Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment

This study has been completed.
Information provided by (Responsible Party):
EMS Identifier:
First received: February 6, 2012
Last updated: January 14, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Allergic Rhinitis
Drug: Dexchlorpheniramine + Betamethasone
Drug: Desloratadine + Prednisolone
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, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) 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: No ]
    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

Enrollment: 210
Study Start Date: November 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desloratadine + Prednisolone
Desloratadine(0.5 mg/ml) Associated With Prednisolone (4 mg/ml) Oral Solution once a day - bottle 1 + placebo 2 times a day - bottles 2 and 3.
Drug: Desloratadine + Prednisolone
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Active Comparator: Dexchlorpheniramine + Betamethasone
Dexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3.
Drug: Dexchlorpheniramine + Betamethasone
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Detailed Description:
  • double-blind, non-inferiority, prospective, parallel group trial.
  • Experiment duration: 07 days.
  • 02 visits (days 0 and 7).
  • Efficacy will be evaluated for persistent allergic rhinitis based on nasal symptoms score
  • Adverse events evaluation.

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Consent of the patient or legal guardian;
  • Clinical diagnosis of moderate - severe persistent allergic rhinitis according to the classification of ARIA (Allergic Rhinitis and Its Impact on Asthma);
  • Children aged between 2 and 11 years and 11 months (up to 30 kg);
  • Presence of nasal symptoms score greater than or equal to 5 (scale 0 to 12)in the last week;
  • Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.

Exclusion Criteria:

  • Participation in clinical trial in 30 days prior to study entry;
  • Patients receiving immunotherapy;
  • Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
  • Patients with any clinically significant disease other than allergic rhinitis, including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
  • Patients on treatment with monoamine oxidase inhibitors (MAOIs);
  • 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 who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01529229

Sponsors and Collaborators
Principal Investigator: Dirceu Solé, MD Federal University of São Paulo
  More Information

Responsible Party: EMS Identifier: NCT01529229     History of Changes
Other Study ID Numbers: DPREMS1111 
Study First Received: February 6, 2012
Last Updated: January 14, 2015
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Rhinitis, Allergic
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antineoplastic Agents processed this record on May 26, 2016