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

Bitop AG135 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

135

Conditions

Bronchitis Cough Sputum, Cellular Atypia Dyspnoea

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * according to instruction for use Exclusion Criteria: * according to instruction for use

Locations (1)

Facharzt für HNO, Allergologie

Cologne, Germany

Outcomes

Primary Outcomes

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

Time frame: day 7

Secondary Outcomes

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

Time frame: day 14

patients´ evaluation of tolerability (4 point scale)

assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)

Time frame: day7

physicians´ evaluation of tolerability (4 point scale)

assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)

Time frame: 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)

Time frame: 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)

Time frame: day 7

Change in number and type of adverse events

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.