Efficacy and safety of beclomethasone dipropionate nasal aerosol in children with perennial allergic rhinitis.
Ann Allergy Asthma Immunol
; 115(2): 130-6, 2015 Aug.
Article
em En
| MEDLINE
| ID: mdl-26115578
ABSTRACT
BACKGROUND:
Beclomethasone dipropionate (BDP) nasal aerosol (non-aqueous) is approved for management of seasonal and perennial allergic rhinitis (PAR) in adolescents and adults.OBJECTIVE:
To evaluate the efficacy and safety of BDP nasal aerosol at 80 µg/day in children with PAR.METHODS:
This 12-week, phase 3, double-blinded, placebo-controlled, parallel-group study randomized 547 children (4-11 years old) with PAR to once-daily BDP nasal aerosol at 80 µg/day or placebo. The primary end point was change from baseline in average morning and evening reflective total nasal symptom score (rTNSS) during the first 6 weeks of treatment in patients 6 to 11 years old. Changes from baseline in average morning and evening instantaneous TNSS (iTNSS) in children 6 to 11 years old and average rTNSS and iTNSS in children 4 to 11 years old were assessed during the first 6 weeks of treatment.RESULTS:
Improvements were significantly greater with BDP nasal aerosol than with placebo during the first 6 weeks of treatment in children 6 to 11 years old in average morning and evening rTNSS and iTNSS (mean treatment difference -0.66 [P = .002] and -0.58 [P = .004], respectively). Improvements in average morning and evening rTNSS and iTNSS also were significantly greater in patients 4 to 11 years receiving BDP nasal aerosol than with placebo during the first 6 weeks of treatment (P = .002 and P = .004, respectively). Similar improvements were seen during 12 weeks of treatment. The safety profile of BDP nasal aerosol was comparable to that of placebo.CONCLUSION:
The BDP nasal aerosol at 80 µg/day in children 4 to 11 years old was well tolerated and effective in controlling nasal symptoms of PAR. TRIAL REGISTRATION www.clinicaltrials.gov, identifier NCT01783548.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Beclometasona
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Rinite Alérgica Perene
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Antialérgicos
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Child
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Child, preschool
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article