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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02632851

Enrollment

135

Registered

2015-12-17

Start date

2015-12-31

Completion date

2016-06-30

Last updated

2016-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchitis, Cough, Dyspnoea, Sputum, Cellular Atypia

Keywords

inhalation, isotonic saline, NaCl solution 0.9 %, Ectoin, bronchitis, respiratory tract infection

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

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Inclusion criteria

* according to instruction for use

Exclusion criteria

* according to instruction for use

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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
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
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)

Countries

Germany

Outcome results