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Last Updated: October 27, 2020

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CLINICAL TRIALS PROFILE FOR FLUTICASONE FUROATE

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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 N/A 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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

Clinical Trial Conditions for Fluticasone Furoate

Condition Name

Condition Name for Fluticasone Furoate
Intervention Trials
Asthma 54
Pulmonary Disease, Chronic Obstructive 39
Rhinitis, Allergic, Perennial 11
Seasonal Allergic Rhinitis 8
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Condition MeSH

Condition MeSH for Fluticasone Furoate
Intervention Trials
Pulmonary Disease, Chronic Obstructive 42
Lung Diseases 42
Chronic Disease 39
Asthma 36
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Clinical Trial Locations for Fluticasone Furoate

Trials by Country

Trials by Country for Fluticasone Furoate
Location Trials
United States 657
Germany 246
China 64
Canada 53
Argentina 51
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Trials by US State

Trials by US State for Fluticasone Furoate
Location Trials
South Carolina 41
Texas 39
California 38
Florida 35
Ohio 33
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Clinical Trial Progress for Fluticasone Furoate

Clinical Trial Phase

Clinical Trial Phase for Fluticasone Furoate
Clinical Trial Phase Trials
Phase 4 34
Phase 3 62
Phase 2 18
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Clinical Trial Status

Clinical Trial Status for Fluticasone Furoate
Clinical Trial Phase Trials
Completed 106
Recruiting 12
Active, not recruiting 8
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Clinical Trial Sponsors for Fluticasone Furoate

Sponsor Name

Sponsor Name for Fluticasone Furoate
Sponsor Trials
GlaxoSmithKline 119
Merck Sharp & Dohme Corp. 5
Parexel 5
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Sponsor Type

Sponsor Type for Fluticasone Furoate
Sponsor Trials
Industry 138
Other 23
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