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OpenTrials
Completed

NCT Number: NCT01372865

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

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

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Mometasone furoate

Drug

Primary outcomes

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

    Time frame: 04 weeks

Sponsors and collaborators

Lead sponsor

Eurofarma Laboratorios S.A.

Industry

Registry information

Official study title

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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 14, 2011
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.