E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute bronchitis accompanied by coughing |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006452 |
E.1.2 | Term | Bronchitis acute |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
· 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 |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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) 8. participation in a clinical trial during the last two months prior to the individual enrolment of the patient 9. any systemic treatment with antibiotics or any systemic treatment with immunosuppressives within 2 weeks prior to the first administration 10. impossibility to rectally apply suppositories (e.g. due to rectal injuries, rectal bleeding, anal fissures or fistulas, haemorrhoids, perianal inflammation caused by bacterial or fungal infection, bowel diseases) 11. any hints for presence of haemolysis 12. patients or their legal representatives suspected or known not to follow instructions or not to correctly complete a diary 13. patients or their legal representatives who are unable to understand the written and/or verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The symptom rating score assessed by the investigator will serve for determination of the primary variable. Baseline will be sum score assessed on visit 1. Effect of treatment as primary variable will be assessed by comparing baseline values to those obtained during visit 2. The primary outcome measure for efficacy will be the relative change in the symptom score between visits 1 and 2 (i. e. between baseline and after the 6th administration i.e. treatment day 3).
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 80 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
according to the definition given in the protocol |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |