Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A. Identifier:
First received: September 14, 2010
Last updated: June 17, 2015
Last verified: May 2012
The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Peak expiratory flow (PEF) [ Time Frame: 12 weeks ]

Enrollment: 222
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sign the ICF
  • Age ≥ 12 years
  • Persistent asthma diagnosis, as per the GINA classification (,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 identifier: NCT01202084

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

Responsible Party: Eurofarma Laboratorios S.A. Identifier: NCT01202084     History of Changes
Other Study ID Numbers: EF 065
Study First Received: September 14, 2010
Last Updated: June 17, 2015

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
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 processed this record on April 24, 2017