Efficacy of inhaled rhDNase for acute asthma in childhood
| ISRCTN | ISRCTN81874766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81874766 |
| Secondary identifying numbers | NTR240 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 13/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr R Boogaard
Scientific
Scientific
Erasmus Medical Centre
Sophia Childrens Hospital
Department of Pediatric Pulmonology, SB-2666
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
| Phone | +31 (0)10 463 6683 |
|---|---|
| r.boogaard@erasmusmc.nl |
Study information
| Study design | Multicentre randomised double-blind placebo-controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | We hypothesise that rhDNase can liquefy sputum in acute asthma resulting in less airways obstruction, reduced work of breathing, and diminished ventilation-perfusion mismatch, thereby improving symptoms, reducing the number of patients who need to be admitted, and shorten the duration of admission. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Condition | Acute Asthma |
| Intervention | One dose of 5 mg rhDNase or one dose of 5 mg placebo in addition to standard care. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | rhDNase |
| Primary outcome measure | Improvement in asthma score 1 hour after intervention. |
| Secondary outcome measures | 1. Need for hospital admission 2. Duration of hospital admission 3. Asthma score at 2, 6, 12 and 24 hours after intervention 4. Heart rate, respiratory rate and oxygen saturation 5. Need for additional oxygen 6. Number of bronchodilators 7. Doctors visit or readmission and use of rescue bronchodilator aerosol therapy following 72 hours after discharge from EMD 8. Cost-consequence analysis |
| Overall study start date | 15/09/2005 |
| Overall study end date | 15/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | Children, aged 2 - 18 years, with acute asthma who require at least two doses of bronchodilators at the Emergency Department. |
| Participant exclusion criteria | 1. Dyspnoea due to other causes than asthma 2. Patients with a concurrent chronic pulmonary disease, such as cystic fibrosis (CF), bronchopulmonary dysplasia (BPD) 3. Patients with a symptomatic cardial or neuromuscular disease |
| Recruitment start date | 15/09/2005 |
| Recruitment end date | 15/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands
3000 CB
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Website | http://www.erasmusmc.nl/content/englishindex.htm |
|---|---|
"ROR" |
https://ror.org/018906e22 |
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 |
