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

Eurofarma

Status and phase

Completed

Phase 3

Conditions

Allergic Rhinitis

Treatments

Drug: Budecort Aqua

Drug: Noex

Study type

Interventional

Funder types

Industry

Identifiers

NCT01022047

EF096

Details and patient eligibility

About

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.

Full 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;

Enrollment

280 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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.