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

June 20, 2016 updated by: Bitop AG

Non-interventional Multicentric Study on Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50924
        • Facharzt für HNO, Allergologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care or ENT units study the therapeutic process in this obvservational trial in total of 120 patients suffering on respiratory tract infection and/or acute bronchitis

Description

Inclusion Criteria:

  • according to instruction for use

Exclusion Criteria:

  • according to instruction for use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Ectoin inhalation solution
treatment according to instructions for use
Pari NaCl inhalation solution (0.9%)
treatment according to instructions for use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale)
Time Frame: day 7

Assessment of bronchits severity score on a 5 point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration) of symptoms:

Cough, sputum production, rales/rhonchi, chest pain during coughing, dyspnoea
day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale)
Time Frame: day 14

Assessment of bronchits symptoms on a 5 point scale (absent, mild, moderate, severe, very severe) of symptoms:

Cough, sputum production, rales/rhonchi, chest pain during coughing, dyspnoea
day 14
patients´ evaluation of tolerability (4 point scale)
Time Frame: day7
assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)
day7
physicians´ evaluation of tolerability (4 point scale)
Time Frame: day 7
assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)
day 7
patients´ evaluation of efficacy (five point IMOS scale)
Time Frame: day 7
assessment of tolerability on a five point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration)
day 7
physicians´ evaluation of efficacy (five point IMOS scale)
Time Frame: day 7
assessment of tolerability on a five point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration)
day 7
Change in number and type of adverse events
Time Frame: day 7
incidence of adverse events and correlation with the therapy
day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitop AG

Investigators

  • Study Chair: R Mösges, Prof Dr, University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIL/aBr/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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