A double-blind, randomised, double dummy, cross over, study to assess the difference in efficacy between nebulisation of rhDNase before airway clearance therapy (ACT) versus nebulisation after ACT
| ISRCTN | ISRCTN87248226 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87248226 |
| Secondary identifying numbers | NTR352 |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 24/08/2009
- 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 Giessen, van der
Scientific
Scientific
Erasmus Medical Center
Sophia Children's Hospital
Department Pediatric Physiotherapy
SK 0327
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636764 |
|---|---|
| L.vandergiessen@erasmusmc.nl |
Study information
| Study design | Randomised double blind double dummy placebo controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Inhalation of rhDNase after airway clearance therapy (ACT) increases the expiratory flow at 25% of the actual forced vital capacity (MEF25) compared to inhalation of rhDNase before ACT. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Cystic Fibrosis (CF) |
| Intervention | The study was a randomised, double blind, double dummy, cross over design. All subjects nebulized 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 six weeks. Placebo was similar to rhDNase in both color and taste. Subjects were randomised to two groups: Group I used rhDNase 30 minutes before ACT and placebo directly after ACT in the first three weeks. In the following three weeks rhDNase and placebo were taken in reversed order. Group II used placebo 30 minutes before ACT and rhDNase after ACT in the first three weeks. In the following three 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. The timing during the day of nebulisation and ACT were kept constant throughout the study. |
| Intervention type | Other |
| Primary outcome measure | Pulmonary function tests: MEF25 |
| Secondary outcome measures | 1. Pulmonary function tests: 1.1. Forced vital capacity (FVC) 1.2. Forced expiratory volume in one second (FEV1) 1.3. Rint 2. Severity of cough with a VCD score 3. Sputum characteristics: amount, viscosity with a visual analogue scale (VAS) |
| Overall study start date | 01/08/2003 |
| Completion date | 01/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | 1. Proven 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 MC - Sophia, and: 2.1. Five years or older 2.2. Able to perform reproducible manoeuvres for spirometry 2.3. Carrying out daily CPT 2.4. Maintenance treatment with rhDNase for at least one month 2.5. Clinically stable for at least one month (no intravenous antibiotics and/or hospitalisations within one month before enrolment) 3. Willing to participate in and comply with study procedures, and willingness of the parent or guardian and of the subjects >12 years to provide written informed consent |
| Key exclusion criteria | 1. Using rhDNase more than once daily 2. Mental retardation 3. Having a history of non-adherence to treatment advice known to the physician |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/07/2004 |
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
P.O. Box 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 | 01/07/2007 | Yes | No |
