E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Perennial Allergic Rhinitis |
|
E.1.1.1 | Medical condition in easily understood language |
Perennial Allergic Rhinitis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 |
To assess the safety and tolerability of montelukast 4 mg OG (for 1 to 5 years old) and 5 mg CT (for 6 to 15 years old) for up to 12 weeks of treatment in subjects with PAR.
To conduct a population pharmacokinetic (PPK) analysis based on plasma concentrations of montelukast obtained from subjects with PAR in pediatric aged 1 to 15 years old.
|
|
E.2.2 | Secondary objectives of the trial |
There were no secondary objectives (or hypotheses) for this trial. Exploratory Objective: To assess the efficacy of montelukast by Global Evaluation of PAR by caregiver/subject at Visit 3 and Visit 4 ( for 4 weeks treatment) / at Visit 3, Visit 4 and 6 (for 12 weeks treatment). |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Future Biomedical Research on buccal swab DNA:
Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
|
|
E.3 | Principal inclusion criteria |
Be ≥ 1 y.o. and 15 y.o. ≤ of age on the day of signing informed consent.
Weight: ≥8 kg
Is Male or Female.
Be ambulant patient
Is diagnosed as PAR and has symptom of PAR at Visit 1.
Has allergic rhinitis type classified into “Nasal blocked type” or “combined type” at Visit 2
|
|
E.4 | Principal exclusion criteria |
Is diagnosed as either acute rhinitis*, simple rhinitis, rhinitis Congestive, rhinitis atrophic, Sinusitis with Purulent nasal discharge, Rhinitis medicamentosa, or nonallergic rhinitis (e.g., Vasomotor rhinitis, Eosinophilic rhinitis). *The subject develops acute nasal infections such as acute rhinitis cannot be registered at Visit 2.
Has started hyposensitization therapy or non- specific immunotherapy within 6 month prior to Visit 1 and ongoing.
Has a medical history of inferior concha mucosal resection, submucous resection of inferior Tubinates or other surgery aimed to redaction and/or modulation of nasal mucosa (including electrocoagulation, cryoextraction or application of trichloroacetic acid).
Has a past or present medical history of asthma.
Has total bilirubin ≥ 3.0mg/dl, or AST or ALT ≥ 2.5 X ULN for the institution within 14 days prior to Visit 2.
Treated with other clinical study drug within 3 months prior to Visit1.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability
1) Percentage of subjects with adverse experiences.
2) Change from baseline in laboratory parameters at each time point specified in the study flow chart
Co-Primary endpoint
PPK analysis
AUC, Cmax, Tmax and apparent elimination half-life (t1/2) in each age group
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Treatment Period (Visit 2 to Visit 4[for 4 weeks treatment] / Visit 6[for 12
weeks treatment]) |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |