E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute bronchitis with productive cough i.e. onset of bronchial mucus production with impaired ability to cough up. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006452 |
E.1.2 | Term | Bronchitis acute |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | 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 with bedtime) relative to the baseline value of Day 1. The primary endpoint will be calculated by the number of ducumented coughing fits measured on Day 7, Day 8 and Day 9 in the diary, divided by the number of observed days (3 days). Due to the need to adjust for the influence of the baseline value (higher baseline values lead with a high probability to higher values on Day 7, Day 8 and Day 9), this mean value will be divided through the baseline value (Day 1) for each patient. Thus the primary endpoint will be described: Mean in Coughing fits(Day 7, Day 8, Day 9)/Coughing fits(Day 1) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 31 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be february 2007 at last patient out of alltogether 360 enrolled patients. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |