Back to resultsNon-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis (NOEX)
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Noex
Budecort Aqua
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
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.
Sites / Locations
- IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Noex
Budecort Aqua
Arm Description
The patients shall use the NOEX drug only once a day (one application in each nostril) during the 12 weeks of treatment
The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.
Outcomes
Primary Outcome Measures
The primary objective of the study is to evaluate the efficiency of Noex
Secondary Outcome Measures
The secondary objectives and endpoints of the study are to evaluate the safety of Noex®, according to the frequency of the adverse events.
Full Information
NCT ID
NCT01022047
First Posted
November 30, 2009
Last Updated
July 24, 2015
Sponsor
Eurofarma Laboratorios S.A.
1. Study Identification
Unique Protocol Identification Number
NCT01022047
Brief Title
Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Noex
Arm Type
Experimental
Arm Description
The patients shall use the NOEX drug only once a day (one application in each nostril) during the 12 weeks of treatment
Arm Title
Budecort Aqua
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Noex
Intervention Description
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
Intervention Name(s)
Budecort Aqua
Intervention Description
The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.
Primary Outcome Measure Information:
Title
The primary objective of the study is to evaluate the efficiency of Noex
Time Frame
5 months
Secondary Outcome Measure Information:
Title
The secondary objectives and endpoints of the study are to evaluate the safety of Noex®, according to the frequency of the adverse events.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Morato, M.D.
Organizational Affiliation
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis
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