Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution

NCT ID: NCT02632851

Last Updated: 2016-06-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

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This observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution

Detailed Description

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The assessment focuses on the bronchitis Severity Score (BSS) for standardized use in clinical studies with the outcome criteria of cough, sputum production, rales/rhonchi, chest pain during coughing and dysnoea

Conditions

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Bronchitis Cough Sputum, Cellular Atypia Dyspnoea

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Ectoin inhalation solution

treatment according to instructions for use

No interventions assigned to this group

Pari NaCl inhalation solution (0.9%)

treatment according to instructions for use

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* according to instruction for use

Exclusion Criteria

* according to instruction for use
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitop AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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R Mösges, Prof Dr

Role: STUDY_CHAIR

University of Cologne

Locations

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Facharzt für HNO, Allergologie

Cologne, , Germany

Site Status

Countries

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Germany

References

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Matthys H, Kamin W. Positioning of the Bronchitis Severity Score (BSS) for standardised use in clinical studies. Curr Med Res Opin. 2013 Oct;29(10):1383-90. doi: 10.1185/03007995.2013.832183. Epub 2013 Aug 23.

Reference Type BACKGROUND
PMID: 23927521 (View on PubMed)

Other Identifiers

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EIL/aBr/2015

Identifier Type: -

Identifier Source: org_study_id

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