Jim Kling

November 03, 2014

AUSTIN, Texas — Aclidinium bromide maintains its effectiveness in moderate to severe chronic obstructive pulmonary disease (COPD) up to 52 weeks, according to an extension study.

The analysis was performed to satisfy the US Food and Drug Administration, "but physicians also want to know if it will still be working a year from when it's first prescribed," said Stephen Rennard, MD, from the University of Nebraska Medical Center in Omaha.

"I think the data support that it does," he told Medscape Medical News here at CHEST 2014.

The drug, a long-acting muscarinic receptor antagonist that helps relax the muscles around the large airways of the lungs, received FDA approval for COPD in 2012.

In the original 12-week ACCORD COPD II clinical trial, patients were randomized to receive aclidinium bromide 200 µg, aclidinium bromide 400 µg, or placebo (Clin Drug Investig. 2013;33:893-904).

During the 40-week extension trial, all patients were transitioned to aclidinium bromide 400 µg, and Dr Rennard and his team assessed adverse events.

They also evaluated changes from the baseline of the original trial to week 52 in trough forced expiratory volume in 1 second (FEV₁), peak FEV₁, and the Saint George's Respiratory Questionnaire (SGRQ) score.

The effectiveness of some shorter-acting drugs, such as short-acting beta-agonists, can drop off over time, but that does not appear to be the case for long-acting drugs like aclidinium, said Dr Rennard.

"For the other anticholinergics, I think it's been a consistent finding that there is no loss of effectiveness over time," he explained. "So this isn't a unique finding by any means, but it's still important."

Table. ACCORD COPD II Extension Study Outcomes

Outcome Aclidinium 200 µg Aclidinium 400 µg Placebo
Adverse events      
   Serious, % 13.0 9.5 10.2
   Mild to moderate, % 8.4 8.8 7.5
   Related discontinuations, % 6.5 4.8 6.8
Potential anticholinergic effects      
   Urinary tract infection, % 4.5 1.4 1.4
   Constipation, % 1.3 1.4 1.4
Change from baseline to week 52      
   FEV₁ trough, mL +29 +48 +44
   Peak FEV₁, mL +176 +172 +184
   SGRQ score –6.19 –6.82 –8.25

 

Aclidinium could be used as first-line therapy for COPD, even though it requires a twice-daily dose and there are once-daily drugs available, Dr Rennard suggested. "There are 25 million people in the United States with COPD, so for a clinician, having choices is really important."

There was a slight decrease in lung function in the extension trial, but it remained well above baseline values. "Maybe it's just the time period you're looking at; everybody has decline in lung function," said session moderator Linus Santo Tomas, MD, from the Medical College of Wisconsin in Milwaukee.

"The question is whether this is part of the normal decline that you might see in COPD patient," he told Medscape Medical News.

The nature of the extension study made it difficult to determine. "You don't have a placebo to compare with," said Dr Santo Tomas.

This study was funded by Almirall and Forest Laboratories. Dr Rennard has received honoraria for lectures from Almirall, Forest Laboratories, and a range of other companies. Dr Santo Tomas has disclosed no relevant financial relationships.

CHEST 2014: American College of Chest Physicians Meeting: Abstract 1959389. Presented October 27, 2014.

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