FLONASE SUMMARY
FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg
For Intranasal Use Only. SHAKE GENTLY BEFORE USE.
Fluticasone propionate, the active component of FLONASE Nasal Spray, is a synthetic 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.
FLONASE Nasal Spray is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older.
Safety and effectiveness of FLONASE Nasal Spray in children below 4 years of age have not been adequately established.
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NEWS HIGHLIGHTSMedia Articles Related to Flonase (Fluticasone Nasal)
fluticasone propionate nasal inhaler-spray, Flonase, Veramyst Source: MedicineNet beclomethasone dipropionate nasal inhaler-spray Specialty [2008.04.14] Title: fluticasone propionate nasal inhaler-spray, Flonase, Veramyst Category: Medications Created: 3/26/1998 2:30:00 PM Last Editorial Review: 4/14/2008
Tobacco Smoke Has Harmful Impact On Asthma, Rhinitis And Immunity Source: Respiratory / Asthma News From Medical News Today [2009.11.10] Tobacco smoke is involved in uncontrolled asthma, a diminished response to anti-asthma drugs, rhinitis, nasal obstruction, and deregulation of the immune system according to an international expert at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Miami Beach, Fla.
Treatment Of Allergic Rhinitis Improves Coexisting Diseases Source: Allergy News From Medical News Today [2009.11.09] The treatment of allergic rhinitis is shown to improve co-existing conditions including conjunctivitis, asthma, sinusitis, otitis media with effusion (fluid in the middle ear) and sleep disorders according to an international expert at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Miami Beach, Fla.
Chronic Rhinitis and Post-Nasal Drip Source: MedicineNet Eustachian Tube Problems Specialty [2008.07.21] Title: Chronic Rhinitis and Post-Nasal Drip Category: Diseases and Conditions Created: 7/13/1998 Last Editorial Review: 7/21/2008
Allergy drug tackles nasal congestion: study (Reuters) Source: Y! Health Allergy News [2009.11.12] Reuters - The "second generation" allergy drug desloratadine (brand name Clarinex) significantly reduces both the runny nose and congestion of seasonal and persistent allergic rhinitis, a study shows.
Published Studies Related to Flonase (Fluticasone Nasal)
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 Flonase (Fluticasone Nasal)
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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 20 ratings/reviews, Flonase has an overall score of 8.50. The effectiveness score is 8.70 and the side effect score is 9.10. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Flonase review by 46 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | | Treatment Info |
| Condition / reason: | | allergies |
| Dosage & duration: | | 2 sprays in each nostril (dosage frequency: as needed) for the period of still taking it |
| Other conditions: | | Mostly sinus pressure |
| Other drugs taken: | | Claratin | | | Reported Results |
| Benefits: | | This spray clears the nasal passages to promote free breathing. I've tried over the counter remedies but they are harsh and you end up practically addicted to them. This works much the same way but is non-addictive and need only be used when symptoms hit. I have used this same product when I've had a head cold and achieved the same results. I'm pretty sure that's not what it's intended for but whenever I've got sinus pressure, I take this product. |
| Side effects: | | I've experienced no side effects. |
| Comments: | | Simply shake the bottle, and use 2 sprays in each nostril daily. |
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| | Flonase review by 30 year old male patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | | Treatment Info |
| Condition / reason: | | sinus allergy |
| Dosage & duration: | | 2 sprays daily (dosage frequency: daily) for the period of 2 weeks |
| Other conditions: | | None |
| Other drugs taken: | | None | | | Reported Results |
| Benefits: | | Relief for my nasal clogging and breaht normally. Works great! |
| Side effects: | | I've experienced no side effects, although there was some mild headache during the first day of use- this could have been due to other reasons. |
| Comments: | | Moved to a new area with a lot of trees / greenry and experiecing temporary allergies while there. got prescribed flonase with dosage described above, and felt much better. |
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| | Flonase review by 50 year old male patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Marginally Effective |
| Side effects: | | No Side Effects | | | Treatment Info |
| Condition / reason: | | allergy |
| Dosage & duration: | | 1 spray (dosage frequency: once per day) for the period of 3 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | | Reported Results |
| Benefits: | | none |
| Side effects: | | none |
| Comments: | | daily use for three months with little to no effect |
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Page last updated: 2009-11-12
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