Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD

Summary

A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Timeline

Start

2015-03-30

Primary completion

2017-08-31

Completion

2017-08-31

Outcome

Met primary endpoint

paper Treatment with GFF MDI improved the primary endpoint compared to GP MDI, FF MDI, and placebo MDI PMID 32021143 ↗

paper At week 24, GFF MDI improved morning pre-dose trough FEV1 versus GP MDI PMID 32450869 ↗

Publications

• Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
• Martinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y.
• Martinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020.
• Chen R, Zhong N, Wang HY, Zhao L, Mei X, Qin Z, Huang J, Assam PN, Maes A, Siddiqui S, Martin UJ, Reisner C. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 8;15:43-56. doi: 10.2147/COPD.S223638. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Formoterol	Other / unclassified	9.6 ug	Inhaled
Subject	Glycopyrronium	Unknown	18 ug	Inhaled

Indications