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

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202097
• Other study ID #: EF113
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2010
• Last updated: May 4, 2012
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2010
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 ß2-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 ß-blockers, orally or intravenously, including ophthalmic solutions.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol/Fluticasone

• Seretide

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas UFPR	Curitiba, PR
Brazil	Centro de Referencia em Enfermidades Respiratoria e Alergica	Salvador, BA
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	Clinica de Alergia Martti Antila	Sorocaba, SP

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in 1 second (FEV1) at the final visit.
Secondary	Expiratory Flow Peak (EFP)