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Flonase (Fluticasone)

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Flonase is a nasal spray containing the corticosteriod fluticasone. It prevents the release of substances in the body that cause inflammation.

Other names for this medication:

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Also known as:  Fluticasone.


Flonase is a nasal spray containing the corticosteriod fluticasone. It prevents the release of substances in the body that cause inflammation.

Flonase is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies.

Flonase is for use in adults and children who are at least 2 years old.

Flonase may also be used for purposes other than those listed.

Generic name of Flonase is Fluticasone.

Flonase is also known as Fluticasone, Flonase, Veramyst.


Follow the directions for using this medicine provided by your doctor. Use Flonase exactly as directed.

Before using the spray for the first time, you must prime the spray pump. Shake the medicine well and spray 6 test sprays into the air and away from your face. Prime the spray pump any time you have not used your nasal spray for longer than 30 days, or if you have left the cap off for 5 days or longer. Spray until a fine mist appears.

The usual dose of Flonase is 1 to 2 sprays into each nostril once per day. Your doctor may change your dose after your symptoms improve.

Shake the medicine bottle well just before each use.

It may take up to several days before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a week of treatment.


An overdose of Flonase is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.


Store at a room temperature between 15 and 30 degrees C (59 and 86 degrees F) away from moisture and heat. Throw the medication away after you have used 120 sprays, even if there is still medicine left in the bottle. Keep out of the reach of children.

Side effects

The most common side effects associated with Flonase are:

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Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.


You should not use Flonase if you are allergic to fluticasone nasal, or if you are also taking ritonavir (Norvir, Kaletra).

It is not known whether Flonase will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant or breast-feeding.

Be careful with Flonase if you have glaucoma or cataracts; liver disease; herpes simplex virus of your eyes; tuberculosis or any other infection or illness; sores or ulcers inside your nose; or if you have recently had injury of or surgery on your nose.

Be careful with Flonase if you are taking: conivaptan (Vaprisol); imatinib (Gleevec); isoniazid (for treating tuberculosis); nefazodone; an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek); antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend); heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G); HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), or saquinavir (Invirase).

Do not give this medicine to a child younger than 2 years old without medical advice.

Do not stop taking Flonase suddenly.

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Budesonide/formoterol pMDI administered twice daily is effective and generally well tolerated in patients whose asthma is not well controlled on ICS alone.

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Culture of ASM on collagen I, but not laminin, led to a greater proliferative response that was insensitive to regulation by dexamethasone (100 nM). The anti-migratory effects of the glucocorticoid, fluticasone propionate (1 nM) were also impaired by contact of ASM with collagen. The impaired anti-mitogenic action of dexamethasone was associated with a failure to reduce the levels of the rate-limiting cell cycle regulatory protein, cyclin D1. When signalling through the alpha2beta1 integrin was reduced, dexamethasone-mediated reductions in proliferation and cyclin D1 levels were restored.

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Eighteen subjects completed the initial dose titration and 13 completed the protocol. Of these, 7 weaned off ICS completely and 6 had exacerbations. FENO rose significantly with ICS withdrawal, though there was heterogeneity in the starting level and the degree of rise. EBC pH was collected at home in all subjects and fell more in subjects who had an exacerbation than in those who did not. The decrease in pH was associated with hazard of exacerbation.

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The PATHOS study demonstrated a significant reduction in COPD hospitalizations and pneumonia-related hospitalizations in patients treated with budesonide/formoterol versus fluticasone/salmeterol (-29.1% and -42%, respectively). In the base case, the treatment of a patient for 1 year with budesonide/formoterol led to a saving of €499.90 (€195.10 for drugs, €193.10 for COPD hospitalizations, and €111.70 for pneumonia hospitalizations) corresponding to a -27.6% difference compared with fluticasone/salmeterol treatment.

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The effect of the long acting beta(2)-agonist/corticosteroid combination salmeterol-fluticasone propionate (SFC) on respiratory muscles and ventilation in severe COPD is unknown. As COPD hyperinflation worsens, diaphragm efficiency decreases, and a compensatory increase in chest wall inspiratory muscle activity occurs. If a bronchodilator successfully alleviates hyperinflation and improves diaphragm efficiency in severe COPD, then the extraordinary activation of the chest wall may be relieved. We examined directly the effect on the parasternal intercostal respiratory chest wall muscle and ventilation of four puffs of salmeterol 25 microg and fluticasone propionate 125 microg via the metered dose combination inhaler in 12 patients with severe Global Initiative on Obstructive Lung Disease stage III-IV COPD, mean FEV(1) = 0.91 L (32% predicted).

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Mean daily per person cost-efficacy ratios using improvement in forced expiratory volume in 1 second (FEV1) [> or = 12% increase from baseline] were $US 3.47 for fluticasone propionate compared with $US 7.81 for zafirlukast (1999 values). The mean daily per person cost-efficacy ratios for symptom-free days obtained were $US 5.51 for fluticasone propionate compared with $US 14.98 for zafirlukast. These cost-efficacy ratios remained in favour of fluticasone propionate after a robust sensitivity analysis.

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Patients ≥ 12 years (N = 210) with mild to moderate-severe persistent, reversible asthma were evenly randomised to 12 weeks of treatment (b.i.d.) with fluticasone/formoterol combination therapy (100/10 μg b.i.d. or 250/10 μg b.i.d.) or fluticasone plus formoterol (Flixotide Evohaler, pMDI, Flovent [HFA]; Foradil, DPI, Foradil Aerolizer) administered concurrently (fluticasone + formoterol; 100 μg + 12 μg b.i.d. or 250 μg + 12 μg b.i.d.) in an open-label, parallel-group, multicentre study. The primary objective of this study was to show non-inferiority of fluticasone/formoterol compared with fluticasone + formoterol based on mean post-dose FEV1.

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Patient compliance with inhaled corticosteroids (ICS) in asthma is considered to be suboptimal.

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This dose-ranging study evaluated the clinical efficacy and safety of inhaled fluticasone propionate administered once daily via a multidose powder inhaler in patients with moderate asthma (FEV(1), 45 to 75% predicted).

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To examine the systemic effects of single and chronic doses of salmeterol 100 microg.

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Steroid exposure resulted in epithelial injury as measured by a significant increase in the number of airway epithelial cells in induced sputum. There was no change in airway inflammation by induced sputum inflammatory cell counts or cytokine levels. Epithelial shedding was associated with an increase in barrier function, as measured by both a decrease in DTPA clearance and decreased albumin in induced sputum. This likely reflects the normal repair response.

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This double-blind placebo-controlled randomized study was performed in order to investigate whether fluticasone propionate aqueous nasal spray (FPANS) reduces the recurrence rate of nasal polyps and chronic rhinosinusitis during the first year after FESS.

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Whole NCSA rate was 17.9%; it was 21.4% for AR patients and 15.9% for control group, respectively (p>0.05). Treatment with intranasal fluticasone propionate spray did not influence NCSA in AR patients.

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To determine the efficacy of drug therapies in the specific treatment of sleep apnoea.

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Subjects using only as-needed albuterol were screened and completed two sequential open-label run-in periods (8 wk on as-needed albuterol; 8 wk on as-needed ipratropium). Five hundred forty-four subjects were randomized by Arg16Gly genotype to salmeterol alone or with fluticasone propionate for 16 weeks. Change from baseline in morning peak expiratory flow was the primary endpoint.

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A randomized, double-blind, cross-over study was conducted to assess the efficacy and safety of fluticasone propionate 1 mg twice daily administered via a pressurized metered dose inhaler (pMDI) containing the new non-chlorofluorocarbon (CFC) propellant (HFA 134a), or the established CFC propellants 11 and 12 in patients with severe asthma. The study comprised a 2-week run-in period followed by two 6-week treatment periods, with no washout period in between. One hundred and nineteen symptomatic adult patients with severe asthma, who were receiving inhaled beclomethasone 2-4 mg day(-1) or equivalent, were randomized to treatment. Patients were randomized to one of two sequence groups (sequence 1: HFA 134a pMDI then CFC pMDI or sequence 2: CFC pMDI then HFA 134a pMDI). The sequence groups differed with respect to mean peak expiratory flow (PEF) at baseline; however, the magnitude of the increase in PEF from baseline during treatment was similar in the two sequence groups. Mean PEF at baseline was 334 l min(-1) in sequence group 1 (HFA 134a-->CFC pMDI) and this increased to 357 l min(-1) and 366 l min(-1) during treatment with the HFA 134a and CFC pMDI, respectively. In sequence group 2 (CFC-->HFA 134a pMDI) mean PEF at baseline was 297 l min(-1) and this increased to 336 l min(-1) and 328 l min(-1) during treatment with the HFA 134a and CFC pMDI, respectively. Based on an overall analysis of the two treatment groups at week 6, equivalence was demonstrated; the mean treatment difference (HFA 134a-CFC pMDI) in morning PEF was 0 l min(-1) (90% confidence interval (CI), for difference between groups: -7, 6 l min(-1)). There was a comparable improvement in secondary efficacy variables, including clinic lung function measurements, in the two treatment groups. The incidence and type of most adverse events were similar in the two treatment groups. There was no difference in the adjusted geometric mean morning serum cortisol levels after treatment with the HFA 134a and CFC pMDI. Therefore, the fluticasone propionate HFA 134a pMDI constitutes a suitable replacement for the established CFC pMDI at a microgram equivalent dose.

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Randomized double-blind placebo-controlled trials involving patients of any age with Crohn's disease in clinical remission as defined by a CDAI < 150 or by the presence of no symptoms or only mild symptoms at the time of entry into the trial. The experimental treatment consisted of oral conventional corticosteroid therapy (excluding budesonide, fluticasone, etc). Clinical disease relapse was used as the outcome measure of interest.

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This is the first comparison of two combination therapies, fluticasone propionate/salmeterol and ipratropium bromide/albuterol (salbutamol), for the treatment of patients with COPD.

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We found no statistically significant differences in fatal or non-fatal serious adverse events in trials in which regular salmeterol was randomly allocated with ICS, in comparison to ICS alone at the same dose. Although 13,447 adults and 1862 children have now been included in trials, the frequency of adverse events is too low and the results are too imprecise to confidently rule out a relative increase in all cause mortality or non-fatal adverse events with salmeterol used in conjunction with ICS. However, the absolute difference between groups in the risk of serious adverse events was very small. We could not determine whether the increase in all cause non-fatal serious adverse events reported in the previous meta-analysis on regular salmeterol alone is abolished by the additional use of regular ICS. We await the results of large ongoing surveillance studies mandated by the FDA to provide more information. There were no asthma-related deaths and few asthma-related serious adverse events. Clinical decisions and information for patients regarding regular use of salmeterol have to take into account the balance between known symptomatic benefits of salmeterol and the degree of uncertainty and concern associated with its potential harmful effects.

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This review summarizes the recent studies on comparative efficacy of once-versus twice-daily administration of ICS, in light of previous reports.

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Prediction of pharmacokinetic (PK) profile for inhaled drugs in humans provides valuable information to aid toxicology safety assessment, evaluate the potential for systemic accumulation on multiple dosing and enable an estimate for the clinical plasma assay requirements. The accuracy in prediction of inhaled human PK profiles for seven inhaled drugs or drug candidates (salmeterol, salbutamol, formoterol, fluticasone propionate, budesonide, CP-325366 and UK-432097) was assessed using rat oratracheal solution and dry powder PK data. The prediction methodology incorporates allometric scaling and mean residence time (MRT) principles with a two compartmental PK approach. Across the range of compounds tested, the prediction of human inhaled maximum concentration (C(max)) and MRT was within 2-fold for 5 of the 7 compounds, providing an accuracy of prediction similar to the current methodologies used to predict human oral C(max) from preclinical data ( De Buck et al. 2007 ). Administering as a dry powder formulation slowed the rat lung absorption rate of the least soluble compound (fluticasone propionate), impacting the prediction of C(max) and MRT. This flags the potential for preclinical studies with dry powder formulations to positively influence predictive accuracy, although further studies with low solubility inhaled drugs are required to confirm this. This study illustrates the value of preclinical assessment of PKs following administration to the lung, and provides a viable means of predicting the human PK profile for inhaled drugs.

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Mometasone furoate is a well tolerated intranasal corticosteroid with minimal systemic activity and an onset of action of < or = 7 hours. It is effective in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis in patients with moderate to severe symptoms.

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We conducted prespecified analyses of data from the FLAME study, which compared once-daily long-acting β2-agonist/long-acting muscarinic antagonist indacaterol/glycopyrronium 110/50 μg with twice-daily long-acting β2-agonist/inhaled corticosteroid salmeterol/fluticasone combination 50/500 μg in patients with ≥1 exacerbation in the preceding year. Subsequent post-hoc analyses were conducted to address further cut-offs and endpoints.

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This study tested the clinical non-inferiority of the fluticasone propionate/salmeterol combination 50/250 μg (FSC) Rotacaps(®)/Rotahaler(®) system, a single unit dose inhaler, with the multi-dose FSC Diskus(®) inhaler in adults with chronic obstructive pulmonary disease (COPD).

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flonase otc generic 2017-11-30

This was a double-blind, randomized, placebo-controlled, parallel group study. Subjects aged 12-17 years, with mild-to-moderate asthma, intermittent allergic rhinitis and ≥ 10% fall in buy flonase online FEV(1) at a screening exercise challenge were randomized to 22 ± 3 days treatment with intranasal fluticasone furoate or placebo. The primary outcome was change in exercise induced fall in FEV(1) . Secondary outcomes were changes in the area under the curve (AUC), asthma control questionnaire (ACQ), pediatric asthma quality of life questionnaire (PAQLQ), and exhaled nitric oxide (FeNO).

flonase otc cost 2016-12-16

This open-label, randomized study was performed in adults undergoing whole lung or lobar resection resulting from lung cancer. Patients buy flonase online were given single 1000-mug doses of both budesonide and fluticasone propionate via dry powder inhalers before surgery. Tissue samples from peripheral and central lung, an ex vivo bronchial brush sample and intercostal muscle, together with plasma samples, were taken during surgery and analysed by liquid chromatography plus tandem mass spectrometry.

flonase adult dosage 2016-10-16

Otitis media with buy flonase online effusion (OME) is a common childhood disease that is characterized by an accumulation of fluid in the middle ear. Chronic OME can also lead to sensorineural hearing loss (SNHL). Nitric oxide (NO), an inflammatory mediator (IM) of OME, is a free radical known to regulate cell proliferation, cell death, and angiogenesis. Previous studies have shown that nitric oxide may cause SNHL through outer hair cell (OHC) cytotoxicity. This experiment was designed to determine whether glucocorticoids, dexamethasone, fluticasone propionate, or rimexolone, can reduce the concentration of NO in middle ear effusion (MEE).

flonase usual dosage 2015-11-26

Eligible studies were selected by 4 reviewers and data were extracted onto standardized data extraction forms. Disagreements in eligibility or data extraction were resolved by consensus. Data were converted into individual 2x2 tables for each study. The presence of significant heterogeneity among studies was tested using the chi- buy flonase online square test. The 2x2 tables were synthesized into a summary test statistic using the pooled odds ratio and 95% confidence intervals as described by Cochran and Mantel and Haenszel (the 'odds ratio' in MetaView). A fixed effects model was used for the pooling of data.

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We found no clinically significant increase in mean IOP in patients with well-controlled open-angle glaucoma and ocular hypertension after 6 weeks of twice-daily inhaled fluticasone propionate compared with inhaled placebo. No participants exceeded their individualized target IOP. buy flonase online There were no differences in secondary outcomes.

flonase positive reviews 2016-01-01

Fluticasone propionate (FP) is a new topical corticosteroid spray for the treatment of allergic rhinitis and asthma. FP has been shown to be effective for the treatment of adult and pediatric asthma, even at rather low doses (25 microg twice daily [b.i.d.]); many studies in buy flonase online asthma have shown clinical efficacy of fluticasone at half the dose of the comparison steroid (such as beclomethasone dipropionate [BDP] or budesonide [BUD]). However, exact dose comparisons cannot be made because dose-ranging comparison studies have not been done. Studies in allergic rhinitis in children and adults have shown good efficacy in FP-treated patients at a dose of 200 microg once daily (o.d.), intranasally. In summary, FP is effective in both asthma and allergic rhinitis.

flonase max dose 2015-05-23

The nasal score of the mini RQLQ, the number of nasal inflammatory cells (neutrophils, eosinophils) and the number of goblet cells are significantly higher in untreated patients with persistent NAR compared with control subjects and treated NAR patients. The percentage of MUC5AC+ nasal epithelial cells is significantly increased in untreated patients with persistent NAR compared with the control subjects (41.8 ± 6.4 vs 22.3 ± 4.8, respectively; p = 0.0403) without significant differences between control subjects and patients with persistent NAR on regular fluticasone furoate treatment (33.9 ± 5.0 %; p = 0.0604) nor between the 2 groups of persistent NAR subjects (p = 0.3260). The number buy flonase online of cytosolic and/or nuclear p65+ nasal epithelial and inflammatory cells was not significantly different between the three groups.

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Combination therapy is associated with improvements in small airways function in COPD, despite an absence of change in FEV1. FOT may be a clinically useful marker of small airway buy flonase online function in COPD that is responsive to treatment.

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The more favorable risk-benefit ratio of fluticasone indicates that this agent is preferable to beclomethasone for the long-term treatment of children buy flonase online with asthma, especially if moderate doses are required.

flonase user reviews 2015-08-21 (identifier NCT01110200). This study was funded by GlaxoSmithKline (study number ADC113874). buy flonase online

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To document previously buy flonase online unreported acute effects of adrenal insufficiency.

flonase pediatric dosing 2016-03-31

FP (200 microg once daily) affords a significant degree of improvement in rhinitis control during pollen season, as measured by subjective and objective parameters, compared with LEV (200 microg twice daily) buy flonase online and PLA. The therapeutic benefits of intranasal FP are reflected in, and may be caused by, the decrease in nasal inflammatory cells.

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Three clusters were identified, including two groups that benefit from FF/VI versus VI: patients with blood eosinophils >2.4% (RR=0.68, 95% CI 0.58 to 0.79), or blood eosinophils ≤2.4% and smoking history ≤46 pack-years, experienced a reduced rate of exacerbations with FF/VI versus VI (RR=0.78, 95% CI 0.63 to 0.96), whereas those with blood eosinophils ≤2.4% and smoking history >46 pack-years were identified as non-responders (RR=1.22, 95% CI 0.94 to 1.58). Clusters of patients previously identified Atarax And Alcohol in the fluticasone propionate/salmeterol (SAL) versus SAL trials of similar design were not validated; all clusters of patients tended to benefit from FF/VI versus VI alone irrespective of diuretic use and reversibility.

flonase kids dose 2015-10-17

Frequencies of Vα7.2(+)CD161(+) MAIT cells, surface expression of the major histocompatibility complex-related protein 1 (MR1), and intracellular IFN-γ expression were measured by flow cytometry. MAIT-cell frequencies were reduced in peripheral blood of ICS-treated subjects with COPD (median 0.38%; interquartile range [IQR], 0.25-0.96) compared with healthy control subjects (1.8%; IQR, 1.4-2.5; P = 0.001) or steroid-naive patients with COPD (1.8%; IQR, 1.2-2.3; P = 0.04 Buspar Online ). MAIT cells were reduced in bronchial biopsies from subjects with COPD treated with steroids (0.73%; IQR, 0.46-1.3) compared with healthy control subjects (4.0%; IQR, 1.6-5.0; P = 0.02). Coculture of live NTHi increased macrophage surface expression of MR1 and induced IFN-γ from CD4 cells and CD8 cells, but most potently from MAIT cells (median IFN-γ-positive frequencies, 2.9, 8.6, and 27.6%, respectively). In vitro fluticasone and budesonide reduced MR1 surface expression twofold and decreased NTHi-induced IFN-γ secretion eightfold.

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The Parlodel Pills purpose of this investigation was to compare the relative beneficial and systemic effects in a dose-response relationship for 2 ICSs.

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Our study cohort comprised 734 children with asthma (mean Moduretic Maximum Dose age, 8.8±4.3 years) and was predominantly male (61%) and non-Hispanic white (53%). More than one-half of the children (56%; n=413) were receiving an inhaled glucocorticoid daily, with FP the most frequently prescribed agent (65%). Among the children receiving daily FP, single nucleotide polymorphisms in CYP3A5 and CYP3A7 were not associated with asthma control scores. In contrast, asthma control scores were significantly improved in the 20 children (7%) with the CYP3A4*22 allele (median, 3; range, 0-6) compared with the 201 children without the CYP3A4*22 allele (median, 4; range, 0-15; P=.02). The presence of CYP3A4*22 was associated with improved asthma control scores by 2.1 points (95% CI, 0.5-3.8).

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To assess the impact of omalizumab as an add-on therapy to standard treatment with inhaled corticosteroids (ICS) and long-acting beta-2 agonists Levaquin Related Drugs (LABA) on asthma-related quality of life (QoL) in patients with severe allergic asthma.

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Ten percent of children who received prescription medications and 4.9% of all children received >or=1 free drug sample in 2004. In bivariate analyses, poor children (family incomes of <200% of the federal poverty level) were no more likely to receive free samples than were those with incomes of >or=400% of the Diflucan Maintenance Dose poverty level (3.8% vs 5.9%). Children who were uninsured for part or all of the year were no more likely to receive free samples than were those who were insured all year (4.5% vs 5.1%); 84.3% of all sample recipients were insured. In multivariate analyses, routine access to health care (>or=3 provider visits in 2004) was associated with free sample receipt. The 15 most frequently distributed pediatric free samples in 2004 included 2 schedule II controlled medication, Adderall (amphetamine/dextroamphetamine) [corrected] and 4 medications that received new or revised black box warnings between 2004 and 2007, Elidel (pimecrolimus), Advair (fluticasone/salmeterol), Strattera (atomoxetine), and Adderall (amphetamine/dextroamphetamine).

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For mean responses, both doses of BEC-HFA and FLU-HFA produced significant improvements in PD(20) compared with baseline. The improvement was not significantly greater with 1000 micro g/day FLU-HFA versus BEC-HFA, a 1.69 fold difference Norvasc Medication Uses (95% CI 0.94 to 3.04). Both doses of BEC-HFA but not FLU-HFA caused significant suppression of OUCC compared with baseline, with significantly (p<0.05) lower values at 1000 micro g/day for BEC-HFA versus FLU-HFA (1.97 fold difference (95% CI 1.28 to 3.02)).

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The study is a prospective, cluster randomised, parallel-group, multi-site study conducted over 6 months. The study is designed to compare current best practice in care (i.e. routine inhaler technique training) with the use Clomid Dose Ovulation of the INCA® device for respiratory patients in a community pharmacy setting. Pharmacies are the unit of randomisation and on enrolment to the study they will be allocated by the lead researcher to one of the three study groups (intervention, comparator or control groups) using a computer-generated list of random numbers. Given the nature of the intervention neither pharmacists nor participants can be blinded. The intervention group will receive feedback from the acoustic recording device on inhaler technique and adherence three times over a 6-month period along with inhaler technique training at each of these times. The comparator group will also receive training in inhaler use three times over the 6-month study period but no feedback on their habitual performance. The control group will receive usual care (i.e. the safe supply of medicines and advice on their use). The primary outcome is the rate of participant adherence to their inhaled medication, defined as the proportion of correctly taken doses of medication at the correct time relative to the prescribed interval. Secondary outcomes include exacerbation rates and quality of life measures. Differences in the timing and technique of inhaler use as altered by the interventions will also be assessed. Data will be analysed on an intention-to-treat and a per-protocol basis. Sample size has been calculated with reference to comparisons to be made between the intervention and comparator clusters and indicates 75 participants per cluster. With an estimated 10 % loss to follow-up we will be able to show a 20 % difference between the population means of the intervention and comparator groups with a power of 0.8. The Type I error probability associated with the test of the null hypothesis is 0.05.

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FFNS has a favourable safety and tolerability profile in patients aged 6-11 years with PAR or SAR.

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BDP/F extra-fine combination is effective in reducing air trapping and dyspnea in COPD patients with lung hyperinflation.

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After three consecutive weekly visits, 86 patients were randomised to receive either fluticasone 500 mug twice daily (n = 43, 23F, mean (SD) age 57.7 (14.4) years) or matched placebo (n = 43, 34F, 59.2 (14.2) years) and reviewed regularly for 52 weeks in a double blind fashion.

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OPN expression was detected in epithelial cells, subepithelial infiltrating/inflammatory cells and cells lining the vessels and glands of all subjects. Comparison of the pre- and peak-pollen season biopsy sections in placebo treated patients revealed no increase in OPN expression during the grass pollen season (5.7% vs 6.4%). Treatment with a local glucocorticosteroid did not alter the expression of OPN during pollen exposure (6.2% vs 6.7%).

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Patients aged ≥12 years were evenly randomized to 12 weeks of treatment with fluticasone/formoterol (100/10 µg BID), fluticasone (100 µg BID), or formoterol (10 µg BID), in this multicenter, double-blind, parallel-group, study. The 2 coprimary end points were: (1) change in forced expiratory volume in 1 second (FEV(1)) from morning predose at baseline to predose at week 12 for the comparison of the combination product with formoterol alone; and (2) change in FEV(1) from morning predose at baseline to 2 hours postdose at week 12 for the comparison of the combination product with fluticasone alone. The secondary objective was to demonstrate the efficacy of fluticasone/formoterol using other pulmonary function tests and clinical end points. Tolerability was assessed based on adverse events, clinical laboratory tests and vital sign evaluations.

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Across the studies, a range of drugs and doses were used. For ICS, six studies administered budesonide (dose range: 0.4-2 mg), and three studies gave fluticasone/flunisolide (dose range: 0.5-2 mg). Six studies administered oral prednisone (dose range: 1-2 mg/kg/day), and four studies gave placebo. The rate of hospital admissions in patients treated with ICS was not significantly higher than those treated with oral SC. The rate of hospital admissions in patients treated with ICS was significantly lower than those treated with placebo.

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Morning cortisol levels were monitored after patients had been on fluticasone for a mean of 8.0 +/- 5.2 months. Patients who had abnormal low morning cortisol levels (<5.5 microg/dL) were then switched either to lower fluticasone dosage or to other inhaled steroid formulation. Exact methods based on the binomial distribution were used to construct a 95% confidence interval for the true proportion of abnormal readings among those treated, and the Wilcoxon signed rank test was used to test for a significant difference between cortisol levels taken before and after the switch.

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Direct treatment costs were retrospectively applied to 2 prospective randomised parallel group clinical trials conducted in Germany comparing fluticasone propionate and flunisolide: one 6-week open-label study (n = 332) and one 8-week double-blind study (n = 308) in corticosteroid-naive patients with asthma of moderate severity aged between 18 and 70 years. All costs were adjusted to 1997 Deutschmarks. Efficacy parameters included changes in morning and evening peak expiratory flow rate (PEFR) measurements, the number of successfully treated patients (defined as those with a PEFR improvement of > or = 10%) and proportion of symptom-free days.

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We wanted to evaluate the improvement in efficacy when increasing the daily dose of inhaled steroids and to compare the efficacy, safety, and tolerance of 1.6 mg beclomethasone dipropionate (BDP) with that of 2.0 mg fluticasone propionate (FP). The study was a randomized, double-blind, 3 month, multicentre study. One hundred and thirty four asthmatics currently using inhaled steroids (0.4-1.6 mg BDP or budesonide (BUD)) were stratified according to pretrial daily steroid use. Within each stratum they were randomized to either 1.6 mg BDP or 2.0 mg FP. A significant increase in the primary efficacy variables, i.e. mean morning and evening peak expiratory flow (PEF) (approximately 20 l.min-1) during the treatment period, was found for both treatments. No significant differences between the drugs were revealed for these primary or any other secondary efficacy variables (use of beta 2-agonists, symptom scores, and PEF, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) recorded at the clinical visits). However, significant differences between treatments occurred regarding decrease of serum cortisol and adrenocorticotropic hormone. We conclude that, although both treatments gave statistically significant increases in efficacy parameters when compared with baseline, the increases were so small that they can be regarded as being clinically unimportant. Daily doses of BDP, 1.6 mg, and FP, 2.0 mg, had comparable effects on lung function. A suppression of the hypothalamic pituitary adrenal (HPA) axis was only found with a daily dose of 2 mg FP.