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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01202084
First received: September 14, 2010
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Formoterol/Fluticasone
Drug: Foraseq®
Drug: Fluticasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Forced expiratory volume in 1 second (FEV1) at final visit.

Secondary Outcome Measures:
  • Peak expiratory flow (PEF)

Estimated Enrollment: 222
Study Start Date: January 2012
Estimated Study Completion Date: November 2012
Arms Assigned Interventions
Experimental: Formoterol/Fluticasone Eurofarma Drug: Formoterol/Fluticasone
Active Comparator: Foraseq® Drug: Foraseq®
Active Comparator: Fluticasone Drug: Fluticasone

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202084

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

No publications provided

Responsible Party: Máyra Gimenez Solá Zambrana, Eurofarma Laboratórios Ltda
ClinicalTrials.gov Identifier: NCT01202084     History of Changes
Other Study ID Numbers: EF 065, CAINAS FF
Study First Received: September 14, 2010
Last Updated: May 4, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014