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
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

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

Study information

Study designRandomised double blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEfficacy of inhaled DNase in children with an airway malacia and a lower respiratory tract infection
Study objectivesWe 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) studiedTracheobronchomalacia, lower respiratory tract disease (LRTD)
InterventionInhaled 2.5 mg DNase or placebo, twice daily for two weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)DNase
Primary outcome measureDecrease in mean daily Cough Symptom Score (CSS)
Secondary outcome measures1. 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 study start date01/09/2005
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit18 Years
SexAll
Target number of participants40
Total final enrolment40
Key inclusion criteria1. Children aged 2 - 18 years with tracheobronchomalacia (diagnosed bronchoscopically)
2. Symptoms of a lower respiratory tract infection
Key exclusion criteria1. 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 enrolment01/09/2005
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands

Sponsor information

Funders

Funder type

Industry

Roche Nederland BV (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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

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