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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Salmeterol/Fluticasone
Seretide
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clinicas UFPR
  • Centro de Referencia em Enfermidades Respiratoria e Alergica
  • Clinica de Alergia Martti Antila
  • Centro de Estudos de Pneumologia FMABC
  • IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
  • Stelmach Pesquisa Clinica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Salmeterol/Fluticasone

Seretide

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Expiratory Flow Peak (EFP)

Full Information

First Posted
September 14, 2010
Last Updated
May 4, 2012
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01202097
Brief Title
A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients With Asthma
Acronym
CAINAS SF
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Salmeterol/Fluticasone
Arm Type
Experimental
Arm Title
Seretide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Salmeterol/Fluticasone
Intervention Type
Drug
Intervention Name(s)
Seretide
Primary Outcome Measure Information:
Title
Forced expiratory volume in 1 second (FEV1) at the final visit.
Secondary Outcome Measure Information:
Title
Expiratory Flow Peak (EFP)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital de Clinicas UFPR
City
Curitiba, PR
Country
Brazil
Facility Name
Centro de Referencia em Enfermidades Respiratoria e Alergica
City
Salvador, BA
Country
Brazil
Facility Name
Clinica de Alergia Martti Antila
City
Sorocaba, SP
Country
Brazil
Facility Name
Centro de Estudos de Pneumologia FMABC
City
São Paulo
Country
Brazil
Facility Name
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
City
São Paulo
Country
Brazil
Facility Name
Stelmach Pesquisa Clinica
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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