Contact information
Type
Scientific
Primary contact
Dr Lianne van der Giessen
ORCID ID
Contact details
Erasmus Medical Center
Sophia Children's Hospital
Department Paediatric Physiotherapy
SK 0327
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 463 6764
L.vandergiessen@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR282
Study information
Scientific title
A double-blind, randomised, double dummy, cross-over, study to assess the difference in efficacy between nebulisation of rhDNase in the morning versus nebulisation before going to sleep
Acronym
Study hypothesis
Inhalation of rhDNase before sleep increases the expiratory flow at 25% of the actual forced vital capacity (MEF25) compared to inhalation of rhDNase in the morning.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cystic fibrosis
Intervention
All subjects nebulised daily both rhDNase (2.5 mg of rhDNase in 2.5 ml buffered solution: 8.77 mg/ml sodium chloride and 0.15 mg/ml calcium chloride) and a placebo (2.5 ml of a buffered solution: 8.77 mg/ml sodium chloride and 0.15 mg/ml calcium chloride) once daily for a period of four weeks.
Placebo was similar to rhDNase in both colour and taste. Subjects were randomised to two groups:
1. Group I used rhDNase before going to sleep and the placebo in the morning. Airway clearance techniques are performed 30 minutes after the nebulisation. In the following two rhDNase and placebo were taken in reversed order.
2. Group II used placebo before going to sleep and rhDNase in the morning. Airway clearance techniques are performed 30 minutes after the nebulisation.
In the following two weeks placebo and rhDNase were taken in reversed order. Patients were asked to carry out their daily routine ACT and not to change their routine technique.
Intervention type
Drug
Phase
Not Applicable
Drug names
rhDNase
Primary outcome measure
Pulmonary function test: MEF25
Secondary outcome measures
1. Pulmonary function tests: FVC, forced expiratory volume in one second (FEV1), Rint
2. Frequency and duration of coughing measured with audio recording
3. Oxygenation at night recording transcutaneous oxygen saturation; percentage with saturation below 95%
4. Severity of cough with a verbal category descriptive (VCD) score
5. Sputum characteristics: amount, viscosity with a visual analogue scale (VAS) score
6. Quality of sleep and appetite with a VAS score
7. Presence of morning sickness
Overall trial start date
01/09/2004
Overall trial end date
01/02/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Proven cystic fibrosis (CF), as evidenced by an abnormal sweat test or an abnormal rectum potential difference measurement or by the presence of two CF mutations and at least one clinical feature of CF
2. Treated at the Erasmus Medical Centre - Sophia
3. Five years and older
4. Able to perform reproducible manoeuvres for spirometry
5. Maintenance treatment with rhDNase for at least one month
6. Clinically stable for at least one month (no intravenous antibiotics and/or hospitalisations within one month before enrolment)
7. Willing to participate in and comply with study procedures, and willingness of the parent or guardian and subjects greater than 12 years to provide written informed consent
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
25
Participant exclusion criteria
1. Forced vital capacity (FVC) less than 40%
2. Using rhDNase more than once daily
3. Mentally retarded
4. History of non-adherence to treatment advice known to the physician
Recruitment start date
01/09/2004
Recruitment end date
01/02/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Sponsor information
Organisation
Roche Nederland BV (Netherlands)
Sponsor details
Postbus 44
Woerden
3440 AA
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Roche Nederland BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17596273
Publication citations
-
Results
van der Giessen LJ, Gosselink R, Hop WC, Tiddens HA, Recombinant human DNase nebulisation in children with cystic fibrosis: before bedtime or after waking up?, Eur. Respir. J., 2007, 30, 4, 763-768, doi: 10.1183/09031936.00031107.