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

NCT ID: NCT01372865

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

Brief Summary

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

Detailed Description

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Conditions

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Mild to Moderate Persistent Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mometasone

Group Type EXPERIMENTAL

Mometasone furoate

Intervention Type DRUG

Nasonex®

Group Type ACTIVE_COMPARATOR

Mometasone furoate

Intervention Type DRUG

Interventions

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Mometasone furoate

Intervention Type DRUG

Mometasone furoate

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 26968623 (View on PubMed)

Other Identifiers

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EF 119

Identifier Type: -

Identifier Source: org_study_id