Efficacy of peripherally targeted inhaled rhDNase for persistent obstructive asthma in childhood.
- Conditions
- asthma with persistent obstructive pulmonary function.
- Registration Number
- NL-OMON21320
- Lead Sponsor
- ErasmusMC Rotterdam
- Brief Summary
1. Fuchs, H.J., et al., Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. The Pulmozyme Study Group. N Engl J Med, 1994. 331(10): p. 637-42. 2. King, M., et al., Rheology of cystic fibrosis sputum after in vitro treatment with hypertonic saline alone and in combination with recombinant human deoxyribonuclease I. Am J Respir Crit Care Med, 1997. 156(1): p. 173-7. 3. Hodson, M.E. and P.L. Shah, DNase trials in cystic fibrosis. Eur Respir J, 1995. 8(10): p. 1786-91. 4. Greally, P., Human recombinant DNase for mucus plugging in status asthmaticus. Lancet, 1995. 346(8987): p. 1423-4 5. Durward, A., V. Forte, and S.D. Shemie, Resolution of mucus plugging and atelectasis after intratracheal rhDNase therapy in a mechanically ventilated child with refractory status asthmaticus. Crit Care Med, 2000. 28(2): p. 560-2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Age 6 – 18 years;
2. Asthma diagnosed according to GINA guidelines;
1. Asthma exacerbation with hospital admission in last 3 months;
2. Intensive Care Unit (ICU) admission for asthma within the last year;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary endpoints will include: <br /><br>1. Lung clearance index (LCI) measurements as assessed by multiple breath washout; <br /><br>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.);<br /><br>3. FENO;<br /><br>4. Other values obtained in the flow volume curve: FEV1, FVC, PEF.