Table 4 Clinical Studies with Levodropropizine vs Central antitussives in Children

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.