Background: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends a short-acting bronchodilator or single long-acting bronchodilator as an initial pharmacological treatment for GOLD category A patients with COPD. We pooled data from the PINNACLE-1, -2, and -4 studies to evaluate the efficacy and safety of the dual bronchodilator fixed-dose combination glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), formulated using co-suspension delivery technology, in GOLD category A patients with moderate-to-very severe COPD. Materials and Methods: PINNACLE-1, -2, and -4 were Phase III, randomized, double-blind, parallel-group, multicenter studies (NCT01854645, NCT01854658, and NCT02343458). Patients received 24 weeks' treatment with GFF MDI 18/9.6 microg, glycopyrrolate (GP) MDI 18 microg, formoterol fumarate (FF) MDI 9.6 microg, or placebo MDI twice daily. GOLD category A patients were identified based on a COPD Assessment Test score of <10 and exacerbation history in the previous year (none/one not requiring hospitalization). Endpoints evaluated were change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1), peak change from baseline in FEV1 within 2 hrs post-dose, and adverse events (AEs). Results: The pooled intent-to-treat population comprised 729 GOLD category A patients. GFF MDI significantly improved morning pre-dose trough FEV1 at Week 24 versus GP MDI, FF MDI, and placebo MDI (least squares mean [LSM] differences 54 mL, 62 mL, and 188 mL, respectively; all p
Martinez, F. J.
Rabe, K. F.
Lipworth, B. J.
Arora, S.
Jenkins, M.
Martin, U. J.
Reisner, C.
Keywords
- *copd
- *bronchodilator
- *co-suspension delivery technology
- *lung function
- *muscarinic antagonist
- *beta2-agonist
- Chest Physicians, AstraZeneca, Boehringer Ingelheim, Chiesi, Concert, Continuing
- Education, Gala, Genentech, GlaxoSmithKline, Inova Fairfax Health System, Miller
- Communications, National Association for Continuing Education, Novartis, Pearl -
- a member of the AstraZeneca Group, PeerView Communications, Prime Communications,
- Puerto Rican Respiratory Society, Roche, Sunovion, and Theravance
- non-financial
- support from ProterixBio
- personal fees from American Thoracic Society, Columbia
- University, Haymarket Communications, Integritas, inThought Research, MD
- Magazine, Methodist Hospital Brooklyn, New York University, Teva, Unity,
- UpToDate, WebMD/MedScape, and Western Connecticut Health Network
- and grants from
- AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and National Institutes of
- Health. KFR reports personal fees from AstraZeneca, Berlin-Chemie, Boehringer
- Ingelheim, Chiesi Pharmaceuticals, InterMune, Novartis, Sanofi, and Teva
- and
- grants from the Ministry of Education and Science, Germany. BJL is one of a
- number of co-investigators on an AstraZeneca-sponsored grant received by the
- University of Dundee to support genomic studies in COPD. He has also received
- speaker fees from AstraZeneca
- payment for consulting and speaking from
- Boehringer Ingelheim and Chiesi
- grant support from Boehringer Ingelheim, Chiesi,
- and Janssen
- advisory board and speaker fees from Teva
- and consulting fees from
- Sandoz, Cipla, Dr Reddys, and Lupin. MJ, UJM, and CR are employees of AstraZeneca
- and hold stock and/or stock options in the company. The authors report no other
- conflicts of interest in this work.
