Randomized, prospective double-blinded study to evaluate safety and efficacy of Angocin Anti-Infekt N versus placebo in the prophylaxis of respiratory tract infections - AngoPA

Conditions: Prophylaxis of respiratory tract infections
MedDRA version: 12.1Level: LLTClassification code 10066740Term: Acute respiratory tract infection

Registration Number: EUCTR2010-023227-26-DE

Lead Sponsor: Repha GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Adult volunteers of both sexes who have suffered in the previous cold season at least 2 acute infection of the respiratory tract,
subjects aged 18 to 75 years,
signed ICF (informed consent form)

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

serious chronic diseases,
serious diseases of the psyche,
known hypersensitivity to any of the components of the study medication,
simultaneous participation in a clinical study or participation in a clinical trial within the previous 30 days before enrollment,
pregnant women, nursing mothers or women planning a pregnancy, women of childbearing age who operate no adequate contraception,
subjects with a disease or in a situation that exposed the opinion of the investigator the subjects a significant risk of prejudice the study results or influence them significantly,
abnormal laboratory values,
taking antibiotics within 3 weeks prior to study implementation,
chronic infections of the respiratory tract,
allergic rhinitis,
influenza and pneumonia vaccine during the study
alcohol and drug abuses
previous participation in a study within the last 30 days
pregnancy and lactation
known hypersensitivity of one of the ingredients of the IMP and placebo

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Number of subjects with a respiratory tract infection during prophylactic administration within the three groups;Secondary Objective: Kind of infection, intensity of the infection and duration of the infection that occurs within the trial;Primary end point(s): The change of the number of subjects with a respiratory tract infection from the beginning to the end of the study in the three application groups.

Secondary Outcome Measures