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

Study Overview
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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

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

Conditions
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Bronchitis, Cough, Sputum, Cellular Atypia, Dyspnoea

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: according to instruction for use Exclusion Criteria: according to instruction for use

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ectoin inhalation solution<br>treatment according to instructions for use | |
| Pari NaCl inhalation solution (0.9%)<br>treatment according to instructions for use | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale) | 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) | 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) | assessment of tolerability on a 4 point scale (bad, satisfied, good, very good) | day7 | 
| physicians´ evaluation of tolerability (4 point scale) | assessment of tolerability on a 4 point scale (bad, satisfied, good, very good) | day 7 | 
| patients´ evaluation of efficacy (five point IMOS scale) | 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) | 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 | incidence of adverse events and correlation with the therapy | day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhalation, isotonic saline, NaCl solution 0.9 %, Ectoin, bronchitis, respiratory tract infection