Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis.
Detailed description
* double-blind, non-inferiority, prospective, parallel group trial. * Experiment duration: 07 days. * 02 visits (days 0 and 7). * Efficacy will be evaluated for persistent allergic rhinitis based on nasal symptoms score * Adverse events evaluation.
Interventions
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Consent of the patient or legal guardian; * Clinical diagnosis of moderate - severe persistent allergic rhinitis according to the classification of ARIA (Allergic Rhinitis and Its Impact on Asthma); * Children aged between 2 and 11 years and 11 months (up to 30 kg); * Presence of nasal symptoms score greater than or equal to 5 (scale 0 to 12)in the last week; * Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.
Exclusion criteria
* Participation in clinical trial in 30 days prior to study entry; * Patients receiving immunotherapy; * Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ; * Patients with any clinically significant disease other than allergic rhinitis, including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders; * Patients on treatment with monoamine oxidase inhibitors (MAOIs); * Patients who were in use of oral antihistamines or decongestants in the past 15 days; * Patients who were treated with systemic corticosteroids in the last month; * Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score | 7 days | The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety will be evaluated by the adverse events occurrences | 7 days | Adverse events will be collected and followed in order to evaluate safety and tolerability |
Outcome results
None listed