NCT01478152

Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma

A Single Center, Dose Finding, Safety, and Feasibility Study to Investigate the Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Bitop AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Drug-like Medical Device: Ectoin Inhalation Solution	After baseline visit subjects will receive 0.9% saline inhalation solution for placebo. Patients will be instructed to inhale once daily with the AKITA2® APIXNEB® inhalation system for 5 - 7 days. The treatment phase with low dose of Ectoin® will follow subsequently without any washout phase. This treatment phase will be repeated for medium and a high Ectoin® dose. All doses of Ectoin® inhalation solution will be administered for 5 - 7 days without any washout phase. To minimize circadian variations Methacholine challenge tests will be performed always at the approximately same time. Sputum inductions will be conducted on the last but one day of placebo treatment phase and on the last but one day of treatment phase with the highest Ectoin® dose.

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2011-11-23
• Last updated: 2026-01-29

Locations

1 site across 1 country: Germany