Trial to evaluate the efficacy and safety of 2 Prospan® posologies (2x 7.5 ml and 3x 5 ml) vs. Placebo in the treatment of acute bronchitis

Phase 1

• Conditions: Acute bronchitis; MedDRA version: 19.0Level: LLTClassification code 10000687Term: Acute bronchitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-002426-37-DE
• Lead Sponsor: Engelhard Arzneimittel GmbH & Co.KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-08
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

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

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

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.

Study & Design

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