CLINICAL TRIALS PROFILE FOR FLUTICASONE FUROATE

505(b)(2) Clinical Trials for Fluticasone Furoate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01337323 ↗	Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting	Terminated	GlaxoSmithKline		2010-09-01	This study is a prospective observational cohort study with 3-month follow-up among a cohort of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal spray (FFNS). The primary aim is to examine the effect of FFNS on the use and associated cost of concomitant allergic rhinitis medications in INS-experienced patients starting treatment with FFNS who have a history of prior concomitant medication use. The secondary aim will be to determine the effect of FFNS on control of allergic rhinitis, as assessed by the Rhinitis Control Assessment Test (RCAT). Adult patients filling a new FFNS prescription will be recruited (within 4 days of starting their FFNS) across 50 branches of a retail pharmacy chain with co-located convenient care clinics. Approximately 350 patients who have active seasonal rhinitis and have used an INS other than FFNS and another prescription or over-the-counter allergy medication in the previous allergy season will be eligible for the study. A baseline questionnaire will be administered to collect information on patient demographics, a brief medical history of the patient's rhinitis, prior use of INS and other prescription and over-the-counter medications taken for allergic rhinitis, total out of pocket costs for the prior allergy season, number of office visits due to allergic rhinitis, and level of control of symptoms of allergic rhinitis. At 1, 2, and 3 months post-enrollment, a follow-up questionnaire will be administered to collect information on medications taken for allergic rhinitis, office visits due to rhinitis, and level of control of symptoms of allergic rhinitis. In addition, pharmacy claims data will be abstracted for patients 1 year prior to enrollment and 4 months after enrollment to verify and supplement patient reported data as needed. The primary outcomes will be rate of use of non-INS concomitant medications (frequency and duration) at baseline, and 1, 2, and 3 months follow-up and change in rate of use of non-INS concomitant medications (post vs. pre and from baseline to 3 months follow-up). Secondary outcomes will be change in total allergic rhinitis pharmacy expenditures (post vs. pre and from baseline to follow-up) and change in the level of control of allergic rhinitis, as measured by score on the Rhinitis Control Assessment Test (RCAT), from baseline to follow-up.

All Clinical Trials for Fluticasone Furoate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00109486 ↗	Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray	Completed	GlaxoSmithKline	Phase 3	2005-04-01	The purpose of this study is to assess any effect in children with seasonal and/or perennial allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on growth using knemometry.
NCT00115622 ↗	Study In Adults And Adolescents With Seasonal Allergic Rhinitis	Completed	GlaxoSmithKline	Phase 3	2004-12-01	The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
NCT00116818 ↗	A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults	Completed	GlaxoSmithKline	Phase 3	2005-01-01	The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.
NCT00379288 ↗	Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-06-01	The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind. In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.
NCT00394355 ↗	Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2006-09-01	This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus montelukast (ML) 10 mg daily in the evening.
NCT00398476 ↗	Fluticasone Nasal Spray Patient Preference Study	Completed	GlaxoSmithKline	Phase 3	2006-12-01	The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.

Clinical Trial Conditions for Fluticasone Furoate

Condition Name

Condition Name for Fluticasone Furoate
Intervention	Trials
Asthma	61
Pulmonary Disease, Chronic Obstructive	41
Rhinitis, Allergic, Perennial	12
Seasonal Allergic Rhinitis	8

Condition MeSH

Condition MeSH for Fluticasone Furoate
Intervention	Trials
Asthma	47
Pulmonary Disease, Chronic Obstructive	45
Lung Diseases	44
Chronic Disease	39

Clinical Trial Locations for Fluticasone Furoate

Trials by Country

Trials by Country for Fluticasone Furoate
Location	Trials
United States	798
Germany	259
Canada	72
China	68
Italy	63

Trials by US State

Trials by US State for Fluticasone Furoate
Location	Trials
Texas	48
South Carolina	46
California	44
Florida	39
Ohio	38

Clinical Trial Progress for Fluticasone Furoate

Clinical Trial Phase

Clinical Trial Phase for Fluticasone Furoate
Clinical Trial Phase	Trials
Phase 4	42
Phase 3	71
Phase 2	18

Clinical Trial Status

Clinical Trial Status for Fluticasone Furoate
Clinical Trial Phase	Trials
Completed	132
Not yet recruiting	9
Recruiting	7

Clinical Trial Sponsors for Fluticasone Furoate

Sponsor Name

Sponsor Name for Fluticasone Furoate
Sponsor	Trials
GlaxoSmithKline	126
Parexel	6
Merck Sharp & Dohme Corp.	6

Sponsor Type

Sponsor Type for Fluticasone Furoate
Sponsor	Trials
Industry	152
Other	37
NIH	2

Fluticasone Furoate: Clinical Trials Update, Market Analysis, and Projections

Introduction to Fluticasone Furoate

Fluticasone furoate is a corticosteroid commonly used in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). It is administered via inhalation and is known for its anti-inflammatory properties. Here, we will delve into the recent clinical trials, market analysis, and future projections for fluticasone furoate.

Clinical Trials Update: ACTIV-6 Study

One of the most significant recent clinical trials involving fluticasone furoate is the ACTIV-6 study, part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative. This study aimed to evaluate the efficacy of repurposed medications, including fluticasone furoate, in treating mild-to-moderate COVID-19 symptoms.

Key Findings of the ACTIV-6 Study

• The study, led by the Duke Clinical Research Institute (DCRI) in partnership with Vanderbilt University, enrolled 1,127 participants across the United States over eight months. Participants were randomized to receive either 200 mcg of fluticasone furoate per day or a matching placebo inhaler for 14 days[1][4].
• The results showed no evidence of improvement in time to recovery or reduction in hospitalizations among participants who took fluticasone furoate compared to those who received the placebo. There were also no safety concerns identified, confirming that fluticasone furoate is safe to use as prescribed for its approved indications[1][4].

Implications for COVID-19 Treatment

The findings from the ACTIV-6 study indicate that fluticasone furoate does not offer any clinical benefit for the treatment of mild-to-moderate COVID-19 symptoms. This is crucial information for healthcare providers and patients, as it helps to rule out fluticasone furoate as a potential therapeutic option for COVID-19[1][4].

Market Analysis

Global Market Size and Growth

The global market for fluticasone propionate inhalers, which includes fluticasone furoate, was valued at approximately USD 5.6 billion in 2023. This market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.6% and reach USD 8.1 billion by 2032[2].

Driving Factors

The growth of the fluticasone propionate inhalers market is driven by several factors, including:

• Increasing Incidence of Respiratory Problems: The rising prevalence of asthma, COPD, and other respiratory diseases is a significant driver.
• Technological Advancements: Improvements in inhaler technology and the development of more effective formulations are also contributing to market growth[2].

Market Segmentation

The market is segmented based on type and application:

• Type: Includes 60 metered sprays, 120 metered sprays, and 150 metered sprays.
• Application: Classified into use for kids and adults[2].

Projections and Future Outlook

Market Growth Projections

The fluticasone propionate inhalers market is expected to continue growing, driven by the increasing demand for effective treatments for respiratory conditions. The projected CAGR of 4.6% indicates a steady and significant growth trajectory up to 2032[2].

Regional Analysis

The market is analyzed across various regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Each region has its own growth prospects and challenges:

• North America: Expected to remain a major market due to high healthcare spending and advanced healthcare infrastructure.
• Europe: Also anticipated to be a significant market, driven by a large patient population and strong healthcare systems.
• Asia Pacific: This region is expected to show rapid growth due to increasing healthcare expenditure and a large population base[5].

Safety and Efficacy

Safety Profile

The ACTIV-6 study and other clinical trials have confirmed that fluticasone furoate is safe when used as prescribed. There were no safety concerns identified in the ACTIV-6 study, reinforcing its safety profile for its approved indications[1][4].

Efficacy in Approved Indications

While fluticasone furoate did not show efficacy in treating COVID-19, it remains effective for its approved uses, such as the maintenance treatment of asthma and COPD. Its anti-inflammatory properties make it a valuable medication in managing these chronic respiratory conditions[1][3].

Key Takeaways

• No Clinical Benefit for COVID-19: Fluticasone furoate did not show any benefit in treating mild-to-moderate COVID-19 symptoms.
• Market Growth: The global market for fluticasone propionate inhalers is expected to grow at a CAGR of 4.6% up to 2032.
• Safety Profile: Fluticasone furoate is safe when used as prescribed for its approved indications.
• Regional Growth: Different regions will contribute to the market growth, with North America and Europe being significant contributors.

FAQs

What was the outcome of the ACTIV-6 study regarding fluticasone furoate for COVID-19 treatment?

The ACTIV-6 study found no evidence of improvement in time to recovery or reduction in hospitalizations for participants who took fluticasone furoate compared to those who received a placebo[1][4].

What is the projected market size for fluticasone propionate inhalers by 2032?

The market is expected to reach USD 8.1 billion by 2032, growing at a CAGR of 4.6%[2].

What are the driving factors for the growth of the fluticasone propionate inhalers market?

The growth is driven by the increasing incidence of respiratory problems and technological advancements in inhaler technology[2].

Is fluticasone furoate safe to use?

Yes, fluticasone furoate is safe when used as prescribed for its approved indications, as confirmed by the ACTIV-6 study and other clinical trials[1][4].

What are the approved indications for fluticasone furoate?

Fluticasone furoate is approved for the maintenance treatment of asthma and other respiratory conditions, but not for the treatment of COVID-19[1][3].

Sources

1. Duke Clinical Research Institute, "ACTIV-6 trials show no benefit to fluticasone furoate for COVID-19 symptoms," September 21, 2023.
2. Business Research Insights, "Fluticasone Propionate Inhalers Market Size, Share & Report, 2032," November 25, 2024.
3. Synapse, "Fluticasone furoate - Drug Targets, Indications, Patents."
4. Rethinking Clinical Trials, "Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone," July 27, 2022.
5. Transparency Market Research, "Nasal Corticosteroids Market Size, Share & Trends Report, 2034."