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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Sign the informed consent form or - in case of patients younger than 18 years, the legal 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 (see Appendix 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 or inhalant corticosteroid agent; see 6.4).

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 nasal septum deviation, nasal polyps or any other type of nasal malformation;

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

• Patients in need of other drugs to treat the allergic rhinitis, such as anti-immunoglobulin E, allergen-specific immunotherapy, anti-leukotrienes, systemic vasoconstrictors, oral corticosteroids and other inhalant corticosteroids.

Patients using allergen-specific immunotherapy during the last year, as well as using anti-leukotrienes and anti-immunoglobulin E during the last month, or even patients using inhalant or oral corticosteroids after V0 will not be enrolled in the study.