Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01225965

Acronym

EFECT

Enrollment

Registered

2010-10-21

Start date

2010-10-01

Completion date

2011-09-01

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Particulate Matter Induced Inflammation of the Lung

Keywords

Particulate Matter induced inflammation of the lung

Brief 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.

Interventions

DEVICEEctoin Inhalation Solution

Once daily inhalation of Ectoin Inhalation Solution

DEVICEPlacebo

Once daily inhalation of Placebo Inhalation Solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

75 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD	Baseline and 28 days after treatment start	Change of biomarkers in spautum, exhaled breath condensate and serum after treatment compared to baseline.

Secondary

Measure	Time frame
Vital signs	Baseline and 28 days after treatment start
Reduction of lung function decline	Baseline and 28 days after treatment start
Change in Quality of life	Baseline and 28 days after treatment start
Need for rescue medication	28 days (during treatment phase)
Occurence of adverse events	28 days (during treatment phase)
Lung function parameters	28 days (during treatment phase)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026