A 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

NCT01911364 Phase 3 COMPLETED

The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)

Details

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 3
Status	COMPLETED
Enrolment	3686
Start date	2014-01
Completion	2016-03

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• BDP/FF/GB
• Tiotropium
• BDP/FF + Tiotropium

Primary outcomes

• COPD exacerbation rate — 52 weeks
  Moderate and severe COPD exacerbation rate over 52 weeks of treatment.

Countries

Germany, Hungary, Italy