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

NCT ID: NCT01720485

Last Updated: 2013-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Desloratadine + Prednisolone

Intervention Type DRUG

1 tablet 3 times a day

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.

Group Type ACTIVE_COMPARATOR

Dexchlorpheniramine + Betamethasone

Intervention Type DRUG

1 tablet 3 times a day

Interventions

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Desloratadine + Prednisolone

1 tablet 3 times a day

Intervention Type DRUG

Dexchlorpheniramine + Betamethasone

1 tablet 3 times a day

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IMA - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, , Brazil

Site Status

Countries

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Brazil

Facility Contacts

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Fabio M Castro, MD

Role: primary

Other Identifiers

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DPCEMS0812

Identifier Type: -

Identifier Source: org_study_id