Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

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

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. 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

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

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

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

Publication citations

Additional files

Editorial Notes