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Table 4 Clinical Studies with Levodropropizine vs Central antitussives in Children

From: Cough management: a practical approach

Study Sample Size Design Disease Results
Banderali et. al J Int Med Res 1995 May-jun;23(3): 175-83 254 children aged between
2 and 14 yrs
Double blind randomized Dropropizine vs
Levodropropizine
Non-Productive Cough There were statistically significant decreases in the frequency of coughing spells and nocturnal awakenings after both LDP and dropropizine treatments with no statistical difference between both group. Somnolence was twice as frequent in the dropropizine group (10.3% vs 5.3%) and the difference is clinically relevant, though not statistically significant.
Dong Soo Kim et al. Diagnosis and Treatment Vol 22. Num 9. 2002 77 children aged 2 and 3 years Double blind randomized LDP vs Dextromethorphan Bronchitis The results show the antitussive effectiveness of LDP and point out a more favourable benefit/risk profile when compared with dextromethorphan.
Fiocchi A et al. Ped Med Chir 1989 70 children, age ranged between 2 months and 14 years Open Label Respiratory tract disease - The treatment was effective on 69/70 children. No child showed a worsening in the cough after 24 hours treatment.
Tamburrano et al. Terapie essenziali in clinica 1989; 3-7 180 children aged between 5 months and 12 years Open Label Respiratory tract disease - The results of the present study prove that the treatment with LDP in children is excellently tolerated and clinically active
Banderali et al Study LPD 0191. Data on file Unplublished 325 children aged between 2 and 14 years Open label Non-productive cough - This study proved the a favourable therapeutic results with limited risk of inefficacy, with the subsequent improvement in the patient's and parents' quality of life, and with remarkably limited risk of intolerance, especially in terms of daytime somnolence.