Efficacy of peripherally targeted inhaled rhDNase for persistent obstructive asthma in childhood

Erasmus Medical Centre Rotterdam0 个研究点目标入组 60 人开始时间: 2006年7月5日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

Erasmus Medical Centre Rotterdam