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A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients With Asthma (CAINAS SF)

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ClinicalTrials.gov Identifier: NCT01202097
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : May 8, 2012
Sponsor:
Information provided by:
Eurofarma Laboratorios S.A.

Brief Summary:
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.

Condition or disease Intervention/treatment Phase
Asthma Drug: Salmeterol/Fluticasone Drug: Seretide Phase 3

Detailed Description:

The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.

Primary endpoint: Forced expiratory volume in 1 second (FEV1) at the final visit.

Secondary endpoints: Expiratory Flow Peak (EFP), symptoms score, FEV1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE III, RANDOMIZED, OPEN-LABEL, NON-INFERIORITY COMPARATIVE STUDY BETWEEN SERETIDE® 50/250 µG AND SALMETEROL/FLUTICASONE SINGLE INHALATION CAPSULE 50/250 µG EUROFARMA IN PATIENTS WITH ASTHMA
Study Start Date : August 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Salmeterol/Fluticasone Drug: Salmeterol/Fluticasone
Active Comparator: Seretide Drug: Seretide



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

Secondary Outcome Measures :
  1. Expiratory Flow Peak (EFP)


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

Inclusion Criteria:

  • Sign the ICF
  • ≥ 12 years old
  • Have a persistent asthma diagnosis, as per GINA classification,18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test (please see Appendix C) ≤ 3.0
  • Current use of inhaled corticosteroid (up to 1000 µg of beclomethasone dipropionate) whether combined or not with long-term β2-adrenergics and relief medication (salbutamol or equivalent)
  • Initial FEV1 of at least 40% of the normal value expected
  • Blood cortisol evaluation within the normal limits.

Exclusion Criteria:

  • Use of oral or parenteral corticosteroid within the last 3 previous months to the study
  • Hospitalization needed due to asthma within the last 3 previous months to the study
  • Active smokers, defined as the consumption of cigarettes, pipes, cigars or any other form of smoking in any amount within the last 3 months
  • Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
  • Recent (<6 months) or expected participation during this study in other clinical trials involving drugs of any nature or in studies consisting of any - Intolerance or allergy to any component of the drugs evaluated in the study
  • Pregnant or lactating women
  • Chronic use of routine β-blockers, orally or intravenously, including 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 ClinicalTrials.gov identifier (NCT number): NCT01202097


Locations
Brazil
Hospital de Clinicas UFPR
Curitiba, PR, Brazil
Centro de Referencia em Enfermidades Respiratoria e Alergica
Salvador, BA, Brazil
Clinica de Alergia Martti Antila
Sorocaba, SP, Brazil
Centro de Estudos de Pneumologia FMABC
São Paulo, Brazil
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, Brazil
Stelmach Pesquisa Clinica
São Paulo, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.

Responsible Party: Máyra Gimenez Solá Zambrana, Eurofarma Laboratorios Ltda
ClinicalTrials.gov Identifier: NCT01202097     History of Changes
Other Study ID Numbers: EF113
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: September 2010

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists