E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000687 |
E.1.2 | Term | Acute bronchitis |
E.1.2 | System Organ Class | 100000004862 |
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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 |
To evaluate the safety and tolerability of a treatment with EPs® 7630 syrup in comparison to EPs® 7630 solution in patients between 1 and 5 years old suffering from acute bronchitis. |
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E.2.2 | Secondary objectives of the trial |
To analyse the health status during the study course. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient from 1 year to 5 years old.
2. Patient is suffering from acute bronchitis (the patients must have at least two of the three bronchitis-relevant symptoms, i.e. coughing, pulmonary rales at auscultation, and dyspnoea).
3. Patient for whom the legal representatives have given a written informed consent in accordance with the legal requirements.
4. Start of symptoms not longer than 72 hours prior to inclusion into the study |
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E.4 | Principal exclusion criteria |
1. Patient with indication of treatment with antibiotics (e.g. suspected pneumonia)
2. Patient with diagnosed or suspected pneumonia, rhinosinusitis, otitis media, or group
A beta-hemolytic streptococcal (GABHS) tonsillo-pharyngitis
3. Patient with suspicion of foreign body aspiration
4. Known or suspected allergic rhinitis or other allergic diseases
5. History of asthma bronchiale or recurrent bronchitis
6. History of heart, renal, or liver diseases and/or immunosuppression
7. Known or suspected congenital anomalies of heart, kidney, liver, or mental
disabilities
8. Known or suspected hypersensitivity against EPs® 7630 or other excipients of the
investigational products
9. Known or suspected gastro-esophageal reflux disease (GERD)
10. Patient with tendency to bleed, especially nose or gingival bleeding
11. Previous (within the last 6 weeks prior to inclusion into the clinical trial) or
concomitant treatment with anti-coagulants
12. Known or suspected gastrointestinal disorders (e.g. inflammatory bowel disease,
celiac disease, symptomatic lactose intolerance, disbacteriosis, other disorders
associated with diarrhea)
13. Participation in a further clinical trial at the same time or within the last 4 weeks prior
to inclusion into the present study
14. Previous participation in the present clinical study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety:
- frequency, nature and severity of adverse events
- change of vital signs
- changes in laboratory values |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Adverse events will be assessed during the whole treatment period (7 days of treatment).
Changes of vital signs will be assessed on day 7 of the study |
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E.5.2 | Secondary end point(s) |
Patient’s health status:
- Changes in individual respiratory tract infection symptoms related to acute bronchitis as well as the total symptoms score
- Treatment outcome using the Integrative Medicine Outcomes Score (IMOS) as assessed by the investigator as well as by the legal representatives of the patients
- Satisfaction with the treatment using the Integrative Medicine Patient Satisfaction Scale (IMPSS) as assessed by the legal representatives of the patients. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
EPs® 7630 solution vs. EPs® 7630 syrup |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 45 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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Planned Completion (defined as clean data): 30.06.2013
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |