Pneumologie 2015; 69 - P351
DOI: 10.1055/s-0035-1544792

Effect of aclidinium bromide/formoterol fumarate fixed-dose combination on exacerbations in moderate-to-severe COPD: Pooled analysis of two studies

ED Bateman 1, S Rennard 2, PW Jones 3, E Molins 4, V Mergel 5, A Leselbaum 4
  • 1Department of Medicine, University of Cape Town
  • 2University of Nebraska Medical Center
  • 3Division of Clinical Sciences, St George's, University of London
  • 4Almirall R&D Centre Barcelona
  • 5Forest Research Institute, a subsidiary of Actavis plc, Jersey City, NJ

Background: Aclidinium/formoterol 400/12 µg fixed-dose combination (FDC) is in development for the treatment of COPD. We present pooled COPD exacerbation data from two Phase III studies.

Methods: ACLIFORM and AUGMENT were 24-week, randomized, double-blind Phase III studies of aclidinium/formoterol FDC in patients with moderate-to-severe COPD. Treatment arms were FDC 400/6 µg, FDC 400/12 µg, aclidinium 400 µg, formoterol 12 µg or placebo (all twice-daily via Genuair®/Pressair® inhaler). Prior exacerbation was not an inclusion criterion. Healthcare resource utilization (HCRU; symptom increase on ≥2 consecutive days requiring treatment change) and the EXAcerbations of Chronic pulmonary disease Tool (EXACT; increase ≥9 points for ≥3 days or ≥12 points for ≥2 days) were used to assess COPD exacerbations.

Results: The pooled population included 3398 patients (mean age 63.5 years, 60.5% male, 58.6% GOLD stage II, 40.8% stage III). Exacerbation rate was significantly reduced vs placebo following treatment with FDC 400/12 µg (moderate-severe HCRU by 29%; p < 0.05 and EXACT by 22%; p < 0.01). FDC 400/12 µg also resulted in delayed time to first exacerbation vs placebo (hazard ratio 0.70 [moderate-severe HCRU] and 0.79 [EXACT]; both p < 0.05).

Conclusions: Aclidinium/formoterol 400/12 µg FDC reduced the rate of both HCRU- and EXACT-defined COPD exacerbations in a study population where prior exacerbation was not an inclusion criterion.

Tab. 1: Annualized COPD exacerbation rates

*p < 0.05 vs placebo; **p < 0.01 vs placebo

EXACT, EXAcerbations of Chronic pulmonary disease Tool; FDC, aclidinium bromide/formoterol fixed dose combination via the Genuair®/Pressair® multiple dose dry powder inhaler; HCRU, healthcare resource utilization.

Genuair® and Pressair® are registered trademarks of Almirall S.A., Barcelona, Spain, for use within the United States as Pressair® and Genuair® within all other licensed territories


(n = 526)

FDC 400/6 µg

(n = 714)

FDC 400/12 µg

(n = 720)

HCRU exacerbation rate





Rate ratio vs placebo




HCRU exacerbation rate





Rate ratio vs placebo




EXACT exacerbation rate




Rate ratio vs placebo




Funding statement: This study was supported by Almirall S.A., Barcelona, Spain and Forest Laboratories LLC, a subsidiary of Actavis plc, New York, NY, USA.