Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment

EMS

Status and phase: Unknown; Phase 3

Conditions: Allergic Rhinitis

Treatments: Drug: Dexchlorpheniramine + Betamethasone; Drug: Desloratadine + Prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01720485

DPCEMS0812

Details and patient eligibility

About

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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 2 patient groups

Desloratadine + Prednisolone

Experimental group

Description:

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.

Treatment:

Drug: Desloratadine + Prednisolone

Dexchlorpheniramine + Betamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Dexchlorpheniramine + Betamethasone