NCT01529229CompletedPhase 3
A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Moderate - Severe Persistent Allergic Rhinitis
EMS0 sites210 target enrollmentStarted: November 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 210
- Primary Endpoint
- Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 11 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Desloratadine + Prednisolone
Experimental
Desloratadine(0.5 mg/ml) Associated With Prednisolone (4 mg/ml) Oral Solution once a day - bottle 1 + placebo 2 times a day - bottles 2 and 3.
Intervention: Desloratadine + Prednisolone (Drug)
Dexchlorpheniramine + Betamethasone
Active Comparator
Dexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3.
Intervention: Dexchlorpheniramine + Betamethasone (Drug)
Outcomes
Primary Outcomes
Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
Time Frame: 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 Outcomes
- Safety will be evaluated by the adverse events occurrences(7 days)
Investigators
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