A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

Summary

Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD.

Timeline

Start

2015-12-23

Primary completion

2017-01-26

Completion

2017-01-26

Outcome

Met primary endpoint

registry analysis (superiority test); GFF MDI 14.4/9.6 µg vs Placebo MDI; p <0.0001; LS Mean ratio between treatments 1.75 NCT02643082 ↗

registry PRIMARY OUTCOME 2: Specific Airway Resistance (siRaw) [time frame: Day 15] NCT02643082 ↗

registry analysis (superiority test); GFF MDI 14.4/9.6 µg vs Placebo MDI; p <0.0001; LS Mean ratio between treatments 0.29 NCT02643082 ↗

paper GFF MDI treatment increased siVaw by 75% and reduced siRaw by 71% vs placebo MDI (both P<0.0001). PMID 30214185 ↗

Publications

• De Backer W, De Backer J, Vos W, Verlinden I, Van Holsbeke C, Clukers J, Hajian B, Siddiqui S, Jenkins M, Reisner C, Martin UJ. A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Aug 30;13:2673-2684. doi: 10.2147/COPD.S171707. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Formoterol	Other / unclassified	9.6 ug	Inhaled
Subject	Glycopyrronium	Unknown	14.4 ug	Inhaled

Indications