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

Completed
Conditions
Tracheobronchomalacia, lower respiratory tract disease (LRTD)
Respiratory
Unspecified acute lower respiratory infection
Registration Number
ISRCTN85366144
Lead Sponsor
Erasmus Medical Centre (Netherlands)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
40
Inclusion Criteria

1. Children aged 2 - 18 years with tracheobronchomalacia (diagnosed bronchoscopically)
2. Symptoms of a lower respiratory tract infection

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Decrease in mean daily Cough Symptom Score (CSS)
Secondary Outcome Measures
NameTimeMethod
1. Need for additional antibiotics<br>2. Mean daily cough severity and coughability of sputum (VAS-score)<br>3. CSS and VAS on each treatment day<br>4. Lung function (FEV1, FVC, PEF, MEF25, RINT)<br>5. Parents' perception about treatment efficacy<br>6. Doctor?s diagnosed end of infection after 1 and 2 weeks treatment
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