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Completed

NCT Number: NCT02632851

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

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Key information

Conditions

Bronchitis Bronchial Diseases Cough Dyspnea Dyspnoea Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Sputum, Cellular Atypia

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Facharzt für HNO, Allergologie

Cologne, 50924, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • according to instruction for use

Exclusion criteria

  • according to instruction for use

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. patients´ evaluation of tolerability (4 point scale)

    Time frame: day7

    assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)

  3. physicians´ evaluation of tolerability (4 point scale)

    Time frame: day 7

    assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)

  4. 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)

  5. 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)

  6. Change in number and type of adverse events

    Time frame: day 7

    incidence of adverse events and correlation with the therapy

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2015
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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