PT  - JOURNAL ARTICLE
AU  - Chadwick Orevillo
AU  - Earl St. Rose
AU  - Shannon Strom
AU  - Tracy Fischer
AU  - Michael Golden
AU  - Mervyn Thomas
AU  - Colin Reisner
TI  - Glycopyrrolate MDI demonstrates comparable efficacy and safety to tiotropium DPI in a randomized, double-blind, placebo-controlled phase 2b study in patients with COPD
DP  - 2011 Sep 01
TA  - European Respiratory Journal
PG  - p3975
VI  - 38
IP  - Suppl 55
4099  - http://erj.ersjournals.com/content/38/Suppl_55/p3975.short
4100  - http://erj.ersjournals.com/content/38/Suppl_55/p3975.full
SO  - Eur Respir J2011 Sep 01; 38
AB  - Rationale: Anticholinergics (LAMAs) are central to the management of patients with COPD. Tio (Spiriva® Handihaler® 18 μg), is a LAMA approved as a dry powder inhaler (DPI) for the treatment of COPD. The availability of a LAMA in an MDI formulation could provide a needed alternative method of administration. Pearl Therapeutics' proprietary porous particle technology allows the formulation of glycopyrrolate in an MDI format (GP-MDI). In a previous single-dose, Phase 2a study, GP-MDI showed comparable efficacy and safety to Tio. Based on these findings, Pearl evaluated GP-MDI compared to Tio in a chronic dosing study.Methods: In a randomized, double-blind, customized, unbalanced, incomplete block, crossover study conducted in patients with moderate to very severe COPD, GP-MDI 36 μg was compared to placebo (PL) and Tio (open-label). GP-MDI and PL were administered BID for 1 week; Tio was administered QD for 1 week. The primary efficacy endpoint was FEV1 AUC0-12 on Day 7 relative to pre-dose baseline at the start of treatment. Secondary endpoints included peak FEV1, morning trough FEV1, and safety assessments.Results: GP-MDI 36 μg and Tio were superior to PL for the primary endpoint (189 and 195 mL respectively, P<0.0001 all comparisons). GP-MDI 36 μg was non-inferior to Tio for this endpoint (mean difference = -6 mL, 95% CI: -49, +38 mL). Secondary endpoints confirmed the overall efficacy of GP-MDI and Tio. GP-MDI 36 μg was safe and well tolerated with a similar safety profile to Tio.Conclusion: Pearl's GP-MDI 36 μg demonstrated comparable efficacy and safety to Tio, supporting further development in patients with COPD.