Trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough
- Conditions
- Acute coughMedDRA version: 17.1Level: LLTClassification code 10066522Term: Acute coughSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-003590-41-DE
- Lead Sponsor
- Engelhard Arzneimittel GmbH & Co.KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects eligible for inclusion in this trial must fulfill all of the following criteria:
1. Acute cough with symptoms lasting 2-3 days 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 cough 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. Acute 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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Subjects eligible for inclusion in this trial must not fulfill any of the following 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. 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.
11. 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.
12. Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Ivy leaves Cough Liquid compared with placebo applied three times a day in subjects with acute cough, in particular with regard to cough severity (CS). ;Secondary Objective: - Difference of the Bronchitis Severity Score (BSS) assessed between V1 and each of the visits V2, V3, V4 and V5 <br>- CS on VAS over the whole observation period (AUC over 14 days, V1, V2, V3, V4, V5 and V6)<br>- CS on Verbal Category Descriptive Score (VCD) over the whole treatment period (AUC over 7 days, V1, V2, V3, V4 and V5)<br>- Global efficacy assessment at V5 and V6 <br>- Safety of Ivy leaves Cough Liquid compared with placebo applied three times a day over the whole treatment period (7 days, V1, V2, V3, V4 and V5). <br>;Primary end point(s): The primary efficacy outcome is CS assessed by Visual Analogue Scale (VAS) over the whole treatment period (area under the curve (AUC)) ;Timepoint(s) of evaluation of this end point: 7 days, V1, V2, V3, V4 and V5
- Secondary Outcome Measures
Name Time Method Secondary end point(s): a) Difference of the Bronchitis Severity Score (BSS) <br>b) CS on VAS over the whole observation period <br>c) CS on Verbal Category Descriptive Score (VCD) over the whole treatment period (AUC)<br>d) Global efficacy assessment <br>e) Safety of Ivy leaves Cough Liquid compared with placebo applied three times a day over the whole treatment period <br>;Timepoint(s) of evaluation of this end point: a) between V1 and each of the visits V2, V3, V4 and V5 <br>b) over 14 days, V1, V2, V3, V4, V5 and V6<br>c) over 7 days, V1, V2, V3, V4 and V5)<br>d) V5 and V6 <br>e) 7 days, V1, V2, V3, V4 and V5