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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20292
Enrollment
40
Registered
2005-09-06
Start date
2005-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheobronchomalacia and a lower respiratory tract infection

Interventions

Inhaled 2,5 mg DNase or placebo, twice daily for two weeks.

Sponsors

Erasmus MC-Sophia Children's Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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); 3. History of oesophageal atresia; 4. Neuromuscular disease or psychomotor retardation.

Design outcomes

Primary

MeasureTime frame
Decrease in mean daily Cough Symptom Score (CSS).

Secondary

MeasureTime frame
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. Parent’s perception about treatment efficacy; 6. Doctor’s diagnosed end of infection after 1 and 2 weeks treatment.

Contacts

Public ContactR. Boogaard

Erasmus Medical Center, Sophia Children’s Hospital, Department of Pediatric Pulmonology, SB-2666, P.O. Box 2060

r.boogaard@erasmusmc.nl+31 (0)10 4636683

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)