The present study focused on patients with
cystic fibrosis (CF), who were on maintenance
therapy with recombinant human
deoxyribonuclease (
rhDNase), with the aim of comparing efficacy and possible side effects of nebulisation of
rhDNase when taken before bedtime with efficacy and side effects when taken after waking up. A randomised, double-blind, double-dummy, crossover study group was used. The inclusion criteria were as follows: 1) CF, 2) stable clinical condition and 3)
rhDNase maintenance
therapy. Patients in group I inhaled
rhDNase before bedtime and a placebo after waking up in weeks 1-2. The protocol was reversed during weeks 3-4. Group II patients performed the reverse of this sequence. Patients continued with their daily routine sputum expectoration. The primary end-point was classified as the maximal instantaneous forced flow when 25% of the forced vital capacity remained to be exhaled (MEF(25%)). Pulmonary functions tests were performed on days 0, 7, 14, 21 and 28. At 1, 2, 3 and 4 weeks arterial oxygen saturation and
cough frequency were measured during the night. A total of 24 patients completed the study. The mean (range) age of the patients was 13 (6-19) yrs. MEF(25%), taken to be the primary end-point, did not show a significant difference between nebulisation of
rhDNase before bedtime compared with when taken after waking up. Nocturnal
cough, oxygen saturation, and other secondary end-points were not significantly different between the two study periods. In conclusion, the present study found that it is equally effective and safe to nebulise recombinant human
deoxyribonuclease before bedtime compared with when performed after waking up in children with
cystic fibrosis, who are on maintenance treatment with recombinant human
deoxyribonuclease.