Back to resultsComparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment
Primary Purpose
Allergic Rhinitis
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Desloratadine + Prednisolone
Dexchlorpheniramine + Betamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility 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;
Sites / Locations
- IMA - Instituto de Pesquisa Clínica e Medicina Avançada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desloratadine + Prednisolone
Dexchlorpheniramine + Betamethasone
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01720485
Brief Title
Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desloratadine + Prednisolone
Arm Type
Experimental
Arm 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.
Arm Title
Dexchlorpheniramine + Betamethasone
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Desloratadine + Prednisolone
Intervention Description
1 tablet 3 times a day
Intervention Type
Drug
Intervention Name(s)
Dexchlorpheniramine + Betamethasone
Intervention Description
1 tablet 3 times a day
Primary Outcome Measure Information:
Title
Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
Description
The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Description
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Facility Information:
Facility Name
IMA - Instituto de Pesquisa Clínica e Medicina Avançada
City
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio M Castro, MD
Phone
55 11 38639156
Email
daniela.fakih@imabrasil.com
First Name & Middle Initial & Last Name & Degree
Fabio M Castro, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment
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