Severe acute bronchitis with or without associated common cold MedDRA version: 20.1 Level: LLT Classification code 10000687 Term: Acute bronchitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Soledum® Kapseln 100 mg
Pharmaceutical Form: Gastro-resistant capsule, soft
INN or Proposed INN: cineole
CAS Number: 470-82-6
Other descriptive name: CINEOLE
Concentration unit: mg milligr
Sponsors
Cassella-med GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years 2. Acute bronchitis since = 48 hours, with or without associated common cold 3. Women of childbearing potential are allowed only with negative pregnancy test and effective contraception 4. Subjects able to follow the instructions given by the investigator 5. Signed informed consent 6. BSS > 12, indicating severe or very severe bronchitis. 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 205 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Chronic bronchitis (WHO Definition) and chronic obstructive pulmonary disease (COPD) 2. Bronchial asthma 3. Allergic rhinitis 4. Chronic rhinitis with or without nasal polyp(s) 5. Cystic fibrosis 6. Pneumonia and/or indication for treatment with antibiotics 7. Pertussis and/or pseudo-croup 8. Subjects treated with antibiotics, glucocorticosteroids (systemic or per inhalation), ß2-mimetics, theophylline, expectorants/mucolytics, antitussives, cineole, or other etheric oils (systemic or per inhalation) within 7 days prior to study start or at the time of study start 9. Known hypersensitivity to cineole or any of the other compounds of Soledum® Kapseln/ Soledum® Kapseln forte 10. Known serious concomitant disease that can influence the course of the bronchitis 11. Clinically relevant renal and/or liver diseases 12. Smoking at the time of enrolment into the trial or in the last 6 months prior to the enrolment into the trial 13. Immunosuppressive states, e.g. malignancy, autoimmune diseases, AIDS 14. Pregnancy, lactation. Women without reliable contraception 15. Dependency from alcohol or drugs 16. Insufficient knowledge of local language endangering compliance 17. Subjects participating in another study or who participated in clinical studies within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the dose-response behaviour of 600 mg, 900 mg and 1200 mg cineole in subjects with severe acute bronchitis with or without associated common cold.;Secondary Objective: Secondary objectives are the efficacy and safety of 3 different doses of cineole compared with placebo in the treatment of severe acute bronchitis.;Primary end point(s): The primary efficacy variable is the sum score of the Bronchitis Severity Scale (BSS) taking into account the change/course of the sum score from start of treatment (Study Day 1) until Study Day 5 and Study Day 8. The BSS comprises the following criteria: cough, sputum production (expectoration), rales/rhonchi, chest pain when coughing and dyspnoea. Each of these 5 criteria is to be assessed by the investigator on a 5-step rating scale with the following steps: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The BSS sum score is the sum of the scores for each of the 5 criteria. ;Timepoint(s) of evaluation of this end point: Study Days 1, 5 and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables are: - The course of the scores for each of the individual criteria of the BSS (which are cough, sputum production (expectoration), rales/rhonchi, chest pain when coughing and dyspnoea) from start of treatment (Study Day 1) until Study Day 5 and Study Day 8. The criterion rales/rhonchi can be assessed only based on auscultation. Therefore this criterion is assessed by investigator, but not by the subject. Hence, the individual criteria of the BSS assessed by the subject include cough, sputum production (expectoration), chest pain when coughing and dyspnoea. - Complete remission: a BSS sum score of = 2: A sum score of the BSS = 2 assessed by the investigator indicates complete remission. - Severity of cough measured on a 100 mm Visual Analogue Scale (VAS) (ranging from 0 mm = no cough to 100 mm = worst cough ever) every day from inclusion (Study Day 1) to Study Day 8 - Body temperature (measured with ear thermometer) assessed by the investigator at inclusion (Study Day 1) and Study Day 8 and assessed by the subject every day from Study Day 2 to Study Day 7, inclusively - Treatment failure: hospitalisation due to worsening of bronchitis and / or prescription and subsequent use of any available product for bronchitis/sinusitis/common cold - Use of antibiotics - Assessment of the efficacy of the study medication by investigator and by subject on a verbal rating scale: 3 = very good, 2 = good, 1 = satisfactory, 0 = bad - Use of rescue medication Safety Assessment: - Adverse events - General physical examination at inclusion and at Study Day 8 - Laboratory parameters: Haematology including erythrocyte count, platelet count, white blood cell count with differential white blood cell count (WBC), liver panel with gamma-glutamyl transferase (GGT), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (ALP), creatinine, C-reactive protein (CRP), vitamin D (25OH). - Assessment | — |
Countries
Germany
Contacts
Public ContactClinical Operations
Cassella-med GmbH & Co. KG
Outcome results
None listed