MedDRA - 10023011 MedDRA - 10011224
Conditions
Interventions
Group 1: Intake of junior-angin N SIRUP
Group 2: Application of Klosterfrau Reizhusten Lutschtabletten Orange N
Sponsors
MCM Klosterfrau Vertriebsgesellschaft mbH
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Children from 2 years and adolescents (junior-angin N SIRUP); 2. Children from 6 years, adolescents and adults (Klosterfrau Reizhusten Lutschtabletten Orange N); 3. Presence of dry, unproductive cough as a symptom of an acute infection of the upper respiratory tract or other irritation causing conditions since = 48 hour; 4. Satisfactory general health status except for the cough/upper respiratory infection according to the assessment of the investigator; 5. Written informed consent (for minors also from one/both parent(s)); 6. Willingness to comply with intake specifications of the medical device, the study procedures and completion of the patient diary; 7. Confirmed diagnosis justifying the application of the medical device for the treatment of the complaints.
Exclusion criteria
Exclusion criteria: 1. Children younger than 2 years and adults (junior-angin N SIRUP); 2. Children younger than 6 years (Klosterfrau Reizhusten Lutschtabletten Orange N); 3. Pregnant or breastfeeding women; 4. Known allergy/hypersensitivity against one of the ingredients; 5. Presence of a contraindication as listed in the instructions for use; 6. Presence of any sign for a bacterial infection requiring treatment with systemic antibiotics; 7. Patients suffering from tuberculosis, bronchial asthma, known malignancies of the lung or bronchi, chronic obstructive pulmonary disease, severe respiratory failure (cyanosis, need for respiratory support) or other pathologies of the lung at the time of enrollment; 8. Parallel participation or planned parallel participation in clinical investigation or observational studies; 9. Earlier participation in this PMCF-study; 10. Adults (patients and legal representative) with limited legal competence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Observation of disease-related symptom/intensity change in the course of Treatment; 2. Global assessment of effectiveness of the treatment by the patient/physician. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Onset of effectiveness after the first application; 2. Incidence of AEs; 3. Global assessment of tolerability of the treatment by the patient/physician; 4. Compliance of the applicants with the therapy; 5. Global assessment of taste. | — |
Countries
Germany
Contacts
Public ContactUdo Schäfer
HNO-Praxis Dr. med. Schäfer
Outcome results
None listed