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Aclidinium, Formoterol Combination Superior in Stable COPD
Patients with stable, moderate-to-severe chronic obstructive pulmonary disease (COPD) treated with combination aclidinium and formoterol had significant improvement in bronchodilation compared to those treated with combination salmeterol and fluticasone.
The AFFIRM COPD (Aclidinium and Formoterol Findings in Respiratory Medicine COPD) study compared the efficacy and safety of twice-daily aclidinium bromide and formoterol fumarate with that of salmeterol and fluticasone propionate in patients with stable, moderate-to-severe COPD.
Furthermore, the study also concluded that the benefits to symptom control and reduction in exacerbation risk were equivalent between the two treatment regimens.
In the 24-week, double-blind, double-dummy, active-controlled study, 933 patients were randomized (1:1) to either aclidinium plus formoterol (400/12 ug twice daily via Genuair/Pressair) or to salmeterol plus fluticasone (50/500 ug twice daily via Accuhaler). The majority of the patients enrolled in the study were male (65.1%) with a mean age of 63.4 years.
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The primary endpoint of the study was peak forced expiratory volume in 1 s (FEV1) at week 24, with secondary endpoints included Transition Dyspnoea Index (TDI) focal score at week 24, TDI and St. George’s Respiratory Questionnaire (SGRQ) responders, COPD Assessment Test and SGRQ scores, assessment of COPD symptoms and exacerbations, use of reliever medication, and device preference.
Assessment of the primary endpoint of the study showed that aclidinium plus formoterol was superior to salmeterol and fluticasone with a mean improvement of 93 mL in peak FEV1 at week 24 compared to salmeterol and fluticasone.
The study also found that aclidinium plus formoterol was noninferior to salmeterol and fluticasone in TDI, and that reduction in exacerbation risk and health status were similar between the two treatment groups.
When assessing safety, the study found that pneumonia was less frequent in patients treated with aclidinium plus formoterol. Notably, both treatment regimens were well tolerated.
Currently, the aclidinium plus formoterol treatment combination used in the study is not available in the United States. Within the past 3 years, however, several inhaled formularies of this treatment combination for the treatment of COPD have been approved by the FDA. ---Mary Beth Nierengarten
References:
Boyles S. Novel LAMA/LABA combo shines for COPD. MedPage Today. August 20,2016.
