A study of the effectiveness and safety of Cineole in patients suffering from severe bronchitis with or without associated common cold

Phase 1

• Conditions: Severe acute bronchitis with or without associated common cold; MedDRA version: 20.1Level: LLTClassification code 10000687Term: Acute bronchitisSystem Organ Class: 100000004862; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2017-003044-20-DE
• Lead Sponsor: Cassella-med GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-24
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified