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

Comparative Efficacy and Safety of Low-dose Fluticasone Propionate and Montelukast in Children with Persistent Asthma

“…FP (50 or 100 mg twice daily) administered over 12 weeks via the DISKUS or Diskhaler dry powder inhalers to 437 children 4 to 11 years of age significantly improved FEV 1 , PEF, b 2 -agonist use, and asthma symptom scores. 10 In this and other 12-week 11,12 or 52-week 32 pediatric studies, FP was well tolerated and demonstrated an acceptable safety profile. When administered with a metered dose inhaler attached to a Volumatic spacer (Volumaticy, Allen & Hanburys, Stockley Park West, UK), FP at daily doses of 200 mg also was shown to significantly decrease exercise-and methacholine-induced bronchoconstriction in children 6 to 14 years of age with mild to moderate asthma.…”

“…This also reflects the severity of patient populations used in the pivotal studies for the two products being evaluated. 10,11,14 FP is an inhaled corticosteroid with high topical potency and limited oral systemic bioavailability that has been demonstrated to be effective in controlling asthma in children with an acceptable safety profile, when used at approved doses. FP (50 or 100 mg twice daily) administered over 12 weeks via the DISKUS or Diskhaler dry powder inhalers to 437 children 4 to 11 years of age significantly improved FEV 1 , PEF, b 2 -agonist use, and asthma symptom scores.…”

“…The leukotriene receptor antagonist, montelukast (MON) (Singulair â , Merck, Whitehouse Station, NJ) is available for treatment of children at dosages of 5 mg once daily for patients 6 to 14 years of age, and 4 mg for patients 1 to 5 years of age. 9 Several clinical trials have demonstrated the efficacy and safety of the inhaled corticosteroid fluticasone propionate (FP) [10][11][12][13] as well as the leukotriene receptor antagonist MON [14][15][16] in the treatment of pediatric asthma. Moreover, comparative studies in adolescents and adults have demonstrated greater efficacy with inhaled steroids versus leukotriene receptor antagonists.…”

Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: The Pediatric Asthma Controller Trial

“…16 Other trials have demonstrated the effectiveness of low-dose fluticasone even administered once daily. [27][28][29][30][31] However, the comparability of PACT combination to twice the ICS dose in achieving our primary study outcomes suggests that the argument is moot and that salmeterol has the potential to allow lower doses of ICS in children with mild-moderate asthma.…”

Allergic rhinitis and asthma in children: Disease management and outcomes

“…At a daily dose of 100 µg twice daily, fluticasone propionate therapy for 12 weeks significantly increased FEV 1 and morning PEF, as well as reducing nocturnal awakenings, from baseline to treatment week 12, as compared with placebo in a study of persistent asthma in 242 children aged 4 to 11 years [30]. These findings extended the results of a prior trial of equal duration, which demonstrated that therapy with either 50 or 100 µg fluticasone twice daily (by multidose dry-powder inhaler) significantly enhanced the same parameters as against baseline in 437 children of similar age [31].…”