Acute bronchitis MedDRA version: 19.0 Level: LLT Classification code 10000687 Term: Acute bronchitis System Organ Class: 100000004862
Conditions
Sponsors
Engelhard Arzneimittel GmbH & Co.KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Acute bronchitis with symptoms lasting 48 to 72 hours prior to treatment 2) Men or women of any ethnic origin 3) Age 18 to 75 years 4) Subjects who are able to understand and are willing to comply to trial instructions 5) Having given written informed consent 6) Satisfactory health except for the bronchitis as determined by the investigator based on medical history and physical examination 7) CS score of at least 50 mm on a 100 mm VAS at V1 8) BSS of at least 10 points at V1 9) VCD score of at least 2 points at V1 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 193 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 1) Allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease 2) History of hypersensitivity to any excipient of the applied drugs 3) History of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever 4) History of chronic gastritis or peptic ulcers 5) Any gastrointestinal complaints within 7 days before V1 6) Participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly 7) Treatment with corticoids, beta-2 agonists (e.g. salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, angiotensin-converting enzyme (ACE) inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate or homeopathic drugs against common cold within 7 days before V1 8) Drug or alcohol abuse in the opinion of the investigator 9) Pregnant or nursing (lactating) women 10) Body temperature >38.3°C 11) Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as: • Surgical sterilization • Hormonal contraception • Intra-Uterine Device (IUD) • Double barrier method • Total abstinence throughout the trial at the discretion of the investigator Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the trial. A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child-bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. 12) Subjects with significant diseases, defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject’s ability to participate in the trial; includes subjects with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease. 13) Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the efficacy and safety of two different doses of ivy leaves cough liquid with placebo in the treatment of acute bronchitis. The primary variable is the assessment of severity of bronchitis using BSS (Bronchitis Severity Score);Secondary Objective: - Difference of the BSS assessed over the whole observation period - Difference of the BSS between V1 and V5 with regard to ivy leaves cough liquid vs. placebo each in the dosage 3x5ml - Difference of the BSS between V1 and V5 with regard to ivy leaves cough liquid vs. placebo each in the dosage 2x7,5ml - Difference of the BSS between V1 and V5 with regard to verum applied 3x5ml vs. verum applied 2x7,5ml daily - Difference of the CS assessed on Visual Analogue Scale (VAS) over the whole observation period - Difference of the CS assessed by the Verbal Category Descriptive Score (VCD) over the whole observation period - Change of spirometrical values (FEV1, FVC, FEV1/FVC%) between V1 and each of the visits V2, V5 and V6 - Global efficacy and tolerability assessment at V5 and V6 - Safety of ivy leaves cough liquid compared with placebo over the whole treatment period;Primary end point(s): The primary efficacy outcome is the change of CS assessed by the Bronchitis Severity Score (BSS) between V1 and V5 with regard to pooled vera vs. pooled placebo.;Timepoint(s) of evaluation of this end point: 2 days, V1 and V5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference of the BSS assessed over the whole observation period (between V1 and each of the visits V2, V3, V4, V5 and V6) 2. Difference of the BSS between V1 and V5 with regard to ivy leaves cough liquid vs. placebo each in the dosage 3x5 mL 3. Difference of the BSS between V1 and V5 with regard to ivy leaves cough liquid vs. placebo each in the dosage 2x7.5 mL 4. Difference of the BSS between V1 and V5 with regard to verum applied 3x5 mL vs. verum applied 2x7.5 mL daily 5. CS assessed on Visual Analogue Scale (VAS) over the whole treatment period (area under the curve (AUC) over 7 days, V1 V2, V3, V4 and V5) 6. Difference of the CS assessed by the Verbal Category Descriptive Score (VCD) over the whole observation period (between V1 and each of the visits V2, V3, V4, V5 and V6) 7. Change of spirometrical values (FEV1, FVC, FEV1/FVC%) between V1 and each of the visits V2, V5 and V6 8. Global efficacy and tolerability assessment at V5 and V6 9. Safety of ivy leaves cough liquid compared with placebo over the whole treatment period (7 days, V1, V2, V3, V4 and V5).;Timepoint(s) of evaluation of this end point: 1. 14 days: V1, V2, V3, V4, V5 and V6 2. 2 days: V1 and V5 3. 2 days: V1 and V5 4. 2 days: V1 and V5 5. 7 days: V1, V2, V3, V4 and V5 6. 14 days: V1, V2, V3, V4, V5 and V6 7. 4 days: V1, V2, V5 and V6 8. 2 days: V5 and V6 9. 7 days: V1, V2, V3, V4 and V5 | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Dr. Bruno Giannetti
Clinsearch GmbH
Outcome results
None listed