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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Salmeterol/Fluticasone; Drug: Seretide

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
• Enrollment (Actual): 334
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Curitiba, PR, Brazil
    • Hospital de Clinicas UFPR
  • Salvador, BA, Brazil
    • Centro de Referencia em Enfermidades Respiratoria e Alergica
  • Sorocaba, SP, Brazil
    • Clinica de Alergia Martti Antila
  • São Paulo, Brazil
    • IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
  • São Paulo, Brazil
    • Centro de Estudos de Pneumologia FMABC
  • São Paulo, Brazil
    • Stelmach Pesquisa Clinica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Seretide	Drug: Seretide
Experimental: Salmeterol/Fluticasone	Drug: Salmeterol/Fluticasone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Expiratory Flow Peak (EFP)

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimated): September 15, 2010

Study Record Updates

• Last Update Posted (Actual): March 31, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Sympathomimetics; Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: EF113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No