Treatment of allergic rhinitis for pediatric
- Conditions
- Perennial Allergic RhinitisTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-004871-22-Outside-EU/EEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 87
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 87
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method