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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478152
• Other study ID #: K-AN
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2011
• Last updated: November 21, 2011
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2011
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Germany	Inamed Research GmbH & Co KG	Gauting	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Yes