Asthma Clinical Trial
Official title:
A Single Center, Dose Finding, Safety, and Feasibility Study to Investigate the Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation solution will be investigated in subjects with mild bronchial asthma. This dose-finding study will estimate the minimum effective dose and will assess the safe dosage, in terms of the quantity given to patients. The results will be compared to baseline measurements. The results regarding Sputum measurements will be compared to measurements after placebo administration.
Based on the anti-inflammatory effects of inhaled Ectoin® shown in previous animal studies,
this trial aims to investigate the effects in terms of a reduction of the unspecific
bronchial hyperresponsiveness (BHR) to Methacholine challenge test on subjects with mild
bronchial asthma. In addition, measurements of exhaled nitric oxide level as an indicator of
bronchial inflammation will be investigated.
This study will focus primarily on safety and dose finding in 12 to 18 subjects with mild
bronchial asthma.
After a screening visit, subjects will be treated with placebo, followed by increasing doses
of Ectoin® (low, medium and high dose). All doses of Ectoin® inhalation solution and placebo
will be administered for 5 - 7 days.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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