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

Eurofarma

Status and phase

Completed

Phase 3

Conditions

Mild to Moderate Persistent Allergic Rhinitis

Treatments

Drug: Mometasone furoate

Study type

Interventional

Funder types

Industry

Identifiers

EF 119

Details and patient eligibility

About

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

Enrollment

364 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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;