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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01372865
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : September 18, 2017
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

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

Condition or disease Intervention/treatment Phase
Mild to Moderate Persistent Allergic Rhinitis Drug: Mometasone furoate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mometasone Drug: Mometasone furoate
Active Comparator: Nasonex® Drug: Mometasone furoate

Primary Outcome Measures :
  1. Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing [ Time Frame: 04 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01372865

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
Sao Paulo, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eurofarma Laboratorios S.A. Identifier: NCT01372865     History of Changes
Other Study ID Numbers: EF 119
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents