Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Other: Drug-like Medical Device: Ectoin Inhalation Solution |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Dose of Metacholine needed to produce a 20% drop in FEV1 as reflection of airway hyperreagibility [ Designated as safety issue: Yes ]Methacholine cumulative dose producing a 20% decrease in Forced Expiratory Volume in 1 second (FEV1) (defined as PD20)
| Enrollment: | 18 |
| Study Start Date: | September 2009 |
| Study Completion Date: | February 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. 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. |
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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Bitop AG |
| ClinicalTrials.gov Identifier: | NCT01478152 History of Changes |
| Other Study ID Numbers: | K-AN |
| Study First Received: | November 17, 2011 |
| Last Updated: | November 21, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bitop AG:
|
Asthma Ectoin Ectoine |
FeNO Metacholin sRaw |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013