ISRCTN71537084CompletedNot Applicable
Efficacy of peripherally targeted inhaled rhDNase for persistent obstructive asthma in childhood
Erasmus Medical Center (The Netherlands)0 sites60 target enrollmentStarted: June 9, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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