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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bitop AG
ClinicalTrials.gov Identifier:
NCT01478152
First received: November 17, 2011
Last updated: November 21, 2011
Last verified: November 2011
  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

Resource links provided by NLM:


Further study details as provided by Bitop AG:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478152

Locations
Germany
Inamed Research GmbH & Co KG
Gauting, Bavaria, Germany, 82131
Sponsors and Collaborators
Bitop AG
Investigators
Principal Investigator: Thomas Meyer, MD Inamed Research GmbH
  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
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014