CUTIVATE SUMMARY
CUTIVATE®
(fluticasone propionate ointment)
Ointment, 0.005%
CUTIVATE® (fluticasone propionate ointment) Ointment, 0.005% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
CUTIVATE® Ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.
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NEWS HIGHLIGHTS
Published Studies Related to Cutivate (Fluticasone Topical)
MP29-02 (a novel intranasal formulation of azelastine hydrochloride and
fluticasone propionate) in the treatment of seasonal allergic rhinitis: a
randomized, double-blind, placebo-controlled trial of efficacy and safety. [2012]
Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite
available treatment options. This study was designed to evaluate the efficacy and
safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP]
and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and
placebo sprays for the treatment of seasonal allergic rhinitis (SAR)...
Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial. [2011.10.06]
ABSTRACT: BACKGROUND: Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebo-controlled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma... CONCLUSIONS: FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated once-daily treatment for mild-to-moderate asthma. TRIAL REGISTRATION: NCT00398645.
Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. [2011.09]
BACKGROUND: COPD is associated with increased arterial stiffness which may in part explain the cardiovascular morbidity observed in the disease. A causal relationship between arterial stiffness and cardiovascular events has not been established, though their strong association raises the possibility that therapies that reduce arterial stiffness may improve cardiovascular outcomes. Prior studies suggest that fluticasone propionate/salmeterol (FSC) may improve cardiovascular outcomes in COPD and we hypothesized that FSC would reduce arterial stiffness in these patients... CONCLUSION: FSC does not reduce aPWV in all patients with moderate to severe COPD, but may have effects in those with elevated arterial stiffness. Additional studies are required to determine if aPWV could serve as a surrogate for cardiovascular events in COPD. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
[Cost effectiveness of treatment with salmeterol/fluticasone compared to montelukast for the control of persistent asthma in children]. [2011.07]
OBJECTIVE: To assess the incremental cost-effectiveness of SFC compared with MON for the control of persistent asthma in children... CONCLUSIONS: This analysis demonstrates that, compared with MON, SFC may be cost saving from the Mexican health care perspective for the treatment of pediatric patients with asthma. SFC provided a reduction in the number of severe exacerbations, frequent asthma symptoms and rescue medication use. Incremental cost-effectiveness analysis indicated the dominance of SFC because of both lower costs and greater efficacy. Copyright (c) 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Long-term monotherapy with suplatast tosilate in patients with mild atopic asthma: a pilot comparison with low-dose inhaled fluticasone. [2011.06]
BACKGROUND AND OBJECTIVE: Suplatast tosilate is a Th2 cytokine inhibitor that is effective for controlling persistent asthma. However, the long-term efficacy of suplatast is unknown. We compared the clinical efficacy of long-term monotherapy with suplatast tosilate with a low dose of inhaled steroids in patients with mild atopic asthma... CONCLUSIONS: Long-term treatment with suplatast significantly improved symptoms and inflammatory indices in patients with mild atopic asthma. Along with fluticasone, suplatast is considered a useful drug for the management of mild atopic asthma.
Clinical Trials Related to Cutivate (Fluticasone Topical)
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 [Active, not recruiting]
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
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 [Active, not recruiting]
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
Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays [Recruiting]
The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the
relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed
AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE
(i. e. FLU alone in the MP29-02 vehicle; REF).
The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when
administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product,
Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of
AZE on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess
adverse events.
Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics [Recruiting]
The purpose of the study is to compare the efficacy and safety of fluticasone
furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with
fluticasone furoate inhalation powder administered alone once daily each evening in
adolescent and adult subjects 12 years of age and older with persistent bronchial asthma
over a 24-week period.
Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics [Completed]
A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone
propionate and salmeterol was compared with concurrent administration of fluticasone
propionate and salmeterol. Administration occurred over 14 days and tolerability, PK
(pharmacokinetic) and PD (pharmacodynamic) measurements were performed.
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