asthma with persistent obstructive pulmonary function.
Conditions
Interventions
Nebulization with rhDNase or placebo once daily (each participant is treated for 2 weeks with rhDNase and for 2 weeks with placebo).
Sponsors
ErasmusMC Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 6 – 18 years; 2. Asthma diagnosed according to GINA guidelines; 3 Attending the outpatient clinic for at least one year; 4.Treatment with at least 400 mg/day inhaled Budesonide or equivalent (dose constant for at least 6 months) and bronchodilators as needed or daily; 5. Clinically stable asthma while using a constant dose of ICS for at least three months; 6. Ability to perform lung function tests (assessed by trained lung function technician); 7. Persistent peripheral airways obstruction as assessed by pulmonary function testing, defined as: dissociation between FVC and FEF75 values: FEF75 at least 20% (absolute % predicted) lower than FVC; 8. FVC within normal limits (for this study defined as FVC > 80% pred).
Exclusion criteria
Exclusion criteria: 1. Asthma exacerbation with hospital admission in last 3 months; 2. Intensive Care Unit (ICU) admission for asthma within the last year; 3. Current respiratory tract infection; 4. Inability to follow instructions of the investigator; 5. Inability to inhale rhDNase; 6. Concomitant medical conditions that effect inhaled treatment (e.g. cleft palate, severe malacia); 7. Neuromuscular disease; 8. Smoking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the change in FEF75 as a result of treatment. FEF75 is the most suitable endpoint since it is sensitive to peripheral airways obstruction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include: 1. Lung clearance index (LCI) measurements as assessed by multiple breath washout; 2. Cumulative symptom diary scores evaluating asthma symptoms in the 2nd week of intervention (e.g. shortness of breath, cough, exercise intolerance, bronchodilator use etc.); 3. FENO; 4. Other values obtained in the flow volume curve: FEV1, FVC, PEF. | — |
Contacts
Public ContactH.A.W.M. Tiddens
Erasmus Medical Center, Sophia Children’s Hospital Rotterdam, Department of Pediatric Pulmonology, Dr. Molewaterplein 60
Outcome results
None listed