CompletedPhase 4ACTRN12607000155493

Is Dornase alfa (Pulmozyme ) effective if administered at night, in relation to airways clearance techniques? A multi centre, crossover, randomised controlled trial for people with cystic fibrosis.

Sponsor

Royal Children's Hospital

Enrollment

46 participants

Start Date

May 19, 2003

Study Type

Interventional

Conditions

Cystic Fibrosis (CF)

Summary

The aim of this study was to investigate if a longer time interval between rhDNase nebulisation and chest physiotherapy improves clinical outcomes of subjects with CF. METHODS: A single-blind randomised cross-over trial was conducted on subjects with CF from outpatients of 4 hospitals. Subjects were in stable health and studied over 6-weeks (utilising 14-day blocks of morning or evening rhDNase administration with 14-days washout). Usual regimes for physiotherapy and exercise were unaltered. Thus changing the times altered the dwell time of rhDNase prior to physiotherapy. Long interval was defined as dwell time of >6-hours and short as <6-hours. Outcomes were measured at pre and post each regime.

Eligibility

Sex: Both males and femalesMin Age: 5 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether taking Pulmozyme (dornase alfa, a mucus-thinning medication) at night rather than before airway clearance therapy works just as well for people with cystic fibrosis. It is for patients aged 5 and older who are already using Pulmozyme, can perform breathing tests, and have stable lung disease. The study uses a crossover design so each participant tries both timing approaches.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Following randomisation to determine morning or evening Dornase alfa (rhDNase, [Pulmozyme]) administration as commencement intervention, paediatric and adult CF outpatients were studied over a six week period: 14 day regimes of morning or evening rhDNase administration, with 14 days washout between the two regimes. These regimes resulted in alteration of the interval time between rhDNase nebulisation and chest physiotherapy. The subject’s usual routine for chest physiotherapy and exercise were unaltered. Outcomes were measured at start and end of each regime when participants attended four study visits (each approximately 30-60 minutes’ duration). The subjects were all current users of nebulised rhDNase (2.5mg unit dose ampoule nebulised once daily via Pari LC+ nebuliser; duration approximately 10 minutes); the study protocol required alteration of the time of day or night at which rhDNase was administered to alter the in-situ dwell time of rhDNase in relation to chest physiotherapy. Usual timing of rhDNase administration in relation to chest physiotherapy is highly variable, with "short" intervals in some users (eg 15 minutes prior to physiotherapy) and others having a "long" interval (eg 8-10 hours if rhDNase is taken at night). Patients acted as their own control, using their "usual" timing during the washout period of 14 days, and data was analysed with consideration of "usual" in-situ dwell time of rhDNase compared to longer or shorter intervals caused by the study protocol.