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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ectoin inhalation solution | treatment according to instructions for use | ||
| Pari NaCl inhalation solution (0.9%) | treatment according to instructions for use |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| R Mösges, Prof Dr | University of Cologne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facharzt für HNO, Allergologie | Cologne | 50924 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23927521 | Background | 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. |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D003371 | Cough |
| D004417 | Dyspnea |
| D053120 | Respiratory Aspiration |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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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 |
| D008171 |
| Lung Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |