Lianne J van der Giessen, Johan C de Jongste, Rik Gosselink, Wim CJ Hop, Harm AWM Tiddens
The purpose of this study is to establish the optimal timing of rhDNase nebulisation in accordance with airway clearance by studying the effects of implementing the treatment before and after the airway clearance techniques (ACT).
A randomized, double blind, double dummy, cross over study was designed. Patients were included if they were a CF sufferer and clinically stable, and using rhDNase therapy. Treatment took place over 6 weeks, and the participants were allocated to either group I or II. Group I received rhDNase 30 minutes before ACT, and placebo directly after ACT in week 1-3. The protocol was reversed during week 4-6. Group II performed the reversed sequence, All patients continued their routine ACT.
Pulmonary functions tests were performed on days 0, 14, 21, 35 and 42. In weeks 3 and 6 children scored cough and sputum production on daily diary cards. 24 patients in total completed the study. Primary endpoint: MEF25 %pred. Following 3 weeks of rhDNase before ACT, Mean MEF25 %pred had raised by 5.8% in comparison to rhDNase following ACT.
The results show that rhDNase prior to ACT improves peripheral airway patency in children with cystic fibrosis. Also, as all subjects were on maintenance therapy prior to taking part in the study, this effect is in addition to existing effects of the therapy.
Pediatric Pulmonology, 2007, 42, 624-630