A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients

June 17, 2015 updated by: Eurofarma Laboratorios S.A.

A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients

The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sign the ICF
  • Age ≥ 12 years
  • Persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the ACQ-745 test (see Appendix C) ≤ 3.0
  • Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
  • Initial FEV1 of at least 40% of the predicted normal value
  • Serum cortisol assessment within normal values.

Exclusion Criteria:

  • Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
  • Requirement of admission due to asthma within the 3 months prior to study beginning
  • Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
  • Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
  • Recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
  • Intolerance or allergy to any of the components of the drugs assessed in the study
  • Pregnancy or lactation
  • Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Formoterol/Fluticasone Eurofarma
formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks
Drug: Formoterol/Fluticasone
Active Comparator: Foraseq®
formoterol + budedonide (12/400 mcg) twice a day per 12 weeks
Drug: Foraseq®
Active Comparator: Fluticasone
fluticasone (500 mcg) twice a day per 12 weeks
Drug: Fluticasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume in 1 second (FEV1) at final visit.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak expiratory flow (PEF)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF 065
  • CAINAS FF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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