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

Phase 3

Completed

• Conditions: Mild to Moderate Persistent Allergic Rhinitis
• Interventions: Drug: Mometasone furoate

• Registration Number: NCT01372865
• Lead Sponsor: Eurofarma Laboratorios S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Study Start: 2012-06
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mometasone	Mometasone furoate	-
Nasonex®	Mometasone furoate	-

Primary Outcome Measures

Name	Time	Method
Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing	04 weeks

Trial Locations

Locations (1)

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada; 🇧🇷 Sao Paulo, Brazil