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)
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)
NCT00123656 ↗	Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis	Completed	American Society for Gastrointestinal Endoscopy	Phase 2	2004-08-01	Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.
NCT00123656 ↗	Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis	Completed	University of Utah	Phase 2	2004-08-01	Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.
NCT00214019 ↗	The Effect of Salmeterol on Eosinophil (EOS) Function	Completed	GlaxoSmithKline	N/A	2003-11-01	This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.

Clinical Trial Conditions for Flovent

Condition Name

Condition Name for Flovent
Intervention	Trials
Asthma	22
Eosinophilic Esophagitis	4
Bioequivalence	2
Tobacco Abuse Smoke	1

Condition MeSH

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

Flovent: Clinical Trials, Market Analysis, and Projections

Introduction to Flovent

Flovent, also known as fluticasone propionate, is a widely used inhaled corticosteroid (ICS) for the management of asthma and other respiratory conditions. It is manufactured by GlaxoSmithKline (GSK) and has been a staple in asthma treatment for many years.

Clinical Trials and Efficacy

Historical Clinical Trials

Clinical trials have consistently shown that Flovent is effective in managing asthma symptoms. In trials, Flovent has demonstrated its ability to reduce inflammation in the airways, thereby decreasing the frequency and severity of asthma attacks. For example, clinical trials involving over 800 subjects showed that Flovent reduced symptoms of asthma and improved lung function compared to placebo[4].

Recent Developments and Challenges

However, recent studies and trials have highlighted some challenges associated with Flovent. For instance, the ACTIV-6 trial, which tested various medications for COVID-19, included an arm using fluticasone furoate (a similar compound to fluticasone propionate) and found no symptomatic or clinical benefit in reducing COVID-19 symptoms. Additionally, there was evidence of increased acute care needs in the fluticasone furoate arm[1].

Market Analysis

Discontinuation of Branded Flovent HFA

In 2024, GSK decided to stop manufacturing the branded version of Flovent HFA, citing regulatory changes and financial disincentives. This decision was met with criticism from lawmakers, who argued that GSK was attempting to evade Medicaid payments and maintain high prices. The branded version was replaced by an authorized generic version of fluticasone propionate, which, despite being cheaper in theory, has been found to be more expensive in practice in some cases[2][5].

Impact on Patients

The discontinuation of the branded Flovent HFA has had significant implications for patients. Data from over 3 million people who had been using Flovent showed a 17.5% increase in asthma-related hospitalizations in the three months after the discontinuation, and a 24.1% increase in the following three to six months. This increase in hospitalizations highlights the critical need for stable and affordable access to this medication[2].

Regulatory and Financial Aspects

The decision to switch to an authorized generic has been scrutinized by regulators and lawmakers. Senators such as Elizabeth Warren and Maggie Hassan have accused GSK of using this switch as a way to sidestep price caps and Medicaid rebates, which were intended to make the medication more affordable for patients. GSK has maintained that the decision was part of its long-term strategy and that the generic version is just as effective as the branded one[5].

Projections and Future Outlook

Market Trends

The asthma medication market is expected to continue growing, driven by the increasing prevalence of asthma and the need for effective treatments. However, the recent controversy surrounding Flovent's discontinuation and the higher costs of the generic version may impact market dynamics. Patients and healthcare providers may seek alternative treatments, potentially affecting GSK's market share.

Alternative Treatments

GSK is also developing new treatments for severe asthma, such as depemokimab, which has shown promising results in phase III trials. Depemokimab has the potential to be the first ultra-long-acting biologic with a six-month dosing schedule, which could simplify treatment for millions of patients with severe asthma[3].

Regulatory Environment

The regulatory environment is likely to remain a significant factor in the market for asthma medications. Changes in laws and regulations, such as those introduced by the American Rescue Plan Act, can influence pricing strategies and access to medications. Manufacturers will need to navigate these changes carefully to ensure that their products remain accessible and affordable for patients.

Safety and Adverse Reactions

Common Adverse Reactions

Clinical trials have identified several common adverse reactions associated with Flovent, including upper respiratory tract infections, throat irritation, and candidiasis of the mouth and throat. These reactions are generally mild and do not often lead to discontinuation of the medication[4].

Serious Adverse Reactions

More serious adverse reactions, such as growth effects, glaucoma, and cataracts, have also been reported, although these are less common. It is crucial for patients to be monitored by healthcare providers to manage these risks effectively[4].

Key Takeaways

• Efficacy: Flovent has been shown to be effective in managing asthma symptoms in clinical trials.
• Market Changes: The discontinuation of the branded Flovent HFA and the introduction of an authorized generic version have led to increased costs and hospitalizations for some patients.
• Regulatory Impact: Regulatory changes and financial disincentives have influenced GSK's decision-making, affecting patient access to affordable medications.
• Future Outlook: The market is expected to grow, but GSK's market share may be impacted by the controversy surrounding Flovent. New treatments like depemokimab are on the horizon.
• Safety: Flovent is generally safe, but patients should be aware of potential adverse reactions and be monitored by healthcare providers.

FAQs

What is Flovent used for?

Flovent, or fluticasone propionate, is an inhaled corticosteroid used primarily for the management of asthma and other respiratory conditions.

Why did GSK stop manufacturing the branded version of Flovent HFA?

GSK stopped manufacturing the branded version of Flovent HFA due to regulatory changes and financial disincentives introduced by the American Rescue Plan Act.

What are the consequences of switching to the generic version of Flovent?

The switch to the generic version has led to increased costs for some patients and a significant increase in asthma-related hospitalizations.

Are there any new treatments for asthma being developed by GSK?

Yes, GSK is developing depemokimab, an ultra-long-acting biologic with a six-month dosing schedule, which has shown promising results in phase III trials for severe asthma.

What are some common adverse reactions associated with Flovent?

Common adverse reactions include upper respiratory tract infections, throat irritation, and candidiasis of the mouth and throat.

Sources

1. Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone - Rethinking Clinical Trials.
2. Discontinuation of popular asthma medication, Flovent, linked to increased hospitalization - ABC News.
3. GSK announces positive results from phase III severe asthma trials of depemokimab - GSK.
4. HIGHLIGHTS OF PRESCRIBING INFORMATION - GSK Pro.
5. Senator claims GSK pulled popular asthma med to dodge inhaler price caps - FiercePharma.