Peripheral targeting of inhaled rhDNase for chronic obstructive asthma in childhood.
- Conditions
- asthma10038716
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Age 6 - 18 years;
Asthma diagnosed according to GINA guidelines;
Treatment with at least 400 microg/day inhaled Budesonide or equivalent (dose constant for at least 6 months) and bronchodilators as needed or daily;
Clinically stable asthma while using a constant dose of inhaled corticosteroids (ICS);
Persistent peripheral airways obstruction as assessed by pulmonary function testing, defined as:
o Dissociation between FVC and FEF75 values: FEF75 at least 20% (absolute % predicted) lower than FVC. ;FVC within normal limits (for this study defined as FVC > 80% pred).
Asthma exacerbation with hospital admission in last 3 months;
Intensive Care Unit (ICU) admission for asthma in last year;
Current respiratory tract infection;
Inability to follow instructions of the investigator;
Inability to inhale rhDNase;
Concomitant medical conditions that effect inhaled treatment (e.g. cleft palate, severe airway malacia);
Neuromuscular disease;
Smoking.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the percent change in FEF75. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will include:<br /><br>§ Lung clearance index (LCI) measurements as assessed by multiple breath<br /><br>washout;<br /><br>§ Cumulative symptom diary scores evaluating asthma symptoms in the 2nd week of<br /><br>intervention (e.g. shortness of breath, cough, exercise intolerance,<br /><br>bronchodilator use etc.);<br /><br>§ FENO;<br /><br>§ Other values obtained in the flow volume curve: FEV1, FVC, PEF.</p><br>