COPDEFECTNCT01225965
Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung
A study testing Ectoin Inhalation Solution in people with COPD and Particulate Matter Induced Inflammation of the Lung, run by Bitop AG at 1 site in Germany.
Trial summary
To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in subjects of the established SALIA-cohort and the preventive effects on lung function decline. Read more about this study
- Who is it for?
- Ages 75 to 80 years, women only
- Conditions the study is for
- COPD, Particulate Matter Induced Inflammation of the Lung
- What is being tested?
- Ectoin Inhalation Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Sep 2011
- 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 75 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Postmenopausal females (75 - 80 years)
- FEV1/FVC < 0,77 (in the investigation 2007/2008)
- Inflammatory markers TFN-alpha > median or neutrophilic granulocytes > median (investigation 2007/2008)
- Non smokers or ex smokers who have stopped smoking for longer than 6 months
Who cannot join
- Participation in another clinical study in the previous month
- Severe concomitant disease which may have an impact on the study participation
- Hypersensitivity against Ectoin
- Myocardial infarction or apoplexy within the last year
- Uncontrolled hypertension: systolic blood pressure >200 mmHg or diastolic pressure >120 mmHg
- Known aortic aneurysm
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- Other respiratory diseases (e.g. cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, allergic alveolitis, tuberculosis, etc.)
- 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)
- on investigators decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Efficacy and Feasibility Study to Investigate the Effect of Ectoin® Inhalation Solution (EIL) in Subjects With Inflammation and Airway Obstruction Followed by a Long Term Study Extension on the Prevention of Lung Function Decline
To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in subjects of the established SALIA-cohort and the preventive effects on lung function decline.
- Being tested
- Ectoin Inhalation Solution, Placebo
- Keywords
- Particulate Matter induced inflammation of the lung
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin Inhalation SolutionDevice
Once daily inhalation of Ectoin Inhalation Solution
PlaceboDevice
Once daily inhalation of Placebo Inhalation Solution
| Study group | Role | What they receive |
|---|---|---|
| EIL05, Inhalation | Experimental | Not described Receives: Device: Ectoin Inhalation Solution |
| Placebo, 0,9% NaCl | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD
Change of biomarkers in spautum, exhaled breath condensate and serum after treatment compared to baseline.
Measured: Baseline and 28 days after treatment start
Secondary outcomes (6)
Vital signs
Measured: Baseline and 28 days after treatment start
Reduction of lung function decline
Measured: Baseline and 28 days after treatment start
Change in Quality of life
Measured: Baseline and 28 days after treatment start
Need for rescue medication
Measured: 28 days (during treatment phase)
Occurence of adverse events
Measured: 28 days (during treatment phase)
Lung function parameters
Measured: 28 days (during treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225965
- Sponsor's protocol ID
- PPL-015
- Acronym
- EFECT
- Status last verified
- Jan 2026
- First submitted
- 20 Oct 2010
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
- An Efficacy and Feasibility Study to Investigate the Effect of Ectoin® Inhalation Solution (EIL) in Subjects With Inflammation and Airway Obstruction Followed by a Long Term Study Extension on the Prevention of Lung Function Decline
- ClinicalTrials.gov ID
- NCT01225965
- Acronym / sponsor ID
- EFECT / PPL-015
- Keywords
- Particulate Matter induced inflammation of the lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Oct 2010 (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.
To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in subjects of the established SALIA-cohort and the preventive effects on lung function decline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIL05, Inhalation | Experimental | Device: Ectoin Inhalation Solution |
| Placebo, 0,9% NaCl | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 75 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Postmenopausal females (75 - 80 years)
- FEV1/FVC < 0,77 (in the investigation 2007/2008)
- Inflammatory markers TFN-alpha > median or neutrophilic granulocytes > median (investigation 2007/2008)
- Non smokers or ex smokers who have stopped smoking for longer than 6 months
Key exclusion criteria (9 listed)
- Participation in another clinical study in the previous month
- Severe concomitant disease which may have an impact on the study participation
- Hypersensitivity against Ectoin
- Myocardial infarction or apoplexy within the last year
- Uncontrolled hypertension: systolic blood pressure >200 mmHg or diastolic pressure >120 mmHg
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 |
|---|---|---|
| Ectoin Inhalation SolutionOnce daily inhalation of Ectoin Inhalation Solution | Device | EIL05, Inhalation |
| PlaceboOnce daily inhalation of Placebo Inhalation Solution | Device | Placebo, 0,9% NaCl |
Primary outcome
Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD
Time frame: Baseline and 28 days after treatment start
Change of biomarkers in spautum, exhaled breath condensate and serum after treatment compared to baseline.
6 secondary outcomes
Vital signs
Time frame: Baseline and 28 days after treatment start
Reduction of lung function decline
Time frame: Baseline and 28 days after treatment start
Change in Quality of life
Time frame: Baseline and 28 days after treatment start
Need for rescue medication
Time frame: 28 days (during treatment phase)
Occurence of adverse events
Time frame: 28 days (during treatment phase)
Lung function parameters
Time frame: 28 days (during treatment phase)
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.
- Website of the Institut für umweltmedizinische ForschungLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ectoin Inhalation Solution in people with COPD and Particulate Matter Induced Inflammation of the Lung, 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 4 inclusion and 9 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. Some participants in this study may receive a placebo. 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?
Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD (time frame: Baseline and 28 days after treatment start). 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.