Status:
COMPLETED
Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
Lead Sponsor:
Bitop AG
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 t...
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 hyperresponsi...
Eligibility Criteria
Inclusion
- Adults (18 - 65 years)
- FEV1 ≥ 80% of predicted for patient's normal value pre bronchodilator (according to European Coal and Steel Community reference values)
- Positive Methacholine challenge test (PD20 ≤ 0.5 mg)
- A general practitioner or consultant diagnosed mild bronchial asthma
- Non or ex smoker (for more than 6 months, pack years (PY) ≤ 5)
Exclusion
- Pregnant or lactating females
- Participation in another clinical study in the previous month
- Severe concomitant disease which may have an impact on the study participation
- Hypersensibility against Ectoin®
- Patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (Inactivated influenza vaccination is acceptable, provided it is not administered within 7 days prior to screening visit).
- Other respiratory diseases (e.g. Chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, etc.)
- Upper and lower airway respiratory infection within 4 weeks prior to study start
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01478152
Start Date
September 1 2009
End Date
February 1 2010
Last Update
November 23 2011
Active Locations (1)
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1
Inamed Research GmbH & Co KG
Gauting, Bavaria, Germany, 82131