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

Allergic Rhinitis Clinical Trial

— NOEX  

Official title:

A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis in a Test Group Treated With Noex 32 mcg and a Reference Group Treated With Budecort Aqua® 32 mcg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022047
• Other study ID #: EF096
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2009
• Last updated: July 24, 2015
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Noex
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.

Locations

Country	Name	City	State
Brazil	IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of the study is to evaluate the efficiency of Noex		5 months	No
Secondary	The secondary objectives and endpoints of the study are to evaluate the safety of Noex®, according to the frequency of the adverse events.		5 months	Yes