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

Mild to Moderate Persistent Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372865
• Other study ID #: EF 119
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2011
• Last updated: September 15, 2017
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2017
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Mild to Moderate Persistent Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Mometasone furoate

• Mometasone furoate

Locations

Country	Name	City	State
Brazil	IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

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