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

Last updated: September 15, 2017
Sponsor: Eurofarma Laboratorios S.A.
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT01372865
EF 119
  • Ages > 12
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 7days 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

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 nasalseptum deviation, nasal polyps or any other type of nasal malformation;

  • For female subjects, be pregnant or breastfeeding or planning to become pregnant orunwilling to use safe birth control methods during the study;

  • subjects in need of other drugs to treat alergic rhinitis, such as anti-immunoglobulinE, 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 anyamount within the past 3 months before the study entry);

  • Participation in another clinical study within the past 12 months;

Study Design

Total Participants: 364
Study Start date:
June 01, 2012
Estimated Completion Date:
March 31, 2013

Connect with a study center

  • IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

    Sao Paulo,
    Brazil

    Site Not Available

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