A Clinical Trial About Treatment of Mild to Moderate Persistent Alergic Rhinnitis With Test or Reference Mometasone (PUMA)

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective will be to compare the impact of the study formulations on alergic rhinitis carriers.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Mometasone Furoate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;