Acute bronchitis with productive cough i.e. onset of bronchial mucus production with impaired ability to cough up. MedDRA version: 8.1 Level: LLT Classification code 10006452 Term: Bronchitis acute
Conditions
Interventions
Trade Name: Bronchipret® TP
Product Name: Bronchipret® TP
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral
Sponsors
Bionorica AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent obtained - Males and females older than 18 years - Diagnosis of acute bronchitis with productive cough requiring all of the following criteria: • 10 or more coughing fits during daytime (according to the patient’s estimate) • onset of bronchial mucus production with impaired ability to cough up since at maximum 2 days prior to Visit 1 • BSS 5 score points or more (of maximum 20 score points) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Intake of any of the following medications is not allowed: - Previous medication within the last 4 weeks prior to V1: •Immunosuppressives •Systemic antibiotics •Systemic or inhalation glucocorticosteroids - Previous medication within the last 2 weeks prior to V1: •Mucoactive substances - Concomitant medication if started 4 weeks or less prior to Visit 1: •Angiotensin-converting enzyme (ACE) inhibitors - Concomitant medication during the entire study (new prescription): •Systemic antibiotics •Systemic or inhalation glucocorticosteroids •Immunosuppressives •Non-steroidal anti-inflammatory drugs (NSAIDS) •ACE inhibitors •Expectorants/mucoactive drugs •Antitussive drugs (e.g. codein or other morphine derivatives) •Other mucoactive measures (except for steam inhalation) Medical history or presence of any of the following organic diseases: - Chronic bronchitis - Acute episode of chronic bronchitis - Chronic obstructive pulmonary disease (COPD) - Acute episode of COPD - Bronchiectasis - Bronchial asthma - Pneumonia - Mucoviscidosis - Clinically relevant chronic cardiovascular disease - Chronic kidney disease - Gastrointestinal, or liver diseases, such as: •active peptic gastric ulcer •malabsorption •hypersecretion of bile acid •hepatitis - Known hypersensitivity to one or more of the active and / or inactive ingredients of the product - Fever > 39 °C (axillary/orally) - Pregnancy - Lactation - Malignant growth (actual, condition after carcinoma not longer than 5 years without relapse) - Severe somatopathic, neurological and/or psychiatric disease Presence of any of the following conditons: - Parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study. - Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history). - Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study. - Patients in custody by juridicial or official order. - Evidence of an uncooperative attitude. - Patients who have difficulties in understanding the language in which the patient information is given. - antitussive drugs (e.g. codein or other morphine derivates) - other mucuactive measurements (except for steam inhalation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this clinical study is to investigate the efficacy of the herbal medication Bronchipret® TP film coated tablets in adult patients suffering from acute bronchitis and to strengthen the already existing data, which indicate a positive benefit/risk-ratio of the mentioned indication. The primary endpoint of this study is the change in mean frequency of "coughing fits" during daytime documented in the patients diary (starting with getting up in the morning and ending with bedtime) relative to the baseline value of Day 1. The primary endpoint will be calculated by the number of documented coughing fits measured on Day 7, Day 8 and Day 9 in the diary, divided by the number of observed days (3 days). The primary endpoint will be described as: Mean in Coughing fits(Day 7,Day 8, Day 9)/Coughing fits(Day 1) ;Secondary Objective: The assessment of treatment response, the ability to cough up, sputum quality and the relief of symtoms/complaints associated with the respiratory tract infection, as well as general well-being were chosen as secondary efficcy variables. The following nine variables will be evaluated during and at the end of treatment, respectively: 1. Bronchitis Severity Score (BSS) 2. Reduction in coughing fits during the course of treatment calculated by area under the curve (AUC) in coughing fits relative to Day 1 3. Proportion of patients with no coughing fits on Day 9 4. Time to 50% improvement in coughing fits compared to Day 1 5. Ability to cough up during daytime 6. Sleep disturbance due to coughing during the night 7. Patient’s general well-being 8. Response to treatment 9. Sputum quality Tolerability 1. Frequency and intensity of AE 2. Change of vital signe 3. Investigator's and patient's global judgements on tolerability ;Primary end point(s): The primary endpoint of this study is the change in mean frequency of "coughing fits" during daytime documented in the patients diary (starting with getting up in the morning and ending | — |
Countries
Germany
Outcome results
None listed