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

Condition(s) targeted: Mild to Moderate Persistent Allergic Rhinitis

Intervention: Mometasone furoate (Drug); Mometasone furoate (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Eurofarma Laboratorios S.A.

Overall contact:
Fabio Castro, Phone: 55 11 38639156

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

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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;

Fabio Castro, Phone: 55 11 38639156

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada, Sao Paulo, Brazil; Not yet recruiting
Fabio Castro, Phone: 55 11 38639156
Fabio Castro, Principal Investigator

Starting date: December 2011
Last updated: June 13, 2011