CUTIVATE SUMMARY
CUTIVATE (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6(alpha),11(beta),16 (alpha),17 (alpha))-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 Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE Cream in pediatric patients below 3 months of age have not been established.
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CUTIVATE NEWS HIGHLIGHTS
Published Studies Related to Cutivate (Fluticasone Topical)
Preemptive use of high-dose fluticasone for virus-induced wheezing in young children. [2009.01.22]
BACKGROUND: Although virus-induced wheezing is common in preschool-age children, optimal management remains elusive. We examined the efficacy and safety of preemptive treatment with high-dose fluticasone in reducing the severity of recurrent virus-induced wheezing in children... CONCLUSIONS: In preschool-age children with moderate-to-severe virus-induced wheezing, preemptive treatment with high-dose fluticasone as compared with placebo reduced the use of rescue oral corticosteroids. Treatment with fluticasone was associated with a smaller gain in height and weight. Given the potential for overuse, this preventive approach should not be adopted in clinical practice until long-term adverse effects are clarified. (ClinicalTrials.gov number, NCT00238927.) 2009 Massachusetts Medical Society
Bronchodilator reversibility, airway eosinophilia and anti-inflammatory effects of inhaled fluticasone in COPD are not related. [2008.11]
BACKGROUND AND OBJECTIVE: Bronchodilator reversibility (BDR) is common in smoking-related COPD, but the airway pathology underlying this has not been described. In particular, it is not known whether BDR is associated with underlying airway eosinophilia and whether BDR is predictive of a better response to inhaled corticosteroid (ICS) treatment... CONCLUSIONS: BDR was not related to any particular inflammatory phenotype or any clinical or anti-inflammatory response to ICS in these subjects with mild to moderate COPD.
Fluticasone or montelukast for preschool children with asthma-like symptoms: Randomized controlled trial. [2008.10]
RATIONALE: Beneficial effects of anti-inflammatory therapy such as fluticasone propionate (FP) and montelukast (Mk) have been demonstrated in preschool children with asthma. However, comparative studies are lacking in this age group. Therefore, we conducted a study to evaluate and compare the effect of FP and Mk in preschool children with asthma-like symptoms... CONCLUSIONS: In spite of a lack of power, our results suggest that FP has a beneficial effect on symptoms and Mk on blood eosinophil level as compared to placebo. Except for a difference in one lung function parameter after 3 months between FP and Mk in favor of the FP group, this study revealed no differences between FP and Mk.
Deterioration in asthma control when subjects receiving fluticasone propionate/salmeterol 100/50 mcg Diskus are "stepped-down". [2008.10]
In this study, 647 subjects stable on fluticasone propionate/salmeterol Diskus 100/50 mcg BID (FSC) were randomized to continue FSC 100/50 mcg BID or "step down" to either fluticasone propionate (FP) 100 mcg BID, salmeterol (SAL) 50 mcg BID, or montelukast (MON) 10 mg once daily for 16 weeks.
Effectiveness of high repeated doses of inhaled budesonide or fluticasone in controlling acute asthma exacerbations in young children. [2008.09]
OBJECTIVE: The role of inhaled corticosteroids in the treatment of acute asthma exacerbations in children is controversial. This study compared the effect of inhaled budesonide and inhaled fluticasone in controlling acute asthma exacerbations in young children at home... CONCLUSION: Acute asthma exacerbations in young children can be effectively controlled at home with the use of high repetitive doses of inhaled budesonide or inhaled fluticasone, initially together with beta(2)-agonists, given at the beginning of the attack, for a period of 4-8 days.
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: 2009-02-07
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