Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for 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:
NCT01529229
First received: February 6, 2012
Last updated: September 24, 2013
Last verified: September 2013

February 6, 2012
September 24, 2013
October 2013
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01529229 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment
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

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.

  • 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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Rhinitis
  • 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
  • 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
  • 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.
    Intervention: Drug: Desloratadine + Prednisolone
  • Active Comparator: Dexchlorpheniramine + Betamethasone
    Dexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3.
    Intervention: Drug: Dexchlorpheniramine + Betamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
210
September 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
2 Years to 11 Years
No
Contact: Felipe Pinho, MD +551938879359 felipe.pinho@ems.com.br
Not Provided
 
NCT01529229
DPREMS1111
Yes
EMS
EMS
Not Provided
Principal Investigator: Dirceu Solé, MD Federal University of São Paulo
EMS
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP