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

Eurofarma

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Formoterol/Fluticasone; Drug: Fluticasone; Drug: Foraseq®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202084

EF 065

CAINAS FF

Details and patient eligibility

About

The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.

Enrollment: 222 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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 β2-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 β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 3 patient groups

Formoterol/Fluticasone Eurofarma

Experimental group

Description:

formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks

Treatment:

Drug: Formoterol/Fluticasone

Foraseq®

Active Comparator group

Description:

formoterol + budedonide (12/400 mcg) twice a day per 12 weeks

Treatment:

Drug: Foraseq®

Fluticasone

Active Comparator group

Description:

fluticasone (500 mcg) twice a day per 12 weeks

Treatment:

Drug: Fluticasone