Disease progression and age-related loss of lung elastic recoil in chronic obstructive pulmonary disease (COPD) patients result in steadily increased airflow limitation. Age effects on response to budesonide/formoterol pressurized metered-dose inhaler (pMDI) were evaluated.
Two randomized, double-blind, multicenter studies (study I: 6-month; NCT00206154 [Tashkin et al. Drugs. 2008;68:1975]; study II: 12-month; NCT00206167 [Rennard et al. Drugs. 2009;69:549]) were conducted in moderate to very severe COPD patients ≥ 40 years. Changes from baseline (last predose FEV1 before randomized treatment) to treatment average in predose and 1-hour postdose FEV1 were assessed post hoc in 3 age groups: 40–64, 65–74, ≥ 75 years. Treatments included twice-daily budesonide/formoterol pMDI 320/9μg, budesonide/formoterol pMDI 160/9μg, budesonide pMDI 320μg + formoterol dry powder inhaler (DPI) 9μg (study I only), budesonide pMDI 320μg (study I only), formoterol DPI 9μg, placebo.
Mean baseline predose FEV1 (L) decreased with age (1.06–1.14, 0.95–1.02, and 0.85–1.02 for patients 40–64 [study I, n = 907; study II, n = 1083], 65–74 [study I, n = 587; study II, n = 661], and ≥ 75 years [study I, n = 203; study II, n = 220], respectively). No consistent effect of age group on screening percentage predicted FEV1 (33.3%–35.4%, 32.1%–35.8%, 31.8%–36.4%, respectively) or percentage reversibility (14.9%–19.4%, 13.4%–19.8%, 13.1%–20.4%) was observed. Improvements in predose and postdose FEV1 for the indicated dose of budesonide/formoterol (320/9μg) were greater (predose: 12.1%–12.7%, 8.0%–9.8%, 5.8%–10.4%, respectively; postdose: 23.1%–27.0%, 20.6%–22.0%, 19.7%–21.6%) versus placebo (predose: 2.8%–4.5%, 0.0%–2.0%, −0.5%–1.7%; postdose: 5.1%–6.0%, 3.3% [both studies], 2.3%–6.2%). Percentage improvements generally were greater in 40–64 year olds; however, age-by-treatment interaction term on absolute mean changes was not significant.
Predose and postdose FEV1 improved with the indicated budesonide/formoterol pMDI dose in all age groups.
Older COPD patients (≥ 75 years) had lower baseline FEV1, similar screening percentage predicted FEV1, and lower percentage improvements in predose and postdose FEV1 with budesonide/formoterol pMDI versus younger patients. However, no effect of age group on absolute improvements was observed.
Stephen Rennard, Grant monies (from industry related sources) AstraZeneca, Biomark, Centocor, Novartis; Consultant fee, speaker bureau, advisory committee, etc. Almirall, Aradigm, AstraZeneca, Boehringer Ingelheim, Defined Health, Dey, Eaton Associates, GlaxoSmithKline, Medacorp, Mpex, Novartis, Nycomed, Otsuka, Pfizer, Pulmatrix, Theravance, United Biosource, Uptake Medical, Vantage Point; Other Speaker for AstraZeneca, Novartis, Netrowk for Continuing Education, Pfizer, SOMA; No Product/Research Disclosure Information