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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Eurofarma Laboratorios S.A..
Recruitment status was  Active, not recruiting
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
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: 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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 14, 2014