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Aclidinium Bromide via Multidose Dry Powder Inhaler Effective, Safe for COPD: Presented at ERS

By Evelyn Harvey

VIENNA, Austria -- September 22, 2009 -- Aclidinium bromide improves lung function and reduces exacerbations in patients with chronic obstructive pulmonary disorder (COPD), researchers stated here at the 19th Annual Congress of the European Respiratory Society (ERS).

Stephen Rennard, MD, University of Nebraska, Lincoln, Nebraska, presented the results of the international phase 3 Aclidinium Clinical Trial Assessing Efficacy and Safety in Moderate to Severe COPD Patients (ACCLAIM) here on September 15 at a poster presentation.

The trial compared the long-term safety and efficacy of aclidinium bromide with placebo in 804 patients with COPD who were randomised to receive aclidinium bromide 200 mcg once daily via a multidose dry powder inhaler (n = 600) or placebo (n = 204) for 52 weeks.

All patients were diagnosed with moderate to severe COPD, with a post-bronchodilator forced expiratory volume in 1 second (FEV₁) <80% of predicted levels and a smoking history of >=10 packs per year. None of the patients had asthma, atopy, or any clinically relevant cardiovascular conditions.

Concomitant treatment with salbutamol was permitted, as was stable use of inhaled, oral, and parenteral corticosteroids. Baseline characteristics did not differ significantly between the placebo and treatment groups.

Compared with placebo, aclidinium treatment significantly improved mean trough FEV₁ at 4, 12, 28, and 52 weeks of treatment. At 12 and 28 weeks increases over placebo of 63 mL (P < .0001) and 59 mL were observed (P < .0002). The change from baseline FEV₁ was also greater in the aclidinium-treated patients (P < .001, all timepoints).

Time to first moderate-severe exacerbation was significantly delayed with aclidinium compared with placebo (hazard ratio = 0.7; P = .01). Scores from the St. George's Respiratory Questionnaire significantly improved in the aclidinium group, where a 13.4% increase in patients responding was observed up to 44 weeks (P < .01).

Withdrawal rates were 25.7% for the aclidinium group and 42.2% for the placebo arm, the majority due to lack of efficacy or patient request. Minor adverse events such as headaches and dry mouth were seen in both groups at similar rates. No significant differences in serious adverse event profiles were observed between groups, and of the 9 fatal serious adverse events that occurred, none were treatment related.

"The properties of aclidinium may allow for a novel treatment with the potential for sustained efficacy and fewer unwanted side effects," the authors commented.

Funding for this study was provided by Laboratorios Almirall and Forest Laboratories Inc.

[Presentation title: ACCLAIM/COPD II: Efficacy and Safety of Aclidinium Bromide, a Novel, Long-Acting Muscarinic Antagonist in COPD Patients, a Phase III Study. Abstract 4351]

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