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)
Add-on salmeterol compared to double dose fluticasone in pediatric asthma: A double-blind, randomized trial (VIAPAED). [2009.10.12]
RATIONALE: In asthmatic children whose symptoms are uncontrolled on standard doses of inhaled corticosteroids (ICS), guidelines recommend to either increase the ICS dose or to add further controller medication, e.g. a long acting ss2-agonist (LABA). The aim of this study was to compare the efficacy and safety of doubling the dose of ICS (fluticasone proprionate FP 200 microg twice daily) with adding a long-acting beta-2 agonist to the ICS (SFC, salmeterol 50 microg/ FP 100 microg twice daily) in children with uncontrolled asthma... CONCLUSIONS: In children with persistent asthma inadequately controlled on low dose ICS alone, adding a long acting beta-2-agonist to ICS in a single inhaler was more effective than doubling the ICS dose. These results support recommendations of adding LABA to low-dose ICS as the preferred controller option for children older than 4 years with symptomatic asthma. Pediatr Pulmonol. (c)2009 Wiley-Liss, Inc.
A novel breath-actuated integrated vortex spacer device increases relative lung bioavailability of fluticasone/salmeterol in combination. [2009.08]
BACKGROUND: Spacer devices facilitate respirable drug delivery. A novel breath-actuated antistatic spacer with integrated vortex chamber (Synchro-Breathe) device has been developed, which is compact,portable and user friendly as compared to conventional spacers which are bulky and cumbersome. The relative bioavailability to the lung of inhaled fluticasone and salmeterol combination is primarily dependent on respirable dose delivery and can be reliably quantified using adrenal suppression and early fall in serum potassium (marker of systemic beta-2 adrenoreceptor response) as surrogate markers for delivered lung dose. AIMS AND OBJECTIVES: To compare the in vivo relative bioavailability to the lung of Hydrofluoroalkane(HFA) Seretide delivered via Synchro-Breathe (SB); an optimally prepared 750 ml large volume plastic spacer, Volumatic (VM); and conventional Evohaler pMDI (EH)... CONCLUSION: The breath-actuated Synchro-Breathe device was comparable to an optimally prepared Volumatic spacer, and resulted in commensurate improvement in relative lung bioavailability for both fluticasone and salmeterol moieties compared to pMDI.
Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. [2009.06.30]
BACKGROUND: The efficacy of inhaled salmeterol plus fluticasone propionate (SFC) in patients with severe or very severe COPD is well documented. However, there are only limited data about the influence of GOLD severity staging on the effectiveness of SFC, particularly in patients with milder disease... CONCLUSION: In the TORCH study, SFC reduced moderate-to-severe exacerbations and improved health status and FEV1 across GOLD stages. Treatment with SFC may be associated with reduced mortality compared with placebo in patients with GOLD stage II disease. The effects were similar to those reported for the study as a whole. Thus, SFC is an effective treatment option for patients with GOLD stage II COPD. TRIAL REGISTRATION: Clinicaltrial.gov registration NCT00268216; Study number: SCO30003.
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis. [2009.06.18]
BACKGROUND: Both gastroesophageal reflux disease and allergy/atopy have been implicated in the pathogenesis of eosinophilic esophagitis (EoE). There are no prospective studies comparing treatment of EoE with acid suppression versus topical corticosteroids. OBJECTIVE: To determine the outcome of adult eosinophilic esophagitis patients treated with esomeprazole versus topical fluticasone... CONCLUSIONS: Gastroesophageal reflux disease is common in adult eosinophilic esophagitis patients. Dysphagia improves and esophageal eosinophilic infiltration decreases with either treatment. There was no difference in degree of improvement in dysphagia or eosinophil infiltration in patients treated with either topical fluticasone or oral esomeprazole. GERD may be important in the pathogenesis of adult EoE.
Fluticasone furoate nasal spray reduces the nasal-ocular reflex: a mechanism for the efficacy of topical steroids in controlling allergic eye symptoms. [2009.06]
BACKGROUND: Eye symptoms frequently occur in patients with allergic rhinitis and are among the most bothersome symptoms. Intranasal steroids have been shown to reduce ocular symptoms associated with allergic nasal symptoms, even though they do not reach the eye. OBJECTIVE: To elucidate a mechanism to explain these observations... CONCLUSIONS: We confirmed that a nasal-ocular reflex follows nasal challenge with allergen and that it can contribute to the ocular symptoms associated with allergic rhinitis. FFNS reduced eosinophil infiltration, priming, and ocular symptoms. Furthermore, our results support a mechanism by which control of eye symptoms can be achieved during nasal administration of an intranasal steroid in patients with seasonal allergic rhinitis.
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
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.
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis [Completed]
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.
Comparator Study Evaluating Patient Preference Of Fluticasone Furoate Nasal Spray vs. Fluticasone Propionate Nasal Spray [Completed]
The purpose of this replicate study to FFU105927 is to provide data on subject preference of
FFNS as compared with FPNS.
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Page last updated: 2009-10-20
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