Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis

Last updated: July 24, 2015
Sponsor: Eurofarma Laboratorios S.A.
Overall Status: Completed

Phase

3

Condition

Allergy (Pediatric)

Acute Rhinitis

Allergy

Treatment

N/A

Clinical Study ID

NCT01022047
EF096
  • Ages > 12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sign the informed consent form or - in case of patients younger than 18 years, thelegal responsible must sign the consent;

  • ≥ 12 years old;

  • NIS scale score > 4 points at the randomization visit

  • Patients with persistent mild to moderate AR, according to the ARIA criteria (seeAppendix B), with indication for use budesonide;

  • Positive skin test for at least one relevant airborne agent;

  • AR symptoms for at least 2 years;

  • May undergo a washout period of at least 2 weeks (without using any oral, nasal orinhalant corticosteroid agent; see 6.4).

Exclusion

Exclusion Criteria:

  • Patients with persistent severe allergic rhinitis;

  • Patients with severe co-morbidities (at the investigator's opinion);

  • Patients with moderate to severe persistent asthma;

  • Clinical history of infection of the airways 30 days before the study entry;

  • Patients with structural changes causing nasal obstruction, such as pronounced nasalseptum deviation, nasal polyps or any other type of nasal malformation;

  • Pregnant women and patients planning to become pregnant during the study period orbreastfeeding women;

  • Patients in need of other drugs to treat the allergic rhinitis, such asanti-immunoglobulin E, allergen-specific immunotherapy, anti-leukotrienes, systemicvasoconstrictors, oral corticosteroids and other inhalant corticosteroids. Patients using allergen-specific immunotherapy during the last year, as well as usinganti-leukotrienes and anti-immunoglobulin E during the last month, or even patients usinginhalant or oral corticosteroids after V0 will not be enrolled in the study.

Study Design

Total Participants: 280
Study Start date:
February 01, 2010
Estimated Completion Date:
December 31, 2010

Study Description

Primary objective: To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.

Secondary objectives: To determine the total NIS scale score after 12 weeks of treatment and the scores of the same scale individually for the symptoms of nasal obstruction, coryza, sneezing and nasal pruritus after 4 and 12 weeks of treatment, as well as to assess the safety of the study product according to the presence of adverse events.

Some eligibility criteria:

  • NIS scale score > 4 points at the randomization visit

  • Patients with persistent mild to moderate AR, according to the ARIA criteria with indication for use budesonide;

Connect with a study center

  • IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

    São Paulo,
    Brazil

    Site Not Available

  • IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

    São Paulo,
    Brazil

    Site Not Available

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