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 |
It is a transient and self-limited condition caused by an inflammation of the mucous membrane that lines the air passages of the lower airways. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000687 |
E.1.2 | Term | Acute bronchitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
To compare the effect of SIA capsules versus placebo during a two-week treatment period (300 mg four times a day [q.i.d.]) in adult patients with acute bronchitis. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of two weeks treatment with SIA capsules compared to placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. A signed and dated written informed consent and data protection declaration 2. Male and female outpatients 3. Race: Caucasian 4. Age: ³ 18 years 5. Weight: Broca Index 0.75 – 1.30 6. Clinical diagnosis of acute bronchitis as characterized by: - ≥ 10 coughing fits during the last day prior to Visit 1 (according to patient´s estimate) - Baseline Bronchitis Severity Score (BSS) ≥ 5 points (of maximum 20 points) - Onset of first symptoms (bronchial mucus production with impaired ability to cough up) within two days before treatment initiation.
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E.4 | Principal exclusion criteria |
1. Prohibited previous and concomitant medication (see below) 2. Medical history or presence of the following respiratory diseases: - Recent upper respiratory tract infection (< 4 weeks) - Chronic bronchitis or acute exacerbations of chronic bronchitis - Chronic obstructive pulmonary disease (COPD) or acute exacerbation of COPD - Bronchiectasis - Bronchial asthma - Suspected Pneumonia - Mucoviscidosis - Lung cancer (except other malignancies, if they are in remission ³ 5 years) 3. Concomitant bacterial infection 4. Body temperature > 39.5°C rectal or >39.0°C axillary or otic 5. Tobacco smoking > 1 pack of cigarettes per day 6. Known hypersensitivity to one or more of the active and / or inactive ingredients of the product (e.g. eucalyptus oil, sweet orange oil, myrtle oil, lemon oil or cineole, cineole [the main constituent of eucalyptus oil]) 7. Inflammatory gastrointestinal or hepatic disease or inflammation of the gallbladder or bile duct 8. History or presence of clinically relevant cardiovascular, renal, metabolic, haematological, dermatologic, neurological, psychiatric, systemic or infectious disease 9. Any other comorbidity is only allowed if it does not interfere with the eligibility criteria and the evaluation of the study endpoints 10. Pregnant or breastfeeding women 11. Women of childbearing potential without highly effective contraception (failure rate less than 1%) 12. Current participation in a research study involving an investigational product or within the last 6 weeks 13. Previous participation in this clinical study 14. 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) 15. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study 16. Patients in custody by juridical or official order 17. Evidence of an uncooperative attitude (non-compliance) 18. Patients who have difficulties in understanding the language in which the patient information is given 19. Patients who do not agree to the transmission of their pseudonymous data within the liability of documentation and notification Not permitted within 4 weeks before Visit 1 · Antibiotics · Systemic or inhalation glucocorticosteroids · Start of angiotensin converting enzymes (ACE) inhibitors Not permitted within 2 calendar days before Visit 1: · Secretolytics, mucolytics, and antitussive drugs (e.g. codeine or other morphine derivatives) Not permitted from Visit 1 to Visit 4: · Any inhalation and / or physical therapy of acute bronchitis · Expectorants / mucoactive drugs · Antitussive drugs (e.g. codeine or other morphine derivatives) · Analgesics (except paracetamol) · Sedatives / hypnotics or sedating antihistamines · Systemic antibiotics · Systemic or inhalation corticosteroids · Medications causing cough: - ACE inhibitors - Angiotensin II receptor antagonists (e.g. valsartan, losartan) - Antiarrhythmic (e.g. amiodaron) - Inhaled bronchodilators, such as beta 2-agonists (e.g. salmeterol) and inhaled anticholinergics (e.g. ipratropium bromide) - Inhaled corticosteroids (e.g. budesonide) - Inhaled chromoglycate
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E.5 End points |
E.5.1 | Primary end point(s) |
13.1 Primary efficacy endpoint: Mean in coughing fits(Day 7, Day 8, Day 9) / coughing fits(Day 1) The coughing fits counted by the patients on Day 7, Day 8 and Day 9 (starting with getting up in the morning and ending with bedtime) will be 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 (standardized to the first day of patient’s precise recording with a manual counter). |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 33 |
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 | No |
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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please see study protocol |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |