Clinical potential of aclidinium bromide in chronic obstructive pulmonary disease

Figures & data

Table 1 Recent clinical studies on the safety profile of aclidinium bromide

Subjects	n (age, years)	Dosage (μg) and duration	Side effects (n, relationship to dose if available)	Reference
Healthy	16 (range 18–65)	600, 1,200, 1,800, 2,400, 3,000, 3,600, 4,200, 4,800, 5,400, 6,000 Single dose 3 days 7-day washout	Headache (9) Fatigue (5) Renal pain (3) Dry mouth (1) Airway obstruction (1) Laryngitis (2) Epistaxis (2) Acne (2)	Jansat et al^Citation12
Healthy	272 (range 18–45)	200, 800 Placebo Single dose 3 days	None	Lasseter et al^Citation18
COPD FEV1 >30% and <80% FEV1/FVC <70%	12 (range 40–59) 12 (>70)	200, 400 Placebo Single dose 3 days 7-day washout	Headache (4/3) Fatigue (5/5) Dyspnea (2/1)	de la Motte et al^Citation11
COPD FEV1 >30% and <80% FEV1/FVC <70%	27 (mean age 58)	Aclidinium 400 twice daily Tiotropium 18 once daily Placebo 15 days 9–15 days washout	Diarrhea, flatulence, pruritus, cough, pneumonia, syncope, contusion, fatigue, extremity pain	Fuhr et al^Citation24
COPD FEV1 >30% and <80% FEV1/FVC <70%	602 (>40)	200, 400 Twice daily 52 weeks	Headache (11/11) Dry mouth (4/8) Dyspnea (8/2) Cardiac (24/12)	Gelb et al^Citation20
COPD	291 (mean age 63.6)	200, 400 Placebo Twice daily 52 weeks	Headache (3/3) Dyspnea (5/2) Cardiac (0/1)	D’Urzo et al^Citation19
COPD FEV1 >30% and <80% FEV1/FVC <70%	414 (mean age 62)	Aclidinium 440 twice daily Tiotropium 18 once daily Placebo 6 weeks	Not described	Beier et al^Citation25

Abbreviations: COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in one second; FVC, forced vital capacity.

JansatJMLamarcaRGarcia GilEFerrerPSafety and pharmacokinetics of single doses of aclidinium bromide, a novel long-acting, inhaled antimuscarinic, in healthy subjectsInt J Clin Pharmacol Ther200947746046819640353

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LasseterKCAubetsJChuecosFGilEGAclidinium bromide, a long-acting antimuscarinic, does not affect QT interval in healthy subjectsJ Clin Pharmacol201151692393220959525

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de la MotteSBeierJSchmidKPascualSJansatJMGilEGPharmacokinetics and safety of aclidinium bromide in younger and elderly patients with chronic obstructive pulmonary diseaseInt J Clin Pharmacol Ther201250640341222541745

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FuhrRMagnussenHSaremKEfficacy of aclidinium bromide 400 μg twice daily compared with placebo and tiotropium in patients with moderate to severe COPDChest2012141374575221903737

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GelbAFTashkinDPMakeBJZhongXGarcia GilECaractaCLAS-MD-35 Study InvestigatorsLong-term safety and efficacy of twice-daily aclidinium bromide in patients with COPDRespir Med2013107121957196523916502

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D’UrzoAKerwinERennardSHeTGilEGCaractaCOne-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPDCOPD201310450051023679347

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BeierJKirstenAMMrûzREfficacy and safety of aclidinium bromide compared with placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease: results from a 6-week, randomized, controlled Phase IIIb studyCOPD201310451152223819698

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