Efficacy of inhaled DNase in children with an airway malacia and a lowerrespiratory tract infection.
Completed
- Conditions
- Tracheobronchomalacia and a lower respiratory tract infection
- Registration Number
- NL-OMON20292
- Lead Sponsor
- Erasmus MC-Sophia Children's Hospital
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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 pediatric pulmonologist);
2. Co-existing chronic pulmonary disease (e.g. cystic fibrosis, broncho pulmonary dysplasia or primary ciliary dyskinesia);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in mean daily Cough Symptom Score (CSS).
- Secondary Outcome Measures
Name Time Method 1. Need for additional antibiotics;<br /><br>2. Mean daily cough severity” and coughability of sputum” (VAS-score);<br /><br>3. CSS and VAS on each treatment day;<br /><br>4. Lung function (FEV1, FVC, PEF, MEF25, RINT);<br /> <br>5. Parent’s perception about treatment efficacy;<br /> <br>6. Doctor’s diagnosed end of infection after 1 and 2 weeks treatment.