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
| ISRCTN | ISRCTN74815264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74815264 |
| Secondary identifying numbers | NTR282 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 13/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lianne van der Giessen
Scientific
Scientific
Erasmus Medical Center
Sophia Children's Hospital
Department Paediatric Physiotherapy
SK 0327, Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 463 6764 |
|---|---|
| L.vandergiessen@erasmusmc.nl |
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2004 |
| Completion date | 01/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 25 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Roche Nederland BV (Netherlands)
Industry
Industry
Postbus 44
Woerden
3440 AA
Netherlands
| Website | http://www.roche.nl |
|---|---|
"ROR" |
https://ror.org/01gcg9888 |
Funders
Funder type
Industry
Roche Nederland BV (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2007 | Yes | No |
Editorial Notes
13/09/2017: internal review
