Budesonide/Formoterol pMDI Inhaler Reduces COPD Exacerbations

Troy Brown

December 29, 2011

December 29, 2011 — A budesonide/formoterol pressurized metered dose inhaler (pMDI) reduced chronic obstructive pulmonary disease (COPD) exacerbations more effectively than a formoterol dry powder inhaler, according to a recent study published online October 26 and in the February 2012 issue of Respiratory Medicine.

Amir Sharafkhaneh, MD, from the Section of Pulmonary, Critical Care, and Sleep Medicine, Baylor College of Medicine, Houston, Texas, and colleagues evaluated 2 doses of twice-daily budesonide/formoterol (320/9 μg and 160/9 μg) pMDI vs formoterol dry powder inhaler 9 μg in a study sponsored by AstraZeneca LP.

"This study is the first designed specifically to evaluate the long-term effect of budesonide/formoterol pMDI on COPD exacerbations relative to formoterol alone," the authors write.

Dr. Sharafkhaneh and colleagues conducted a randomized, double-blind, double-dummy, parallel-group, 12-month multicenter study from January 2007 to August 2009 at 180 sites in the United States (106), Central and South America (53), and South Africa (21).

They enrolled 1219 patients, aged 40 years or older, with COPD and a history of repeated exacerbations in the study. All patients completed a 2-week run-in during which they discontinued all medications except inhaled corticosteroids (ICSs).

Study participants were randomly assigned to receive twice-daily budesonide/formoterol pMDI 320/9 μg, budesonide/formoterol pMDI 160/9 μg, or formoterol dry powder inhaler 9 μg.

The researchers defined exacerbation as a worsening of COPD requiring oral corticosteroids and/or hospitalization. In addition, they performed a post hoc analysis in which they included antibiotic treatment in the exacerbation definition.

Dr. Sharafkhaneh and colleagues analyzed morning and evening peak expiratory flow, predose forced expiratory volume in 1 second, and predose forced vital capacity. Patients recorded symptoms (dyspnea, cough, and sputum scores; nighttime awakenings caused by COPD symptoms; and use of rescue medications) in an electronic diary.

Budesonide/formoterol reduced exacerbation rates (number of exacerbations per patient-treatment year) by 34.6% (budesonide/formoterol 320/9 μg) and 25.9% (budesonide/formoterol 160/9 μg) vs formoterol (P ≤ .002).

The 320/9 μg budesonide/formoterol dose prolonged time to first exacerbation compared with formoterol, corresponding to a 21.2% risk reduction (hazard ratio, 0.788; 95% confidence interval, 0.639 - 0.972; P = .026).

Exacerbation rates including antibiotic treatment (post hoc analysis) were reduced by 25.9% (budesonide/formoterol 320/9 μg) and 18.7% (budesonide/formoterol 160/9 μg) vs formoterol (P ≤ .023).

Pneumonia adverse events occurred in 6.4% (320/9 μg), 4.7% (160/9 μg), and 2.7% (formoterol) of study participants.

"These results are quite similar to results of previous studies," Norman H. Edelman, MD, chief medical officer of the American Lung Association, told Medscape Medical News in a telephone interview. One major adverse effect of this treatment is an increased incidence of pneumonia, he added.

"Overall, these results demonstrated that ICS/[long-acting β2-agonist (LABA)] combination treatment provides clinical benefits beyond a LABA alone in the management of COPD exacerbations, supporting the use of ICS/LABA combination treatments in patients with COPD and a history of previous exacerbations," the authors write.

This combination of inhaled steroid and long-acting bronchodilator is effective in reducing exacerbations, but it is unclear whether or not it extends life in patients with severe COPD, Dr. Edelman concluded.

Dr. Sharafkhaneh, MD, PhD, is on the speakers bureaus of AstraZeneca LP, GlaxoSmithKline, Pfizer, and DEY Pharmaceuticals. John G. Southard, MD, PhD, One coauthor is on the speaker bureaus for AstraZeneca LP and GlaxoSmithKline. Three coauthors are employees of the sponsor and participated in the conception and design of the study, as well as the analysis or interpretation of the data. They also revised the article for important intellectual content and provided final approval of the version to be submitted. Dr. Edelman has disclosed no relevant financial relationships.

Respir Med. 2012;106:257-268. Abstract


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