NCT02165826 - Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD | Biotech Hunter

Enrollment

1,323

Participants

Timeline

Start Date

May 1, 2014

Primary Completion Date

September 1, 2015

Study Completion Date

September 1, 2015

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Roflumilast

Roflumilast tablets

DRUG

Roflumilast Placebo

Roflumilast placebo-matching tablets

DRUG

Standard of Care COPD Treatment

The participant is on standard of care COPD maintenance treatment including LABAs, long-acting anticholinergics, or any combination thereof taken on a constant daily dose within 12 weeks prior to Screening (Visit V0) Examples of LABA containing products are: Formoterol, Salmeterol, Indacaterol, Formoterol/Budesonide, Salmeterol/Fluticasone, Treatment including lon-acting anticholinergics: Tiotropium, Aclidinium.

Trial Locations (2)

Unknown

Bardejov

Spišská Nová Ves