Recombinant human DNase nebulisation in children with cystic fibrosis: before bedtime or after waking up?

Abstract

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 endpoint was classified as the maximal instantaneous forced flow when 25% of the forced vital capacity remained to be exhaled (MEF25%). 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. MEF25%, 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.

Characterization of the laminin gene family and evolution in zebrafish

“…This was a substudy of a randomized controlled cross over trial in which we evaluated effects of administration of rhDNase or a placebo (saline 0.9%) before or after the night during two periods of 2 weeks 22. For this substudy we included the saturation profiles during the 7th and the 14th night in the 2 weeks when placebo was inhaled before the night and rhDNase in the morning.…”

Nocturnal oxygen saturation in children with stable cystic fibrosis

“…This was a substudy of a randomized controlled cross over trial in which we evaluated effects of administration of rhDNase or a placebo (saline 0.9%) before or after the night during two periods of 2 weeks. 22 For this substudy we included the saturation profiles during the 7th and the 14th night in the 2 weeks when placebo was inhaled before the night and rhDNase in the morning. Nebulization of saline 0.9% was assumed not to have major effects on sputum viscosity and the nocturnal saturation profile.…”

Determining presence of lung disease in young children with cystic fibrosis: Lung clearance index, oxygen saturation and cough frequency

“…Cough is an important component of mucociliary clearance [23] and is thought to be more frequent in CF compared to healthy control subjects [24,25]. Cough monitoring has been used in small scale clinical studies [26,27], and can be monitored at home using relatively simple audiometry. It is not known whether nocturnal cough monitoring can be used as a surrogate endpoint in young children.…”