A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults With Moderate - Severe Persistent Allergic Rhinitis
Overview
- Phase
- Phase 3
- Intervention
- Desloratadine + Prednisolone
- Conditions
- Allergic Rhinitis
- Sponsor
- EMS
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
- Last Updated
- 12 years ago
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 in Adults.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Consent of the patient;
- •Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
- •Adults aged ≥ 18 years old;
- •Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.
Exclusion Criteria
- •Decongestants dependent patients or patients receiving allergen specific immunotherapy;
- •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 on treatment with monoamine oxidase inhibitors (MAOIs);
- •Patients with history of hypersensitivity to any of the formula compounds;
- •Patients with any clinically significant disease that in the investigator opinion can not participate in the study
- •Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.
- •Participation in clinical trial in 30 days prior to study entry;
Arms & Interventions
Desloratadine + Prednisolone
The patients will take 2 tablets three times a day, as follows: Morning: 1 tablet of the test medication(Desloratadine 5 mg + Prednisolone 20 mg) + 1 tablet of placebo control medication. Afternoon: 1 tablet of placebo test medication + 1 tablet of placebo control medication. Night: 1 tablet of placebo test medication + 1 tablet of placebo control medication.
Intervention: Desloratadine + Prednisolone
Dexchlorpheniramine + Betamethasone
The patients will take 2 tablets three times a day, as follows: Morning: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. Afternoon: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. Night: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
Intervention: Dexchlorpheniramine + Betamethasone
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)