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

NCT02632851 | Completed DMC

• 1 other identifier: EIL/aBr/2015
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchitis; Cough; Sputum, Cellular Atypia; Dyspnoea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale)

  day 14

• patients´ evaluation of tolerability (4 point scale)

  day7

• physicians´ evaluation of tolerability (4 point scale)

  day 7

• patients´ evaluation of efficacy (five point IMOS scale)

  day 7

• physicians´ evaluation of efficacy (five point IMOS scale)

  day 7

Study Arms (2)

Ectoin inhalation solution

treatment according to instructions for use

Pari NaCl inhalation solution (0.9%)

treatment according to instructions for use

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• according to instruction for use

You may not qualify if:

• according to instruction for use

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

Facharzt für HNO, Allergologie

Cologne, 50924, Germany

Location

Related 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.

  PMID: 23927521 BACKGROUND

MeSH Terms

Conditions

Bronchitis; Cough; Dyspnea; Respiratory Aspiration; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• R Mösges, Prof Dr

  University of Cologne

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2016-06

Locations

DE (1)