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

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ClinicalTrials.gov Identifier: NCT01478152
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : November 23, 2011
Sponsor:
Information provided by (Responsible Party):
Bitop AG

Tracking Information
First Submitted Date  ICMJE November 17, 2011
First Posted Date  ICMJE November 23, 2011
Last Update Posted Date November 23, 2011
Study Start Date  ICMJE September 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2011)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
Official Title  ICMJE A Single Center, Dose Finding, Safety, and Feasibility Study to Investigate the Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE 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.

Study Arms  ICMJE 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.

Intervention: Other: Drug-like Medical Device: Ectoin Inhalation Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2011)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01478152
Other Study ID Numbers  ICMJE K-AN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bitop AG
Study Sponsor  ICMJE Bitop AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Meyer, MD Inamed Research GmbH
PRS Account Bitop AG
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP