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

Summary

The purpose of this study is to evaluate discontinuation rates of roflumilast using an up-titration regimen for the first 4 weeks of treatment compared with continuous treatment of 500 μg one daily (OD) during the entire 12-week main period, and to evaluate if participants who do not tolerate roflumilast 500 μg OD have a drug exposure with 250 μg roflumilast OD similar to that observed in other participants with the 500 μg OD dose.

Timeline

Start

2014-05-01

Primary completion

2015-09-01

Completion

2015-09-01

Outcome

Mixed primary results

registry Roflumilast 250 μg OD Then 500 μg OD vs Roflumilast 500 μg OD; p = 0.017; Odds Ratio (OR) 0.66 (95% CI 0.47 to 0.93) NCT02165826 ↗

registry Roflumilast 500 μg EOD Then 500 μg OD vs Roflumilast 500 μg OD; p = 0.114; Odds Ratio (OR) 0.76 (95% CI 0.55 to 1.07) NCT02165826 ↗

Publications

• Facius A, Marostica E, Gardiner P, Watz H, Lahu G. Pharmacokinetic and Pharmacodynamic Modelling to Characterize the Tolerability of Alternative Up-Titration Regimens of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2018 Aug;57(8):1029-1038. doi: 10.1007/s40262-018-0671-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roflumilast	Small molecule	250 ug	Oral
Subject	Roflumilast	Small molecule	500 ug	Oral
Background	Aclidinium	Unknown	—	—
Background	Formoterol	Other / unclassified	—	—
Background	Formoterol/Budesonide	Unknown	—	—
Background	Indacaterol	Other / unclassified	—	—
Background	Salmeterol	Other / unclassified	—	—
Background	Salmeterol/Fluticasone	Unknown	—	—
Background	Tiotropium	Other / unclassified	—	—

Indications