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

NCT01022047 | Completed Phase 3 DMC

• 1 other identifier: EF096
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is to evaluate the efficiency of Noex

  5 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Noex

EXPERIMENTAL

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

Drug: Noex

Budecort Aqua

ACTIVE COMPARATOR

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

Drug: Budecort Aqua

Interventions

Noex DRUG

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

Noex

Budecort Aqua DRUG

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

Budecort Aqua

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, Brazil

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Fabio Morato, M.D.

  IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 1, 2009
• Study Start: February 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 27, 2015

Record last verified: 2010-12

Locations

BR (1)