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

Sponsor:	Eurofarma Laboratorios S.A.
Information provided by:	Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:	NCT01022047

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Noex Drug: Budecort Aqua	Phase III

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

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:

The primary objective of the study is to evaluate the efficiency of Noex [ Time Frame: 5 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	February 2010
Study Completion Date:	December 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Noex The patients shall use the NOEX drug only once a day (one application in each nostril) during the 12 weeks of treatment	Drug: Noex The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment
Active Comparator: 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.	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.

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;

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022047

Locations

Brazil
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, Brazil

Sponsors and Collaborators

Eurofarma Laboratorios S.A.

Investigators

Principal Investigator:

Fabio Morato, M.D.

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

More Information

No publications provided

Responsible Party:	Fernanda Scalzaretto Martinez, Eurofarma Laboratórios Ltda
ClinicalTrials.gov Identifier:	NCT01022047 History of Changes
Other Study ID Numbers:	EF096
Study First Received:	November 30, 2009
Last Updated:	May 4, 2011
Health Authority:	Brazil: Ethics Committee; Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012