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).

NCT01393145 Phase 3 WITHDRAWN

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.

Details

Lead sponsor	Ache Laboratorios Farmaceuticos S.A.
Phase	Phase 3
Status	WITHDRAWN
Start date	2011-08
Completion	2012-08

Conditions

• Chronic Obstructive Pulmonary Disease
• COPD

Interventions

• Combination Fluticasone /Formoterol 12/250 μg
• Seretide Diskus (salmeterol/fluticasone) 50/250 μg

Primary outcomes

• Changes in pre-bronchodilator forced expiratory volume in first second (FEV1) — Comparative between baseline and week 24
  Changes of lung function parameter