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