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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bitop AG
ClinicalTrials.gov Identifier:
NCT02632851
First received: December 2, 2015
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
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

Condition
Bronchitis
Cough
Sputum, Cellular Atypia
Dyspnoea

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Non-interventional Multicentric Study on Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution

Resource links provided by NLM:


Further study details as provided by Bitop AG:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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


Enrollment: 135
Study Start Date: December 2015
Study Completion Date: June 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ectoin inhalation solution
treatment according to instructions for use
Pari NaCl inhalation solution (0.9%)
treatment according to instructions for use

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
  Eligibility

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • according to instruction for use

Exclusion Criteria:

  • according to instruction for use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02632851

Locations
Germany
Facharzt für HNO, Allergologie
Cologne, Germany, 50924
Sponsors and Collaborators
Bitop AG
Investigators
Study Chair: R Mösges, Prof Dr University of Cologne
  More Information

Publications:
Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT02632851     History of Changes
Other Study ID Numbers: EIL/aBr/2015
Study First Received: December 2, 2015
Last Updated: June 20, 2016

Keywords provided by Bitop AG:
inhalation
isotonic saline
NaCl solution 0.9 %
Ectoin
bronchitis
respiratory tract infection

Additional relevant MeSH terms:
Infection
Respiratory Aspiration
Bronchitis
Acute Disease
Dyspnea
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Disease Attributes
Signs and Symptoms, Respiratory
Signs and Symptoms
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on March 28, 2017