Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
NCT ID: NCT01478152
Last Updated: 2011-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2009-09-30
2010-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Bitop AG
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Meyer, MD
Role: PRINCIPAL_INVESTIGATOR
Inamed Research GmbH
Locations
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Inamed Research GmbH & Co KG
Gauting, Bavaria, Germany
Countries
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Other Identifiers
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K-AN
Identifier Type: -
Identifier Source: org_study_id