Efficacy of inhaled DNase in children with an airway malacia and a lower respiratory tract infection

ISRCTN	ISRCTN85366144
DOI	https://doi.org/10.1186/ISRCTN85366144
Protocol serial number	NTR241
Sponsor	Erasmus Medical Centre (Netherlands)
Funder	Roche Nederland BV (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr R Boogaard
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
Email	r.boogaard@erasmusmc.nl

Primary study design	Interventional
Study design	Randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	DNase
Primary outcome measure(s)	Decrease in mean daily Cough Symptom Score (CSS)
Key secondary outcome measure(s)	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
Completion date	01/09/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	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

Erasmus Medical Centre

Rotterdam
3000 CB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009	07/01/2021	Yes	No

07/01/2021: Publication reference and total final enrolment added.