RhDNase nebulisation in children with Cystic Fibrosis before bedtime or after waking up?

¹ Dept of Paediatric Physiotherapy, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands
² Dept of Respiratory Rehabilitation, University Hospitals, KU Leuven, Belgium
³ Dept of Epidemiology & Biostatistics, Erasmus MC, Rotterdam, the Netherlands
⁴ Dept of Paediatrics - Respiratory Medicine and Allergology, Erasmus MC - Sophia Children's Hospital Rotterdam, the Netherlands

^* To whom correspondence should be addressed. E-mail: L.vandergiessen{at}erasmusmc.nl.

	Abstract

To compare in patients with CF who are on maintenance therapy with rhDNase the efficacy and possible side effects of nebulisation of rhDNase before bedtime or after waking up.

Design: randomized, double blind, double dummy, cross over study. Inclusion criteria: CF, stable clinical condition, rhDNase maintenance therapy. Children in Group I inhaled rhDNase before bedtime, and a placebo after waking up in week 1-2. The protocol was reversed during week 3-4. Group II performed the reversed sequence. Patients continued their daily routine sputum expectoration. Primary endpoint: MEF₂₅. Pulmonary functions tests were performed on day 0, 7, 14, 21 and 28. At 1, 2, 3 and 4 weeks oxygen saturation and cough frequency were measured during the night.

24 patients completed the study. Mean age: 13 years (range 6-19). MEF₂₅ (%pred) as primary endpoint did not show a significant difference between nebulisation of rhDNase before bedtime or after waking up. Nocturnal cough, oxygen saturation, or the other secondary end points were not significantly different between the two study periods.

In children with CF who are on maintenance treatment with rhDNase it is equally effective and safe to nebulise rhDNase before bedtime compared to after waking up.