Reisner C et al. – In this article, the authors reported the results of 2 phase IIIb crossover studies (PT003011 [N = 75] and PT003012 [N = 35]) that investigated 24–hour lung function profile of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI 18/9.6 ?g, which was delivered using innovative co–suspension delivery technology) administered twice daily in patients with chronic obstructive pulmonary disease (COPD). GFF MDI was found to significantly improve the 24–hour lung function in patients with moderate–to–very severe COPD when compared with placebo. A similar benefit was observed in the second 12–hour period compared to the first, which supports twice daily dosing of GFF MDI.

Methods

• GFF MDI, placebo MDI, and open–label tiotropium (PT003011 only) were administered to patients with moderate–to–very severe COPD in a 4 weeks’ treatment period.
• Lung function was evaluated over 24 hours on day 29 of each treatment period.

Results

• Forced expiratory volume in 1 second area under the curve from 0 to 24 hour (FEV1AUC0–24) (primary outcome) significantly increased, with similar improvements in GFF MDI when compared with placebo in both the studies over 0 to 12 and 12 to 24 hours.
• In PT003011, improvements in FEV1AUC with GFF MDI versus tiotropium were greater during 12 to 24 hours compared with 0 to 12 hours.
• There was a significant reduction in the use of rescue medication with GFF MDI compared with both placebo and tiotropium.
• Results from a post–hoc analysis suggested that patients with GFF MDI were more likely to attain a >15% increase from baseline in inspiratory capacity than patients treated with placebo or tiotropium.
• No significant safety or tolerability observations were reported.