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

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ClinicalTrials.gov Identifier: NCT02632851
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Bitop AG

December 2, 2015
December 17, 2015
June 21, 2016
December 2015
May 2016   (Final data collection date for primary outcome measure)
Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale) [ Time Frame: 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

Same as current
Complete list of historical versions of study NCT02632851 on ClinicalTrials.gov Archive Site
  • Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale) [ Time Frame: 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) [ Time Frame: day7 ]
    assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)
  • physicians´ evaluation of tolerability (4 point scale) [ Time Frame: day 7 ]
    assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)
  • patients´ evaluation of efficacy (five point IMOS scale) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: day 7 ]
    incidence of adverse events and correlation with the therapy
Same as current
Not Provided
Not Provided
 
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
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
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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
  • Bronchitis
  • Cough
  • Sputum, Cellular Atypia
  • Dyspnoea
Not Provided
  • Ectoin inhalation solution
    treatment according to instructions for use
  • Pari NaCl inhalation solution (0.9%)
    treatment according to instructions for use
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
120
June 2016
May 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • according to instruction for use

Exclusion Criteria:

  • according to instruction for use
Sexes Eligible for Study: All
5 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02632851
EIL/aBr/2015
Yes
Not Provided
Not Provided
Bitop AG
Bitop AG
Not Provided
Study Chair: R Mösges, Prof Dr University of Cologne
Bitop AG
June 2016