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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01372865

Enrollment

364

Registered

2011-06-14

Start date

2012-06-30

Completion date

2013-03-31

Last updated

2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Persistent Allergic Rhinitis

Brief summary

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

Interventions

DRUGMometasone furoate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026