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

NCT01372865 | Completed Phase 3 DMC

• 1 other identifier: EF 119
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild to Moderate Persistent Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing

  04 weeks

Study Arms (2)

Mometasone

EXPERIMENTAL

Drug: Mometasone furoate

Nasonex®

ACTIVE COMPARATOR

Drug: Mometasone furoate

Interventions

Mometasone furoate DRUG

Mometasone

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26968623 DERIVED

MeSH Terms

Interventions

Mometasone Furoate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 14, 2011
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

BR (1)