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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Drug-like Medical Device: Ectoin Inhalation Solution

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Ectoin, Ectoine, FeNO, Metacholin, sRaw

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Inamed Research GmbH & Co KG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ectoin Inhalation Solution

Arm Description

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.

Outcomes

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT01478152

First Posted

November 17, 2011

Last Updated

November 21, 2011

Sponsor

Bitop AG

1. Study Identification

Unique Protocol Identification Number

NCT01478152

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bitop AG

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Ectoin, Ectoine, FeNO, Metacholin, sRaw

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ectoin Inhalation Solution

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Drug-like Medical Device: Ectoin Inhalation Solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dose of Metacholine needed to produce a 20% drop in FEV1 as reflection of airway hyperreagibility

Description

Methacholine cumulative dose producing a 20% decrease in Forced Expiratory Volume in 1 second (FEV1) (defined as PD20)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Meyer, MD

Organizational Affiliation

Inamed Research GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inamed Research GmbH & Co KG

City

Gauting

State/Province

Bavaria

ZIP/Postal Code

82131

Country

Germany

12. IPD Sharing Statement

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

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