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

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ClinicalTrials.gov Identifier: NCT01022047
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Noex Drug: Budecort Aqua Phase 3

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;

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : February 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. The primary objective of the study is to evaluate the efficiency of Noex [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022047


Locations
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Brazil
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Investigators
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Principal Investigator: Fabio Morato, M.D. IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

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Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01022047     History of Changes
Other Study ID Numbers: EF096
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: December 2010

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists