT DISKUS had a lower annual cost compared to FLOVENT HFA but was more expensive than FLOVENT MDPI (Aermony RespiClick)[2].

Cost Comparison

The cost analysis indicated that FLOVENT DISKUS had a unit cost of $0.7588, resulting in a monthly cost of $54.59 and an annual cost of $655.12. In contrast, FLOVENT MDPI (Aermony RespiClick) had a lower annual cost of $547.61, representing a cost reduction of 16.41% compared to FLOVENT DISKUS[2].

Market Trends

The ICS market is evolving with the introduction of new formulations and devices. The removal of boxed warnings from ICS/LABA combination products, such as BREO ELLIPTA and ADVAIR DISKUS, has also influenced market dynamics, potentially increasing the appeal of these combination therapies over standalone ICS like FLOVENT DISKUS[3].

Projections

Market Growth

The asthma treatment market is expected to grow due to increasing prevalence and the need for effective management options. However, FLOVENT DISKUS may face competition from newer, more cost-effective alternatives and combination therapies.

Patient Preferences

Patient preferences for inhaler devices and formulations can significantly impact market share. The convenience and ease of use of MDPIs like Aermony RespiClick may attract patients who prefer simpler inhalation techniques.

Regulatory Environment

Regulatory updates, such as the removal of boxed warnings from ICS/LABA combinations, can influence prescribing practices and patient safety profiles, potentially affecting the market share of FLOVENT DISKUS.

Key Takeaways

  • Clinical Efficacy: FLOVENT DISKUS 100 mcg has been shown to be effective in managing asthma symptoms in both adults and children.
  • Adverse Events: Common adverse events include upper respiratory tract infections, throat irritation, and oral candidiasis, but these are generally well-tolerated.
  • Market Competition: FLOVENT DISKUS faces competition from other fluticasone propionate formulations and newer MDPIs, which may offer cost advantages.
  • Cost Analysis: FLOVENT DISKUS is more expensive than some newer formulations but remains a viable option due to its established efficacy and safety profile.
  • Market Trends: The market is shifting towards combination therapies and more convenient inhaler devices, which could impact the future market share of FLOVENT DISKUS.

FAQs

What is FLOVENT DISKUS used for?

FLOVENT DISKUS is used for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older[5].

What are the common adverse events associated with FLOVENT DISKUS?

Common adverse events include upper respiratory tract infections, throat irritation, sinusitis, and oral candidiasis[1][5].

How does FLOVENT DISKUS compare to other fluticasone propionate formulations in terms of cost?

FLOVENT DISKUS is more expensive than FLOVENT MDPI (Aermony RespiClick) but less expensive than FLOVENT HFA[2].

Are there any recent clinical trials evaluating FLOVENT DISKUS?

Yes, recent trials have evaluated the therapeutic equivalence of FLOVENT DISKUS with other fluticasone propionate formulations and assessed its safety and efficacy in various patient populations[1][4].

What are the potential market trends affecting FLOVENT DISKUS?

The market is influenced by the introduction of new formulations, combination therapies, and changes in regulatory environments, which may impact patient preferences and prescribing practices[2][3].

Sources

  1. FDA Label: FLOVENT DISKUS (fluticasone propionate inhalation powder), for oral inhalation use[1].
  2. CADTH Pharmacoeconomic Review: CDR Pharmacoeconomic Review Report for Aermony RespiClick[2].
  3. GSK Press Release: FDA approves US label update on ICS/LABA combinations in asthma[3].
  4. ClinicalTrials.gov: A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals[4].
  5. Drugs.com: Flovent Diskus: Package Insert / Prescribing Information[5].

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