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

NCT ID: NCT01022047

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-12-31

Brief 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.

Detailed 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;

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Noex

The patients shall use the NOEX drug only once a day (one application in each nostril) during the 12 weeks of treatment

Group Type: EXPERIMENTAL

Noex

Intervention Type: DRUG

The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment

Budecort Aqua

The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.

Group Type: ACTIVE_COMPARATOR

Budecort Aqua

Intervention Type: DRUG

The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.

Interventions

Noex

The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment

Intervention Type: DRUG

Budecort Aqua

The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabio Morato, M.D.

Role: PRINCIPAL_INVESTIGATOR

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

Locations

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

EF096

Identifier Type: -

Identifier Source: org_study_id