Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The aims of this study are

• Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing

• Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Engelhard Arzneimittel GmbH & Co.KG

Criteria

Inclusion Criteria:

1. male or female children aged 0 to 6 years

2. acute bronchitis existing not longer than three days and accompanied by coughing

3. symptom rating score of ≥ 5 assessed by the investigator

4. symptom 'frequency of coughing' of ≥ 2 assessed by the investigator

5. the patient's legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study -

Exclusion Criteria:

1. hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations

2. patients with severe allergies or multiple drug allergies

3. any other pulmonary disease within the last two weeks

4. chronic pulmonary diseases

5. exacerbation of chronic pulmonary disease

6. suspicion of bacterial pulmonary infection

7. fever above 39°C (rectal measurement) -