ISRCTN71537084
Completed
Not Applicable
Efficacy of peripherally targeted inhaled rhDNase for persistent obstructive asthma in childhood
Erasmus Medical Center (The Netherlands)0 sites60 target enrollmentJune 9, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive pulmonary function, asthma
- Sponsor
- Erasmus Medical Center (The Netherlands)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 6 \- 18 years
- •2\. Asthma diagnosed according to Global Initiative For Asthma (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 Inhaled Corticosteroid (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 forced vital capacity (FVC) and FEF75 values: FEF75 at least 20% (absolute % predicted) lower than FVC (FEF \= Forced Expiratory Flow rate)
- •8\. FVC within normal limits (for this study defined as FVC \>80% predicted)
Exclusion Criteria
- •1\. Asthma exacerbation with hospital admission in last three 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 can affect inhaled treatment (e.g. cleft palate, severe malacia)
- •7\. Neuromuscular disease
- •8\. Smoking
Outcomes
Primary Outcomes
Not specified
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