LABA/ICS betters LABA in moderate and severe COPD

AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta₂-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV₁). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV₁ percent predicted of at least 50%, and severe disease was defined as FEV₁ percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.

AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta₂-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV₁). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV₁ percent predicted of at least 50%, and severe disease was defined as FEV₁ percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.

AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta₂-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV₁). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV₁ percent predicted of at least 50%, and severe disease was defined as FEV₁ percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.