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

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ClinicalTrials.gov Identifier: NCT01529229
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
EMS

Tracking Information
First Submitted Date  ICMJE February 6, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date January 15, 2015
Study Start Date  ICMJE November 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score [ Time Frame: 7 days ]
The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01529229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Safety will be evaluated by the adverse events occurrences [ Time Frame: 7 days ]
Adverse events will be collected and followed in order to evaluate safety and tolerability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2012)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529229
Other Study ID Numbers  ICMJE DPREMS1111
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMS
Study Sponsor  ICMJE EMS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dirceu Solé, MD Federal University of São Paulo
PRS Account EMS
Verification Date January 2015

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