Efficacy of inhaled DNase in children with an airway malacia and a lower respiratory tract infection
ISRCTN | ISRCTN85366144 |
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DOI | https://doi.org/10.1186/ISRCTN85366144 |
Secondary identifying numbers | NTR241 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
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 |
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r.boogaard@erasmusmc.nl |
Study information
Study design | Randomised double blind placebo controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Efficacy of inhaled DNase in children with an airway malacia and a lower respiratory tract infection |
Study objectives | We hypothesise that DNase improves mucociliary clearance and mucus retention in patients with (trachea) bronchomalacia during a lower respiratory tract infection, resulting in a faster resolution of symptoms and shorter duration of a lower respiratory tract infection. |
Ethics approval(s) | Received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Tracheobronchomalacia, lower respiratory tract disease (LRTD) |
Intervention | Inhaled 2.5 mg DNase or placebo, twice daily for two weeks. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | DNase |
Primary outcome measure | Decrease in mean daily Cough Symptom Score (CSS) |
Secondary outcome measures | 1. Need for additional antibiotics 2. Mean daily cough severity and coughability of sputum (VAS-score) 3. CSS and VAS on each treatment day 4. Lung function (FEV1, FVC, PEF, MEF25, RINT) 5. Parents' perception about treatment efficacy 6. Doctors diagnosed end of infection after 1 and 2 weeks treatment |
Overall study start date | 01/09/2005 |
Completion date | 01/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 2 Years |
Upper age limit | 18 Years |
Sex | Both |
Target number of participants | 40 |
Total final enrolment | 40 |
Key inclusion criteria | 1. Children aged 2 - 18 years with tracheobronchomalacia (diagnosed bronchoscopically) 2. Symptoms of a lower respiratory tract infection |
Key exclusion criteria | 1. Indication for a course of antibiotics at presentation (assessed by paediatric pulmonologist) 2. Co-existing chronic pulmonary disease (eg cystic fibrosis, broncho pulmonary dysplasia or primary ciliary dyskinesia) 3. History of oesophageal atresia 4. Neuromuscular disease or psychomotor retardation |
Date of first enrolment | 01/09/2005 |
Date of final enrolment | 01/09/2007 |
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 |
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https://ror.org/018906e22 |
Funders
Funder type
Industry
Roche Nederland BV (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/10/2009 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference and total final enrolment added.