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

Plain English Summary

Not provided at time of registration

Trial website

Type

Scientific

Primary contact

Dr R Boogaard

ORCID ID

Contact details

Erasmus Medical Centre
Sophia Children’s Hospital
Department of Pediatric Pulmonology
SB-2666
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 463 6683
r.boogaard@erasmusmc.nl

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR241

Scientific title

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

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 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. Doctor’s 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 (if study stopped)

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

Total final enrolment

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

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funder type

Industry

Funder name

Roche Nederland BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2009 results in https://pubmed.ncbi.nlm.nih.gov/19768804/ (added 07/01/2021)

Publication citations

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