A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients

Asthma Clinical Trial

Official title:

A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202084
• Other study ID #: EF 065
• Secondary ID: CAINAS FF
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2010
• Last updated: June 17, 2015
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: May 2012
• 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 impact of the study formulations on pulmonary function in persistent asthma carriers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Sign the ICF

• Age = 12 years

• Persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the ACQ-745 test (see Appendix C) = 3.0

• Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term ß2-adrenergic agents and breakthrough medication (salbutamol or equivalent)

• Initial FEV1 of at least 40% of the predicted normal value

• Serum cortisol assessment within normal values.

Exclusion Criteria:

• Use of oral or parenteral corticosteroid within the 3 months prior to study beginning

• Requirement of admission due to asthma within the 3 months prior to study beginning

• Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months

• Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma

• Recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma

• Intolerance or allergy to any of the components of the drugs assessed in the study

• Pregnancy or lactation

• Chronic use of ß-blocker medications, per routine oral or intravenous route, or also as 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:
• Formoterol/Fluticasone

• Foraseq®

• Fluticasone

Locations

Country	Name	City	State
Brazil	IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada	São Paulo

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 final visit.		12 weeks	No
Secondary	Peak expiratory flow (PEF)		12 weeks	No