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Efficacy of inhaled DNase in children with an airway malacia and a lowerrespiratory tract infection.


- candidate number1420
- NTR NumberNTR241
- ISRCTNISRCTN85366144
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsN/A 
- Public TitleEfficacy of inhaled DNase in children with an airway malacia and a lowerrespiratory tract infection.
- Scientific TitleEfficacy of inhaled DNase in children with an airway malacia and a lowerrespiratory tract infection.
- ACRONYMN/A
- hypothesisWe hypothesize 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.
- Healt Condition(s) or Problem(s) studiedLower Respiratory Tract Disease (LRTD), Tracheobronchomalacia
- Inclusion criteria1. Children aged 2-18 years with tracheobronchomalacia (diagnosed bronchoscopically);
2. Symptoms of a lower respiratory tract infection.
- Exclusion criteria1. Indication for a course of antibiotics at presentation (assessed by pediatric pulmonologist);
2. Co-existing chronic pulmonary disease (e.g. cystic fibrosis, broncho pulmonary dysplasia or primary ciliary dyskinesia);
3. History of oesophageal atresia;
4. Neuromuscular disease or psychomotor retardation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-sep-2007
- Target number of participants40
- InterventionsInhaled 2,5 mg DNase or placebo, twice daily for two weeks.
- Primary outcomeDecrease in mean daily Cough Symptom Score (CSS).
- Secondary outcome1. 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. Parent’s perception about treatment efficacy;
6. Doctor’s diagnosed end of infection after 1 and 2 weeks treatment.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. R. Boogaard
- CONTACT for SCIENTIFIC QUERIESMD. R. Boogaard
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD6-sep-2005 - 5-jan-2010


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