E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 |
Mean difference of a defined total bronchitis severity score (BSS) of 25% between the verum group and the placebo group after 7 days of full medication dose |
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E.2.2 | Secondary objectives of the trial |
- Mean difference of a defined total bronchitis severity score (BSS) of 25% between the verum group and the placebo group after 10 days of full medication dose - Global impact of disease on QOL as assessed by patient after 7 and 10 days of full medication dose - Adverse event rate
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adults of both genders from ≥ 18 - 75 years 2. Broca-index between 0.75 and 1.30 3. Clinical diagnosis of acute bronchitis: o ≥ 10 coughing fits during the last day prior to screening visit o Baseline Bronchitis Severity Score (BSS) ≥ 5 points ( of max. 20 points) o Onset of first symptoms within 2 days before start of treatment 4. Informed consent and willingness to comply with the protocol
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E.4 | Principal exclusion criteria |
- History or presence of confounding respiratory disease: • Upper respiratory tract infection within the last 4 weeks • Chronic bronchitis • COPD • Acute exacerbations thereof bronchiectasis, asthma, suspected pneumonia, cystic fibrosis, lung cancer - Active cigarette smoking > 10/day - Concomitant bacterial infection - Elevated body temperature (> 39,5°C rectally or > 39,0°C axillary or otic) - Malignant disease of any origin - Known or suspected hypersensitivity to the active substance and/or to any of the excipients - Need for antibiotic treatment in patients at high risk of serious complications because of pre-existing comorbidity, including significant heart, lung, renal, liver or neuromuscular disease, immunosuppression, cystic fibrosis, human immunodeficiency virus infection, malignancy other than squamous or basal cell carcinoma of the skin. - Antibiotic therapy (local or systemic) at any time during the preceding four weeks - Need for application of concomitant local medications including antibiotics, corticosteroids, antihistaminic agents - Immunosuppressive therapy and/or systemic or inhalative glycocorticosteroids - antiotensin converting enzyme (ACE) inhibitors - Systemic antihistaminic agents - secrelytica, mucolytics, expectorants, and bronchodilatatory agents - Radiation therapy or chemotherapy within the previous 12 months - Pregnancy or breastfeeding - History of alcohol or drug abuse likely to lead to uncooperative behaviour - History of psychiatric and/or neurological illness likely to lead to uncooperative behavior - Participation in a clinical research study within the last 6 weeks - Evidence or suspicion of non-compliance - Inability to provide informed consent - Patients using medication for treatment of common cold like symptoms
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean difference of a defined total bronchitis severity score (BSS) of 25% between the verum group and the placebo group after 7 days of full medication dose |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 7 days of full medication dose |
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E.5.2 | Secondary end point(s) |
- Mean difference of a defined total bronchitis severity score (BSS) of 25% between the verum group and the placebo group after 10 days of full medication dose - Global impact of disease on QOL as assessed by patient after 7 and 10 days of full medication dose - Adverse event rate |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at baseline, after 7 and 10 days of full medication dose |
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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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 20 |
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 | No |
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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Final assessment (day 10 or at any time in case of discontinuation of treatment) - Reason for discontinuation of therapy - Assessment of failures - Assessment of compliance
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |