Fluticasone Propionate In Children Research Articles

Analysis of the Therapeutic Effect of Pidotimod Assisted Fluticasone Propionate in Children with Asthma and their Immune Function

Analysis of the Therapeutic Effect of Pidotimod Assisted Fluticasone Propionate in Children with Asthma and their Immune Function

Safety of a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in children: A randomized clinical trial.

The safety of a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) has been established in adults and adolescents with allergic rhinitis but not in children <12 years old. To evaluate the safety and tolerability of an intranasal formulation of AZE and FP in children ages 4-11 years with allergic rhinitis. The study was a randomized, 3-month, parallel-group, open-label design. Qualified patients were randomized in a 3:1 ratio to AZE/FP (n = 304) or fluticasone propionate (FP) (n = 101), one spray per nostril twice daily, and to one of three age groups: ≥4 to <6 years, ≥6 to <9 years, and ≥9 to <12 years. Safety was assessed by child- or caregiver-reported adverse events, nasal examinations, vital signs, and laboratory assessments. The incidence of treatment-related adverse events (TRAEs) was low in both the AZE/FP (16%) and FP-only (12%) groups after 90 days' continuous use. Epistaxis was the most frequently reported TRAE in both groups (AZE/FP, 9%; FP, 9%), followed by headache (AZE/FP, 3%; FP, 1%). All other TRAEs in the AZE/FP group were reported by ≤1% of the children. The majority of TRAEs were of mild intensity and resolved spontaneously. Results of nasal examinations showed an improvement over time in both groups, with no cases of mucosal ulceration or nasal septal perforation. There were no unusual or unexpected changes in laboratory parameters or vital signs. The intranasal formulation of AZE and FP was safe and well tolerated after 3 months' continuous use in children with allergic rhinitis.The study was registered on <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> (NCT01794741).

Efficacy Analysis of MP-AzeFlu Compared with Fluticasone Propionate Nasal Spray in Children 6 through 11 Years of Age with Allergic Rhinitis

MP-AzeFlu (Dymista®) is a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) for treatment of allergic rhinitis. The objective of the current analysis was to evaluate the efficacy of MP-AzeFlu compared to FP administered 1 spray per nostril twice daily in children 6 through 11 years of age. This was a randomized, open-label, 3-month safety study in patients 4 through 11 years of age. Qualified patients had a history of AR, were in good health, and had no evidence of nasal mucosal erosion, nasal ulceration, nasal septum perforation, or any significant nasal disease. Randomization was in a 3:1 ratio (MP-AzeFlu [n=304]:FP [n=101]). Efficacy was not a pre-specified study objective but was evaluated by self-assessment of overall allergy symptom severity in a subset of patients 6 through 11 years (MP-AzeFlu [n=264]:[FP: n=89]). Symptom severity was scored on a 4-point scale from 0 to 3 (0 = none; 1 = mild; 2 = moderate; 3 = severe). Total symptom score at baseline was 1.73 in the MP-AzeFlu group and 1.80 in the FP group (max score: 3). Over the entire study period, patients treated with MP-AzeFlu experienced a -0.68 pt reduction in overall symptom score (corresponding to a -5.44 change from baseline in AM + PM reflective total nasal symptom score (rTNSS; max = 24), significantly greater relief than that afforded by FP (-0.54 pt reduction; Diff: -0.14; 95% CI: -0.28, -0.01; p=0.04). MP-AzeFlu provided significantly greater relief of AR symptoms than FP in children 6 through 11 years of age.

Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma

BackgroundLong-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children.MethodsWe randomly assigned, in a 1:1 ratio, children 4 to 11 years of age who required daily asthma medications and had a history of asthma exacerbations in the previous year to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization), as assessed in a time-to-event analysis. The statistical design specified that noninferiority would be shown if the upper boundary of the 95% confidence interval of the hazard ratio for the primary safety end point was less than 2.675. The main efficacy end point was the first severe asthma exacerbation that led to treatment with systemic glucocorticoids, as assessed in a time-to-event analysis.ResultsAmong the 6208 patients, 27 patients in the fluticasone–salmeterol group and 21 in the fluticasone-alone group had a serious asthma-related event (all were hospitalizations); the hazard ratio with fluticasone–salmeterol versus fluticasone alone was 1.28 (95% confidence interval [CI], 0.73 to 2.27), which showed the noninferiority of fluticasone–salmeterol (P=0.006). A total of 265 patients (8.5%) in the fluticasone–salmeterol group and 309 (10.0%) in the fluticasone-alone group had a severe asthma exacerbation (hazard ratio, 0.86; 95% CI, 0.73 to 1.01).ConclusionsIn this trial involving children with asthma, salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone. (Funded by GlaxoSmithKline; VESTRI ClinicalTrials.gov number, NCT01462344.)

Effect of delivery device on systemic exposure to inhaled fluticasone propionate in children with asthma

Effect of delivery device on systemic exposure to inhaled fluticasone propionate in children with asthma

Effect of addition of salmeterol versus doubling the dose of fluticasone propionate on specific airway resistance in children with asthma

Based primarily on extrapolation from adult studies, current pediatric asthma guidelines advise the addition of long-acting beta₂-agonists for children symptomatic on low/moderate-dose inhaled corticosteroids before increasing the corticosteroid dose. This study was designed to compare the effect of combination salmeterol/fluticasone propionate (SFC) with doubling the dose of fluticasone propionate (FP) on specific airway resistance (sR(aw)) in moderate/severe persistent asthmatic children. A double-blind, randomized, controlled study was performed; children with asthma (4-11 years old; sR(aw) > 1.3 kPa·s) were randomized after a 2-week run-in (FP, 100 μg, b.i.d.) to either SFC (50 μg/100 μg b.i.d.) or FP (200 μg b.i.d.) via Diskus (GlaxoSmithKline, Stockley Park, U.K.) for 6 weeks. Lung function (sR(aw)-plethysmography and forced expiratory volume in 1 second [FEV₁]) was measured before run-in, at randomization, after 3 weeks, at the end of 6-week treatment, and after 48-hour washout. Symptom scores and rescue medication use were recorded throughout. Thirty-five children entered run-in and 24 were randomized (mean age, 7.3 ± 2.2 years; 50% boys). All children showed an improvement in sR(aw). After adjusting for age, gender, and baseline sR(aw,) children receiving SFC had a significantly greater improvement in sR(aw) compared with those receiving FP (adjusted means ratio [95% confidence interval {CI}], 0.81 [0.68-0.97]; p = 0.021). There was a significant interaction between treatment and gender (sR(aw), adjusted geometric mean [95% CI ]kPa·s, SFC versus FP: boys, 1.25 [1.10-1.41] [n = 7] versus 1.87 [1.61-2.17] [n = 5]; girls, 1.29 [1.10-1.52] [n = 5] versus 1.29 [1.13-1.47] [n = 7]; p = 0.008). There were no differences in FEV₁, symptoms, or rescue medication use between the groups. Addition of salmeterol provides greater improvement in sR(aw) than doubling the dose of FP in children with moderate/severe persistent asthma.

Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma

Background Ciclesonide is a new inhaled corticosteroid (ICS). Information about its clinical efficacy and safety in relation to other ICS in children is needed for clinical positioning. Objective This 12-week, randomized, double-blind, double-dummy, three-arm, parallel-group study compared the efficacy and safety of ciclesonide with fluticasone propionate in children with mainly moderate and severe persistent asthma. Methods Seven hundred and forty-four patients (aged 6–11 years) were randomized to ciclesonide (80 or 160 μg once daily) or fluticasone propionate (88 μg twice daily), following a 2–4-week run-in. Efficacy measurements included forced expiratory flow in 1 s (FEV 1), morning peak expiratory flow (PEF), asthma symptom scores, rescue medication use and quality of life. Systemic effect was assessed by 24-hour urine free cortisol adjusted for creatinine. Results FEV 1 and morning PEF increased from baseline in all groups ( p < 0.0001). Ciclesonide 160 μg was not inferior to fluticasone propionate 176 μg for FEV 1 ( p = 0.0030, one-sided). In all groups, asthma symptom score sums and rescue medication use significantly improved ( p < 0.0001). The percentages of asthma symptom-, rescue medication- and nocturnal awakening-free days were high, with no significant differences between treatments. Quality of life scores improved with all treatments ( p < 0.0001). A significant dose–response occurred between low and higher doses of ciclesonide for exacerbations and asthma control definitions. The incidences of adverse events were comparable across treatments. Urine free cortisol levels decreased significantly with fluticasone propionate ( p = 0.0103), but not with ciclesonide. Conclusion Once-daily ciclesonide has a clinical effect similar to that of fluticasone propionate, but does not suppress cortisol excretion, in children with moderate and severe asthma.

Comparison of add-on therapy to inhaled fluticasone propionate in children with asthma: Residual volume and exhaled nitric oxide as outcome measures

The purpose of this study was to evaluate changes in lung function and fractional exhaled nitric oxide (FeNO) in children with mild to moderate persistent asthma treated with low-dose inhaled steroids but still manifesting significantly increased residual volume (RV). This was a crossover study evaluating lung function and FeNO before and after a 2-week crossover therapy period by adding either montelukast or salmeterol to inhaled fluticasone propionate in 12 children with asthma. Salmeterol increased forced expiratory volume at 1 second (FEV(1)) and decreased RV without effects on eNO. Addition of montelukast produced a statistically significant decrease both for RV (from 191.7 +/- 60.8% to 132.4 +/- 36.1%; p = 0.03) and for eNO (from 14.0 +/- 6.3 ppb to 8. 5+/- 5.0 ppb; p < 0.01). No effect was observed for the montelukast treatment period in FEV(1) and forced expiratory flow at 25-75%. Add-on therapy may reduce RV and decrease levels of FeNO, leading to consideration of a possible anti-inflammatory additive effect that could improve the control of the disease.

Behavioural changes with fluticasone propionate in children

Behavioural changes with fluticasone propionate in children

A comparison of the relative growth velocities with budesonide and fluticasone propionate in children with asthma

There have been no previous large, well-designed direct comparisons of the effects of fluticasone propionate (FP) and budesonide (BUD) on growth in children. This randomised, double-blind study compared the effects on growth of FP and BUD in children aged 6-9 years with persistent asthma. Following a 6-month run-in period (without inhaled corticosteroids), patients with normal growth velocity were randomised to 12 months' treatment with FP 100 micro g bd (n=114) or BUD 200 micro g bd (n=119). Growth velocity was determined by stadiometric height measurement. Lung function, asthma symptoms and use of relief medication were also assessed. Annualised mean growth velocity during run-in was comparable in the two groups (FP: 5.9 cm/yr; BUD: 6.0 cm/yr). During the treatment period, adjusted mean growth velocity was significantly higher in the FP than the BUD group (5.5 cm/yr vs 4.6 cm/yr; P<0.001). Asthma control improved similarly in both treatment groups. Bone mineral density and overnight urinary cortisol:creatinine ratios were similar in the two groups. Drug-related adverse events were reported among 3% of FP-treated children, compared with 2% for BUD. In conclusion, this study demonstrates that FP for childhood asthma has significantly less impact on childhood growth velocity than a therapeutically equivalent dose of BUD.

Effects of Inhaled Fluticasone Propionate in Children Less Than 2 Years Old With Recurrent Wheezing

Teper AM, Colom AJ, Kofman CD, Maffey AF, Vidaurreta SM, Bergada I. Pediatr Pulmonol . 2004;37:111–115 To evaluate the efficacy and safety of inhaled fluticasone propionate in children <2 years old with a history of recurrent wheezing and risk factors for asthma persisting into late childhood. Subjects were 30 children, aged 7 to 24 months, with ≥3 episodes of wheeze responsive to bronchodilators and a family history of asthma, allergic rhinitis, or eczema. In this double-blind study, subjects were randomized to receive either inhaled 50 μg of fluticasone twice daily, 125 μg of fluticasone twice daily, or placebo for …

Adrenal suppression from high-dose inhaled fluticasone propionate in children with asthma.

This cross-sectional study was designed to examine the prevalence of adrenocortical suppression in children with asthma treated with high-dose inhaled fluticasone propionate (FP). Children and adolescents (n=50) with asthma, treated with inhaled FP at a dose of > or = 1,000 mg a day for > or = 6 months, were enrolled. Early morning serum cortisol was performed. Subjects with a serum cortisol of < 400 nmol x L(-1) had a tetracosactrin stimulation test. Fifty subjects of mean age 13.1 yrs were treated with a mean dose of 924.7 microg x m(-2) x day(-1) FP for a mean duration of 2 yrs. Of the 50 subjects, 36 (72%) had serum cortisol levels of < 400 nmol x L(-1) and underwent tetracosactrin stimulation test. Of these, 6 (17%) demonstrated a less than two-fold increase in serum cortisol from baseline and peak cortisol level of < or = 550 nmol x L(-1) at 30 or 60 min poststimulation. There was a significant negative correlation between the dose of FP x m(-2) and stimulated peak cortisol level. Biochemical evidence of adrenocortical insufficiency was demonstrated in 12% of the subjects, indicating that high-dose fluticasone propionate use may be associated with dose-dependent adrenocortical suppression.

Efficacy and safety of dry powder fluticasone propionate in children with persistent asthma

Flovent Diskus is a powder formulation of the inhaled corticosteroid fluticasone propionate (FP) delivered via a breath-actuated, multidose inhaler. To determine the efficacy and safety of dry powder FP administered once or twice daily (200 microg per day) to children with persistent asthma. Twelve-week, randomized, double-blind, placebo-controlled, multicenter trial with a 52-week, open-label extension. Children aged 4 to 11 were required to have pulmonary function 50% to 85% of predicted values. The population was stratified for baseline therapy (inhaled corticosteroid/cromolyn or bronchodilators only). After a 2-week placebo run-in, 242 patients received dry powder FP 200 microg each morning, dry powder FP 100 microg BID, or placebo for 12 weeks; 192 were rerandomized to the QD or BID regimen for an additional 52 weeks of open-label treatment. Primary endpoints were mean changes in FEV1 and morning PEF recorded at clinic visits. Both dry powder FP regimens significantly improved FEV1, evening PEF, and asthma symptoms at the double-blind phase endpoint (P < or = .017 compared with placebo). The BID regimen also significantly improved morning PEF and nighttime awakenings due to asthma (P < or = .005). Among patients previously treated with inhaled corticosteroids/cromolyn, improvements observed with the QD and BID regimens were similar. Patients switched from BID to open-label QD treatment showed additional improvements at week 52 generally comparable to patients who received the BID regimen during both phases. Fluticasone propionate was well tolerated for up to 64 weeks with few reports of drug-related adverse events or morning plasma cortisol abnormalities. Once daily dosing of dry powder FP 200 microg is an effective and convenient alternative for children whose asthma is controlled with a more frequent dosing regimen of inhaled corticosteroids.

Oral-steroid sparing effect of inhaled fluticasone propionate in children with steroid-dependent asthma

To evaluate the oral steroid-sparing effect of inhaled fluticasone propionate (FP) in eight children with steroid-dependent asthma. Treatment protocol study at a tertiary pulmonary care centre at a children's hospital. Eight children with severe persistent steroid dependent asthma (mean age 11.6 years [range 10 to 13 years], mean duration of asthma 8.37 years [range three to 11 years]) were enrolled in the study. Inhaled FP 880 mug/day (two puffs of 220 mug/puff, two times a day) was added to the children's asthma treatment, and attempts were made to reduce the dose of oral steroids by 20% every two weeks over a six-month period. After this six-month period, in the patients responding to inhaled FP, the dose of inhaled FP was reduced to 440 mug/day (two puffs of 110 mug/puff, two times a day) for the next six months. The mean percentage predicted values for forced expiratory volume in 1 s (FEV(1)) and maximal mid-expiratory flow rate (FEF(25%-75%)) were compared during the first month, at two to six months, and at seven to 12 month intervals before and after starting FP. The number of asthma exacerbations, emergency room visits, hospital admissions and number of school days lost were also compared. Within three months of starting inhaled FP, the mean alternate-day oral steroid dose decreased from 38 mg to 2.5 mg. In addition, six patients (66%) were able to discontinue the use of oral steroids. There was significant improvement in the number of mean emergency room visits per patient (P=0.016), mean asthma exacerbations per patient (P=0.016), mean hospital admissions per patient (P=0.016) and mean number of school days lost per patient (P=0.004) while patients were receiving high dose inhaled FP compared with oral steroids. There was no deterioration of any of the above mentioned parameters during the six month period when the dose of inhaled FP was reduced. The mean FEV(1) and FEF(25%-75%) during the two- to six-month and seven- to 12-month periods showed significant improvement, while the patients were receiving FP compared with oral steroids (P<0.05 for both parameters for both time periods). High dose inhaled FP 880 mug/day has an important oral steroid-sparing effect. After oral steroids are tapered, patients maintain adequate control of asthma with low dose inhaled FP. These findings suggest that FP may control asthma better than oral steroids.

Fluticasone propionate in children

Fluticasone propionate in children