E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Bacterial Rhinosinusitis |
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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] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
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 |
The primary objective of this study was to assess clinical efficacy of CVA/AMPC 1:14 combination
[CVA/AMPC (1:14)] administered in children with acute bacterial rhinosinusitis (ABRS). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study were to assess bacteriological efficacy and safety of
CVA/AMPC (1:14) administered in children with ABRS. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female children aged from 3 months to less than 15 years, 6 to less than 40 kg of body weight
who met criteria described below.
• Children with ABRS with inflammation as bacterial infection who has the following
symptoms/signs on the start date of study treatment or the day before.
1) Redness of the nasal mucosa
2) Purulent or mucopurulent nasal or postnasal discharge
3) Pathological shadow in the paranasal sinus on a radiogram (only for reference). Subject with a
surgical history should be excluded but subject with a pervious surgery more than 365 days
before and apparently preserved maxillary sinus mucosa or subject with a previous surgery of
nasal polypectomy more than 90 days before may be enrolled in the study.
• Children with ABRS classified as moderate or severe (Total score >= 4) based on the nasal
cavity findings and symptoms shown below:
Rhinnorhoea
Bad mood/productive cough
Nasal/postnasal discharge |
|
E.4 | Principal exclusion criteria |
Subject with a
surgical history should be excluded but subject with a pervious surgery more than 365 days
before and apparently preserved maxillary sinus mucosa or subject with a previous surgery of
nasal polypectomy more than 90 days before may be enrolled in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical outcome at Test of Cure |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Efficacy
1. Clinical outcome at End of Treatment
2. Bacteriological outcome
3. Severity assessment of symptoms and nasal cavity findings
Safety
1. All adverse events experienced
2. Clinical laboratory parameters (hematology and clinical chemistry)
Others
1. Overall acceptability of medication
2. Treatment compliance
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy
1. Day 8
2. Day 1 and 8
3. Day 1, 4, 8 and 15
Safety
1. From Day 1 to Day 15
2. Day 1 and 8
Others
1. Day 8
2. From Day 1 to 8 |
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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 | No |
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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 7 |