No registrations found.
ID
Source
Brief title
Health condition
Tracheobronchomalacia and a lower respiratory tract infection
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decrease in mean daily Cough Symptom Score (CSS).
Secondary outcome
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.
Background summary
N/A
Study objective
We 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.
Study design
N/A
Intervention
Inhaled 2,5 mg DNase or placebo, twice daily for two weeks.
P.O. Box 2060
R. Boogaard
Rotterdam 3000 CB
The Netherlands
+31 (0)10 4636683
r.boogaard@erasmusmc.nl
P.O. Box 2060
R. Boogaard
Rotterdam 3000 CB
The Netherlands
+31 (0)10 4636683
r.boogaard@erasmusmc.nl
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);
3. History of oesophageal atresia;
4. Neuromuscular disease or psychomotor retardation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL204 |
| NTR-old | NTR241 |
| Other | : N/A |
| ISRCTN | ISRCTN85366144 |