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

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632851
• Other study ID #: EIL/aBr/2015
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: June 20, 2016
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• according to instruction for use

Exclusion Criteria:

• according to instruction for use

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchitis
• Cough
• Dyspnoea
• Respiratory Tract Infections
• Sputum, Cellular Atypia

Locations

Country	Name	City	State
Germany	Facharzt für HNO, Allergologie	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	patients´ evaluation of tolerability (4 point scale)	assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)	day7	No
Secondary	physicians´ evaluation of tolerability (4 point scale)	assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)	day 7	No
Secondary	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	No
Secondary	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	No
Secondary	Change in number and type of adverse events	incidence of adverse events and correlation with the therapy	day 7	Yes