BACKGROUND: In the phase III, 52-week ETHOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF), at two inhaled corticosteroid dose levels, resulted in significantly lower moderate/severe exacerbation rates versus glycopyrrolate/formoterol fumarate (GFF) and budesonide/formoterol fumarate (BFF). Here, we report results from the ETHOS pulmonary function test (PFT) sub-study, which assessed lung function in a subset of ETHOS patients. METHODS: ETHOS (NCT02465567) was a randomized, double-blind, multi-center, parallel-group study in patients with moderate to very severe COPD who had experienced
- Rabe, K. F.
- Martinez, F. J.
- Singh, D.
- Trivedi, R.
- Jenkins, M.
- Darken, P.
- Aurivillius, M.
- Dorinsky, P.
Keywords
- *BGF metered dose inhaler
- *chronic obstructive pulmonary disease
- *inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist
- (ICS/LAMA/LABA)
- *pulmonary function
- *triple therapy
- Berlin-Chemie, Boehringer Ingelheim, Chiesi Pharmaceuticals, InterMune, Novartis,
- Sanofi, and Teva
- and grants from the Ministry of Education and Science, Germany,
- outside the submitted work. Fernando J Martinez reports grants from AstraZeneca
- during the conduct of the study
- personal fees and non-financial support from the
- American College of Chest Physicians, AstraZeneca, Boehringer Ingelheim, Chiesi
- Pharmaceuticals, Concert, Continuing Education, Genentech, GlaxoSmithKline, Inova
- Fairfax Health System, Miller Communications, the National Association for
- Continuing Education, Novartis, PeerView Communications, Prime Communications, the
- Puerto Rican Respiratory Society, Roche, Sunovion, and Theravance
- non-financial
- support from ProterixBio
- and personal fees from the American Thoracic Society,
- Columbia University, Haymarket Communications, Integritas, inThought Research, MD
- Magazine, Methodist Hospital Brooklyn, New York University, Unity, Up-To-Date,
- WebMD/MedScape, and Western Connecticut Health Network
- and grants from the National
- Institutes of Health, outside the submitted work. Dave Singh reports personal fees
- from Apellis, Cipla, Genentech, Peptinnovate, and Skyepharma
- and grants and
- personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi Pharmaceuticals,
- GlaxoSmithKline, Glenmark, Menarini, Merck, Mundipharma, Novartis, Pfizer,
- Pulmatrix, Teva, Theravance, and Verona, outside the submitted work. Roopa Trivedi,
- Martin Jenkins, Patrick Darken, Magnus Aurivillius, and Paul Dorinsky are employees
- of AstraZeneca and hold stock and/or stock options in the company.