AsthmaNCT01478152
Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
A study testing Drug-like Medical Device: Ectoin Inhalation Solution in people with Asthma, run by Bitop AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Drug-like Medical Device: Ectoin Inhalation Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Drug-like Medical Device: Ectoin Inhalation Solution
- Keywords
- Asthma, Ectoin, Ectoine, FeNO, Metacholin, sRaw
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-like Medical Device: Ectoin Inhalation SolutionOther
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 group | Role | What they receive |
|---|---|---|
| Ectoin Inhalation Solution | Experimental | 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. Receives: Other: Drug-like Medical Device: Ectoin Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Meyer, MD, Principal investigator, Inamed Research GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478152
- Sponsor's protocol ID
- K-AN
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2011
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01478152
- Acronym / sponsor ID
- K-AN
- Conditions
- Asthma
- Keywords
- Asthma, Ectoin, Ectoine, FeNO, Metacholin, sRaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2009 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ectoin Inhalation Solution | Experimental | Other: Drug-like Medical Device: Ectoin Inhalation SolutionAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-like Medical Device: Ectoin Inhalation SolutionAfter 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. | Other | Ectoin Inhalation Solution |
Primary outcome
Dose of Metacholine needed to produce a 20% drop in FEV1 as reflection of airway hyperreagibility
Time frame: 5 to 7 days
Methacholine cumulative dose producing a 20% decrease in Forced Expiratory Volume in 1 second (FEV1) (defined as PD20)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Meyer, MD principal investigator
Inamed Research GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-like Medical Device: Ectoin Inhalation Solution in people with Asthma, run by Bitop AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Metacholine needed to produce a 20% drop in FEV1 as reflection of airway hyperreagibility (time frame: 5 to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.