RCT to Evaluate the Efficacy and Safety of Ivy Leaves Cough Liquid vs. Placebo in the Treatment of Acute Cough

Engelhard Arzneimittel

Status and phase: Completed; Phase 2

Conditions: Acute Cough

Treatments: Drug: Placebo; Drug: Ivy Leaves Cough Liquid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02396706

EA-14-01-077

Details and patient eligibility

About

Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough

Enrollment: 181 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion 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

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. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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181 participants in 2 patient groups, including a placebo group

Ivy Leaves Cough Liquid

Active Comparator group

Description:

Ivy Leaves Cough Liquid

Treatment:

Drug: Ivy Leaves Cough Liquid

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo