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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01720485
First received: October 31, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Drug: Desloratadine + Prednisolone
Drug: Dexchlorpheniramine + Betamethasone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability


Estimated Enrollment: 234
Study Start Date: October 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Desloratadine + Prednisolone
1 tablet 3 times a day
Active Comparator: 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.

Drug: Dexchlorpheniramine + Betamethasone
1 tablet 3 times a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720485

Locations
Brazil
IMA - Instituto de Pesquisa Clínica e Medicina Avançada Not yet recruiting
São Paulo, Brazil
Contact: Fabio M Castro, MD    55 11 38639156    daniela.fakih@imabrasil.com   
Principal Investigator: Fabio M Castro, MD         
Sponsors and Collaborators
EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01720485     History of Changes
Other Study ID Numbers: DPCEMS0812
Study First Received: October 31, 2012
Last Updated: September 24, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Chlorpheniramine
Desloratadine
Dexchlorpheniramine
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 29, 2014