Contact information
Type
Scientific
Primary contact
Dr R Boogaard
ORCID ID
Contact details
Erasmus Medical Centre
Sophia Childrens Hospital
Department of Pediatric Pulmonology
SB-2666
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 463 6683
r.boogaard@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR241
Study information
Scientific title
Acronym
Study hypothesis
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
Received from the local medical ethics committee
Study design
Randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Tracheobronchomalacia, lower respiratory tract disease (LRTD)
Intervention
Inhaled 2.5 mg DNase or placebo, twice daily for two weeks.
Intervention type
Drug
Phase
Not Applicable
Drug names
DNase
Primary outcome measures
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 trial start date
01/09/2005
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged 2 - 18 years with tracheobronchomalacia (diagnosed bronchoscopically)
2. Symptoms of a lower respiratory tract infection
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/09/2005
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Sponsor type
Hospital/treatment centre
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
Results - basic reporting
Publication summary