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

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.

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

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Persistent Allergic Rhinitis
• Intervention / Treatment: Drug: Mometasone furoate

• Study Type: Interventional
• Enrollment (Actual): 364
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mometasone	Drug: Mometasone furoate
ACTIVE_COMPARATOR: Nasonex®	Drug: Mometasone furoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing	04 weeks

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Publications and helpful links

General Publications

• Antila MA, Castro FM, Sano F, Machado A, Fernandes F, Rosario Filho NA, Stelmach R. Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA). Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):580-8. doi: 10.1016/j.bjorl.2015.11.009. Epub 2016 Feb 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (ESTIMATE): June 14, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: EF 119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No