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

Eurofarma

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Salmeterol/Fluticasone

Drug: Seretide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01202097

EF113

Details and patient eligibility

About

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.

Full description

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.

Enrollment

334 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.