Overview

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

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eurofarma Laboratorios S.A.
Treatments:
Fluticasone
Formoterol Fumarate
Xhance
Criteria
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