CLINICAL TRIALS PROFILE FOR FLOVENT DISKUS 50

All Clinical Trials for Flovent Diskus 50

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

Clinical Trial Conditions for Flovent Diskus 50

Condition Name

Condition Name for Flovent Diskus 50
Intervention	Trials
Asthma	16
Bioequivalence	2
Chronic Obstructive Pulmonary Disease	1
Mild Asthma	1

Condition MeSH

Condition MeSH for Flovent Diskus 50
Intervention	Trials
Asthma	15
Respiratory Aspiration	3
Blister	3
Hypersensitivity	1

Clinical Trial Locations for Flovent Diskus 50

Trials by Country

Trials by Country for Flovent Diskus 50
Location	Trials
United States	199
Canada	13
Brazil	8
Greece	4
Argentina	4

Trials by US State

Trials by US State for Flovent Diskus 50
Location	Trials
Florida	10
Texas	7
Pennsylvania	7
Ohio	7
Missouri	7

Clinical Trial Progress for Flovent Diskus 50

Clinical Trial Phase

Clinical Trial Phase for Flovent Diskus 50
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Flovent Diskus 50
Clinical Trial Phase	Trials
Completed	14
Recruiting	2
Terminated	1

Clinical Trial Sponsors for Flovent Diskus 50

Sponsor Name

Sponsor Name for Flovent Diskus 50
Sponsor	Trials
Teva Branded Pharmaceutical Products R&D, Inc.	6
Teva Branded Pharmaceutical Products, R&D Inc.	4
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for Flovent Diskus 50
Sponsor	Trials
Other	29
Industry	24
NIH	2

FLOVENT DISKUS 50: Clinical Trials, Market Analysis, and Projections

Introduction

FLOVENT DISKUS 50, an inhalation powder containing fluticasone propionate, has been a cornerstone in the management of asthma for over two decades. This article delves into the clinical trials, market analysis, and future projections for this medication, especially in light of recent changes in its availability and pricing.

Clinical Trials Overview

Efficacy and Safety

Clinical trials have consistently demonstrated the efficacy and safety of FLOVENT DISKUS. In a series of 12-week trials involving adolescents and adults, FLOVENT DISKUS showed significant improvements in pulmonary function, including forced expiratory volume in 1 second (FEV1) and morning peak expiratory flow (PEF), compared to placebo. These improvements were maintained for up to 1 year or more in some studies[1][4].

Patient Population

The trials included a diverse patient population, including children as young as 4 years old and adults with varying degrees of asthma severity. For instance, in pediatric trials, 592 subjects aged 4 to 11 years were treated with FLOVENT DISKUS, showing its safety and efficacy in this age group[4].

Dosage and Delivery

FLOVENT DISKUS is available in several doses (50 mcg, 100 mcg, and 250 mcg) and is delivered through a dry powder inhaler. The actual amount of drug delivered to the lung can vary based on patient factors such as inspiratory flow profile[1].

Adverse Reactions and Safety Profile

Common Adverse Reactions

Clinical trials have identified several common adverse reactions associated with FLOVENT DISKUS, including upper respiratory tract infections, pharyngitis, upper respiratory inflammation, and headaches. However, these reactions were generally mild and did not lead to significant discontinuation rates[4].

Serious Adverse Events

Serious adverse events were collected during and after the trials, but there was no significant increase in such events compared to placebo. The safety profile of FLOVENT DISKUS has been well-established, making it a reliable option for long-term asthma management[1][4].

Market Analysis

Discontinuation of Branded Version

As of January 1, 2024, GlaxoSmithKline (GSK) has discontinued the branded version of FLOVENT DISKUS in the United States, replacing it with an authorized generic version. This move is part of GSK's strategy to provide lower-cost alternatives to patients[2].

Pricing and Insurance Coverage

The authorized generic version of FLOVENT DISKUS is priced lower than the branded version, for example, the wholesale acquisition cost of the authorized generic Flovent HFA is $177.99, compared to $273.83 for the branded version. However, insurance coverage for the generic version has been complicated, with some pharmacy benefit managers giving preferential placement to other branded inhalers like Pulmicort[2].

Market Impact

The transition to an authorized generic version is expected to have a significant impact on the market. Doctors and advocacy groups are urging patients to prepare for this change to avoid disruptions in their medication supply. The move also highlights the complexities of drug pricing and insurance coverage in the U.S. healthcare system[2].

Projections and Future Outlook

Cost Savings

The introduction of the authorized generic version of FLOVENT DISKUS is expected to bring cost savings to patients and healthcare systems. Lower pricing could increase accessibility and adherence to treatment, particularly for patients who were previously deterred by high costs[2].

Market Share

Despite the discontinuation of the branded version, FLOVENT DISKUS is likely to maintain a significant market share due to its established reputation and efficacy. However, the preferential placement of other branded inhalers by some pharmacy benefit managers could affect its market position[2].

Regulatory Environment

Changes in regulatory policies, such as the elimination of the Medicaid rebate cap, are expected to influence the pricing and availability of asthma medications. These changes could further impact the market dynamics and patient access to essential medications like FLOVENT DISKUS[2].

Environmental Considerations

Propellants and Sustainability

The inhaler industry, including dry powder inhalers like FLOVENT DISKUS, is under scrutiny for its environmental impact, particularly regarding the use of hydrofluorocarbons (HFCs) as propellants. Research is ongoing to find more sustainable alternatives, such as hydrofluoroolefins (HFOs), which could become more prevalent in the future[5].

Key Takeaways

• FLOVENT DISKUS has a strong clinical trial record demonstrating its efficacy and safety in managing asthma.
• The transition to an authorized generic version is expected to reduce costs and increase accessibility.
• Market dynamics, including insurance coverage and regulatory changes, will continue to shape the availability and pricing of FLOVENT DISKUS.
• Environmental considerations are becoming increasingly important in the development and use of inhaler medications.

FAQs

What is FLOVENT DISKUS used for?

FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. It is also used for patients requiring oral corticosteroid therapy for asthma[1].

Why is the branded version of FLOVENT DISKUS being discontinued?

The branded version of FLOVENT DISKUS is being discontinued by GSK to introduce an authorized generic version, which is expected to provide a lower-cost alternative to patients[2].

How does the authorized generic version of FLOVENT DISKUS differ from the branded version?

The authorized generic version of FLOVENT DISKUS is chemically identical to the branded version but is priced lower. However, it may face challenges in terms of insurance coverage[2].

What are the common adverse reactions associated with FLOVENT DISKUS?

Common adverse reactions include upper respiratory tract infections, pharyngitis, upper respiratory inflammation, and headaches. These reactions are generally mild and do not often lead to discontinuation[4].

How will the transition to an authorized generic version affect patients?

Patients are advised to prepare for the transition to ensure continuous access to their medication. The lower cost of the authorized generic version could improve adherence to treatment, but patients should check with their insurance providers regarding coverage[2].

What are the environmental implications of using FLOVENT DISKUS?

FLOVENT DISKUS, as a dry powder inhaler, does not contain HFCs, which are a concern for environmental sustainability. However, the broader inhaler industry is moving towards more sustainable propellants, which may influence future formulations[5].

Sources

1. FLOVENT® DISKUS® 50 mcg - accessdata.fda.gov
2. Asthma inhaler Flovent to be replaced by generic version in January - CBS News
3. FDA approves US label update on ICS/LABA combinations in asthma based on review of safety data - GSK
4. FLOVENT DISKUS (fluticasone propionate inhalation powder) - GSK
5. Market Characterization of the U.S. Metered Dose Inhaler Industry - EPA

Last updated: 2025-01-01