Further Phase III data for potential COPD treatment

Researchers have reported mixed results from a second pivotal trial of aclidinium in patients with chronic obstructive pulmonary disease (COPD).

Cross sectional CT image of the chest in a person who smokes, showing changes typical of emphysema - a form of COPD.

The ACCORD COPD II study showed that treatment with aclidinium produced significant improvements in patients’ FEV1 values from baseline.

However, the changes in FEV1 seen with the higher dose tested were smaller than those observed in previous studies.

Aclidinium is a long-acting muscarinic receptor antagonist, or anticholinergic. These drugs are useful in COPD as cholinergic impulses from the vagal nerve are believed to be the only reversible component of the airway narrowing associated with the disease.

ACCORD COPD II randomised 544 patients with moderate to severe COPD to receive double-blind treatment with 200 or 400 microgram aclidinium, or placebo, twice daily for 12 weeks. Despite the significant improvements in morning trough FEV1 seen at both doses (p=0.019 and p=0.001, respectively), the 72ml improvement achieved with the higher dose relative to placebo was less than that observed in the ACCORD COPD I  trial.

Aclidinium was well tolerated, with a safety profile similar to that seen in other trials.

The drug is delivered via a novel multidose dry powder inhaler, called Genuair, which incorporates a range of features designed to ensure the patient has inhaled correctly and to prevent double-dosing or use of the inhaler when empty.

Results from the third pivotal study of aclidinium, ATTAIN, are expected in early 2011. Co-developers Forest Laboratories and Almirall plan to apply for marketing approval in mid-2011.

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