EUCTR2006-002337-20-NL
Active, not recruiting
Not Applicable
Efficacy of peripherally targeted inhaled rhDNase for persistent obstructive asthma in childhood
Erasmus Medical Centre Rotterdam0 sites60 target enrollmentJuly 5, 2006
ConditionsAsthma 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: 8.1Level: LLTClassification code 10003553Term: Asthma
DrugsPulmozyme
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 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.
- Sponsor
- Erasmus Medical Centre Rotterdam
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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