Asthma is a chronic inflammatory disorder in which many cells play a role, in particular mast cells, eosinophils and T lymphocytes. In susceptible individuals this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness and cough. These symptoms are usually associated with widespread but variable airflow limitation that is at least partly reversible either spontaneously or with treatment. MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Pulmozyme
Product Name: rhDNase (tradename: Pulmozyme)
Pharmaceutical Form: Inhalation vapour, solution
Pharmaceutical form of the placebo: Inhalation vapour*
Route of administration of th
Sponsors
Erasmus Medical Centre Rotterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 6 – 18 years; - Asthma diagnosed according to GINA guidelines; - Attending the outpatient clinic for at least one year; - Treatment with at least 400 mg/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 ICS; - Ability to perform lung function tests (assessed by trained lung function technician); - 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. - FVC within normal limits (for this study defined as FVC > 80% pred). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Asthma exacerbation with hospital admission in last 3 months; - Intensive Care Unit (ICU) admission for asthma in the 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 malacia); - Neuromuscular disease; - Smoking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of treatment with nebulized rhDNase on pulmonary function in children with persistent asthma and persistent peripheral airflow limitation.;Secondary Objective: To investigate the effect of treatment with nebulized rhDNase on lung clearance index (LCI), FENO values and symptom scores in children with asthma and persistent peripheral airway obstruction. ;Primary end point(s): 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. | — |
Countries
Netherlands
Outcome results
None listed