Treatment with nasal beclomethasone dipropionate (nBDP) was more effective in improving nasal patency and cytology, sleep quality, and quality of life compared with cetirizine in pediatric patients with perennial allergic rhinitis (PAR), according to a study published by the Journal of Investigational Allergology and Clinical Immunology.
Researchers conducted a 21-day, single-center, open-label, randomized controlled study that included 68 children aged 6 to14 years diagnosed with PAR at a pediatric allergy outpatient clinic in Italy. Children were randomly assigned 1:1 to receive either nBDP 100 µg per nostril twice daily (n=34) or cetirizine 10 mg tablets once daily (n=34).
The purpose of the study was to compare the effect of 21-day treatment with nBDP and cetirizine on nasal patency in children with PAR through changes in acoustic rhinometry parameters (nasal volume and minimal cross-sectional area) from baseline to day 21. Secondary outcomes studied included nasal cytology, nasal symptom severity (Total 5 Symptom Score [T5SS]), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), and quality of life (Paediatric Rhinoconjunctivitis Quality of Life Questionnaire [PRQLQ]).
In total, 65 participants (96%) completed the study. After 21 days, there was a significant increase in volume values in children treated with nBDP (P =.033) but not in children who received cetirizine (P =.900). In addition, there was a significant increase in minimal cross-sectional area for those in the nBDP group but not in the cetirizine group (P =.045 and P =.840, respectively). Even after adjusting for confounders, nBDP was still found to improve the nasal volume and minimal cross-sectional area significantly more than cetirizine in children (least square mean change [LSmc], 2.21 cm3 vs 0.20 cm3, P =.013 and LSmc, 0.63 cm2 s 0.13 cm2; P =.002).
Regarding secondary outcomes, a larger improvement was found in both eosinophil (LSmc, –1.10 vs –0.40; P =.031) and neutrophil (LSmc, –0.97 vs –0.17; P =.010) classes, T5SS total score (LSmc, –5.63 vs –3.54; P =.008), PSQI total score (LSmc, –1.30 vs –0.19; P =.025), and PRQLQ total score (LSmc, –1.15 vs –0.69; P =.031) in children treated with nBPD compared with cetirizine, respectively.
Researchers concluded that nBDP was more effective in improving nasal patency after a 21-day treatment trial compared with cetirizine. Improvements were observed in nasal volume from the first 5 cm from the nostril, as well as in the minimal cross-sectional area, demonstrating the successful anti-inflammatory effect of nBDP. Not only was nBDP successful in improving objective clinical signs, but it also reduced the subjective burden of PAR compared with cetirizine, demonstrated through the improvement of T5SS, PSQI, and PRQLQ scores. Clinicians should consider using nBDP compared with cetirizine when treating PAR in children but should also keep in mind the drug safety profile of nBDP because this study did not evaluate drug safety. However, a recent study that found no significant systemic effects related to treatment with nBDP.
Malizia V, Fasola S, Ferrante G, et al. Comparative effect of beclomethasone dipropionate and cetirizine on acoustic rhinometry parameters in children with perennial allergic rhinitis: a randomized controlled trial [published online April 24, 2018]. J Investig Allergol Clin Imunol. doi:10.18176/jiaci.0263