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

Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Rhinitis

Intervention: Desloratadine + Prednisolone (Drug); Dexchlorpheniramine + Betamethasone (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: EMS


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score

Secondary outcome: Safety will be evaluated by the adverse events occurrences


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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;

Locations and Contacts

IMA - Instituto de Pesquisa Clínica e Medicina Avançada, São Paulo, Brazil; Not yet recruiting
Fabio M Castro, MD, Phone: 55 11 38639156, Email: daniela.fakih@imabrasil.com
Fabio M Castro, MD, Principal Investigator
Additional Information

Starting date: October 2013
Last updated: September 24, 2013

Page last updated: August 23, 2015

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