Efficacy and Feasibility of Ectoin® Inhalation Solution i... | NCT01225965

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

NCT01225965

Sponsor

Bitop AG

Status

Completed

Last Update Posted

Jan 29, 2026Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

COPD
Particulate Matter Induced Inflammation of the Lung

Interventions

Ectoin Inhalation Solution
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Oct 20, 2010

First Submission Date that Met QC Criteria

Oct 20, 2010

First Posted Date

Oct 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Jan 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EIL05, Inhalation	Experimental		Device: Ectoin Inhalation Solution
Placebo, 0,9% NaCl	Placebo Comparator		Device: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ectoin Inhalation Solution	Device	Once daily inhalation of Ectoin Inhalation Solution	EIL05, Inhalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline and 28 days after treatment start

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Institut für umweltmedizinische Forschung		Düsseldorf		40225	Germany

Label	URL
Website of the Institut für umweltmedizinische Forschung	View source

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided