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

Sponsor

Bitop AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01478152

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Asthma	Other: Drug-like Medical Device: Ectoin Inhalation Solution	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2009

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Dose of Metacholine needed to produce a 20% drop in FEV1 as reflection of airway hyperreagibility []
Methacholine cumulative dose producing a 20% decrease in Forced Expiratory Volume in 1 second (FEV1) (defined as PD20)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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