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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01202084
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : June 18, 2015
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

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

Primary Outcome Measures :
  1. Forced expiratory volume in 1 second (FEV1) at final visit. [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01202084

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

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Responsible Party: Eurofarma Laboratorios S.A. Identifier: NCT01202084     History of Changes
Other Study ID Numbers: EF 065
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: May 2012

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