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

NCT01202097 | Completed Phase 3 DMC

• 1 other identifier: EF113
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 6

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Expiratory Flow Peak (EFP)

Study Arms (2)

Salmeterol/Fluticasone

EXPERIMENTAL

Drug: Salmeterol/Fluticasone

Seretide

ACTIVE COMPARATOR

Drug: Seretide

Interventions

Salmeterol/Fluticasone DRUG

Salmeterol/Fluticasone

Seretide DRUG

Seretide

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (6)

Hospital de Clinicas UFPR

Curitiba, PR, Brazil

Location

Centro de Referencia em Enfermidades Respiratoria e Alergica

Salvador, BA, Brazil

Location

Centro de Estudos de Pneumologia FMABC

São Paulo, Brazil

Location

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, Brazil

Location

Stelmach Pesquisa Clinica

São Paulo, Brazil

Location

Clinica de Alergia Martti Antila

Sorocaba, SP, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 15, 2010
• Study Start: August 1, 2011
• Study Completion: May 1, 2012
• Last Updated: March 31, 2025

Record last verified: 2010-09

Locations

BR (6)