A Clinical Trial About Treatment of Mild to Moderate Persistent Alergic Rhinnitis With Test or Reference Mometasone (PUMA)
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A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis With Eurofarma Mometasone or Reference Mometasone.
Actual Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Sign and date the informed consent form or, in case of subjects younger than 18 years, the document must also be signed by a legal guardian;
≥ 12 years old;
Suffer from mild to moderated persistent alergic rhinitis;
Total NIS scale score ≥ 4 points at the screening visit and within at least 4 of the 7 days before the randomization visit;
Indication for use nasal corticosteroid;
Present with alergic rhinitis symptoms for at least 2 years;
May undergo a washout period of at least 2 weeks
Patients with severe alergic rhinitis;
Patients with severe co-morbidities (at the investigator's criteria);
Patients with mild 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;
For female subjects, be pregnant or breastfeeding or planning to become pregnant or unwilling to use safe birth control methods during the study;
subjects in need of other drugs to treat alergic rhinitis, such as anti-immunoglobulin E, immunotherapy, anti-leukotrienes, oral corticosteroids, inhalant corticosteroids, or any administration route other than cutaneous;
Active smokers (use of cigarette, pipe, cigar or any other form of tobacco in any amount within the past 3 months before the study entry);
Participation in another clinical study within the past 12 months;