Phase
Condition
Allergy (Pediatric)
Acute Rhinitis
Allergy
Treatment
N/AClinical Study ID
Ages > 12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign the informed consent form or - in case of patients younger than 18 years, thelegal 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 (seeAppendix 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 orinhalant corticosteroid agent; see 6.4).
Exclusion
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 nasalseptum deviation, nasal polyps or any other type of nasal malformation;
Pregnant women and patients planning to become pregnant during the study period orbreastfeeding women;
Patients in need of other drugs to treat the allergic rhinitis, such asanti-immunoglobulin E, allergen-specific immunotherapy, anti-leukotrienes, systemicvasoconstrictors, oral corticosteroids and other inhalant corticosteroids. Patients using allergen-specific immunotherapy during the last year, as well as usinganti-leukotrienes and anti-immunoglobulin E during the last month, or even patients usinginhalant or oral corticosteroids after V0 will not be enrolled in the study.
Study Design
Study Description
Connect with a study center
IMA Brasil - Instituto de Pesquisa ClÃnica e Medicina Avançada
São Paulo,
BrazilSite Not Available
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo,
BrazilSite Not Available
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