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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Eurofarma Laboratorios S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01372865
First received: June 13, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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


Condition Intervention Phase
Mild to Moderate Persistent Allergic Rhinitis
Drug: Mometasone furoate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing

Estimated Enrollment: 364
Study Start Date: December 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mometasone Drug: Mometasone furoate
Active Comparator: Nasonex® Drug: Mometasone furoate

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372865

Contacts
Contact: Fabio Castro 55 11 38639156

Locations
Brazil
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada Not yet recruiting
Sao Paulo, Brazil
Contact: Fabio Castro    55 11 38639156      
Principal Investigator: Fabio Castro         
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Fernanda Scalzareto Martinez, Eurofarma Laboratórios Ltda
ClinicalTrials.gov Identifier: NCT01372865     History of Changes
Other Study ID Numbers: EF 119
Study First Received: June 13, 2011
Last Updated: June 13, 2011
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on October 16, 2014