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OpenTrials
Completed

NCT Number: NCT01529229

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

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexchlorpheniramine + Betamethasone

Drug

Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Desloratadine + Prednisolone

Drug

Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2012
Registry last updated
Jan 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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