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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 2, 2015
First Posted Date December 17, 2015
Last Update Posted Date June 21, 2016
Study Start Date December 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2015)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02632851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 14, 2015)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
Official Title Non-interventional Multicentric Study on Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
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
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Bronchitis
  • Cough
  • Sputum, Cellular Atypia
  • Dyspnoea
Intervention Not Provided
Study Groups/Cohorts
  • Ectoin inhalation solution
    treatment according to instructions for use
  • Pari NaCl inhalation solution (0.9%)
    treatment according to instructions for use
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2016)
135
Original Estimated Enrollment
 (submitted: December 14, 2015)
120
Actual Study Completion Date June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • according to instruction for use

Exclusion Criteria:

  • according to instruction for use
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02632851
Other Study ID Numbers EIL/aBr/2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bitop AG
Study Sponsor Bitop AG
Collaborators Not Provided
Investigators
Study Chair: R Mösges, Prof Dr University of Cologne
PRS Account Bitop AG
Verification Date June 2016