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Flovent Rotadisk (Fluticasone Propionate Inhalation) - Summary

 
 



SUMMARY

The active component of FLOVENT ROTADISK 50 mcg, FLOVENT ROTADISK 100 mcg, and FLOVENT ROTADISK 250 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl)6(alpha),9-difluoro-11(beta),17-dihydroxy- 16(alpha)-methyl-3-oxoandrosta-1,4-diene-17(beta)-carbothioate, 17-propionate.

FLOVENT ROTADISK is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.

FLOVENT ROTADISK is NOT indicated for the relief of acute bronchospasm.


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NEWS HIGHLIGHTS

Media Articles Related to Flovent Rotadisk (Fluticasone Inhalation)

Asthma Inhalers, Epinephrine Autoinjectors Often Misused
Source: Medscape Allergy & Clinical Immunology Headlines [2014.12.19]
Only 7% of inhaler users and 16% of patients with epinephrine autoinjectors were able to demonstrate correct use of their device in a recent study.
Medscape Medical News

Parent-Toddler Bed-Sharing May Increase Asthma Risk
Source: Medscape Allergy & Clinical Immunology Headlines [2014.12.15]
The risk of developing asthma by age 6 years may be greater in children who share a bed with their parents early in life.
Medscape Medical News

Asthma risks 'may be boosted by energy efficient homes'
Source: Respiratory / Asthma News From Medical News Today [2014.12.15]
A study from UK-based researchers suggests that the British government's drive toward more energy efficient homes may have adverse effects for occupants with asthma.

VR475 shown significant benefit in a Phase IIb/III trial for severe asthma
Source: Respiratory / Asthma News From Medical News Today [2014.12.12]
Vectura Group plc has announced the publication in the European Respiratory Journal (ERJ) of a clinical study demonstrating positive results from its Phase IIb/III (Acti-AICS-001) clinical trial...

Asthma
Source: MedicineNet Allergy Specialty [2014.12.12]
Title: Asthma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/12/2014 12:00:00 AM

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Published Studies Related to Flovent Rotadisk (Fluticasone Inhalation)

Fluticasone impact on airway dendritic cells in smokers: a randomized controlled trial. [2013]
DCs in smokers are unknown... CONCLUSIONS: Resistance to ICS monotherapy in smokers might in part be due to

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.

Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler. [2011.05]
BACKGROUND: Fluticasone and formoterol are well established medications for the treatment of asthma. This study (Clinicaltrials.gov identifier: NCT00734318) compares the efficacy and safety of a combination of these drugs in a single inhaler (fluticasone/formoterol) versus the individual components (fluticasone + formoterol)... CONCLUSION: This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers. Fluticasone/formoterol (500/20 mug, b.i.d.) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinically important parameters. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers. [2011.04]
PURPOSE: This study compares the in vivo relative lung bioavailability of Hydrofluoroalkane (HFA) Seretide delivered via unprimed and unwashed Aerochamber Plus (AP) or Volumatic (VM) spacers, a integrated breath-actuated vortex Synchro-Breathe (SB) device and an Evohaler pMDI (EH) device using adrenal suppression and early fall in serum potassium (K) as surrogates for respirable dose... CONCLUSIONS: The breath-actuated SB device was comparable to 'out of the box' small and large volume spacers and produced similar improvements in relative systemic lung bioavailability for fluticasone and salmeterol.

Difference between patient-reported side effects of ciclesonide versus fluticasone propionate. [2010.12]
RATIONALE: Patient-reported outcomes provide new insights into the dynamics of asthma management. Further to asthma control and quality of life, self-reported side effects of treatment can be assessed with the validated Inhaled Corticosteroid Questionnaire (ICQ). OBJECTIVES: To compare patient-reported side effects between the inhaled corticosteroids ciclesonide and fluticasone propionate... CONCLUSION: Patient-perceived side effects differ depending on the type of inhaled corticosteroids used. Patients with moderate-to-severe asthma report less intense side effects assessed with ICQ with ciclesonide than with fluticasone propionate. CLINICAL TRIAL REGISTRATION: The reported trials were completed before July 1 2005 and, therefore, are not registered. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

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Clinical Trials Related to Flovent Rotadisk (Fluticasone Inhalation)

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.

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.

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Page last updated: 2014-12-19

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