acute bronchitis MedDRA version: 13.1 Level: LLT Classification code 10000687 Term: Acute bronchitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: GeloMyrtol forte
Product Name: SIA capsules
Product Code: N/A
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: 6096046.00.00
CAS Number: 0
Current Sponsor code: P1001GF
Other descri
Sponsors
G. Pohl-Boskamp GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: 1. Prohibited previous and concomitant medication (see below) 2. Medical history or presence of the following respiratory diseases: - Recent upper respiratory tract infection ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: To assess the safety and tolerability of two weeks treatment with SIA capsules compared to placebo.;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). | — |
Countries
Germany
Contacts
Public ContactAstrid Clausen Project Manager
Pharmalog Institut für klinische Forschung GmbH
Outcome results
None listed