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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01720485
• Other study ID #: DPCEMS0812
• Status: Unknown status
• Phase: Phase 3
• First received: October 31, 2012
• Last updated: September 24, 2013
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2013
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 234
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Desloratadine + Prednisolone
1 tablet 3 times a day
• Dexchlorpheniramine + Betamethasone
1 tablet 3 times a day

Locations

Country	Name	City	State
Brazil	IMA - Instituto de Pesquisa Clínica e Medicina Avançada	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score	The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.	7 days
Secondary	Safety will be evaluated by the adverse events occurrences	Adverse events will be collected and followed in order to evaluate safety and tolerability	7 days