Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD
Status:
Withdrawn
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
A study multicenter, phase III, randomized, open label study to evaluate the efficacy and
safety of a fixed-dose combination of formoterol/fluticasone and salmeterol/fluticasone in
patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) that will
enroll 336 subjects aged ≥ 40 years, smokers or former smokers, diagnosed with chronic
obstructive pulmonary disease, classified as moderate chronic obstructive pulmonary disease
or severe according to GOLD spirometric classification. The subjects will be allocated in 2
parallel groups and will receive the medicines of study, according of the randomization
during a 24-week.
Phase:
Phase 3
Details
Lead Sponsor:
Ache Laboratorios Farmaceuticos S.A.
Treatments:
Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Fluticasone-Salmeterol Drug Combination Formoterol Fumarate Salmeterol Xinafoate Xhance