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

Completed

• Conditions: Cough; Sputum, Cellular Atypia; Dyspnoea; Bronchitis

• Registration Number: NCT02632851
• Lead Sponsor: Bitop AG

Brief Summary

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

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-17
• Primary Completion: 2016-05
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-20
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• according to instruction for use

Exclusion Criteria

• according to instruction for use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale)	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

Secondary Outcome Measures

Name	Time	Method
Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale)	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
patients´ evaluation of tolerability (4 point scale)	day7	assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)
physicians´ evaluation of tolerability (4 point scale)	day 7	assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)
patients´ evaluation of efficacy (five point IMOS scale)	day 7	assessment of tolerability on a five point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration)
physicians´ evaluation of efficacy (five point IMOS scale)	day 7	assessment of tolerability on a five point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration)
Change in number and type of adverse events	day 7	incidence of adverse events and correlation with the therapy

Trial Locations

Locations (1)

Facharzt für HNO, Allergologie; 🇩🇪 Cologne, Germany