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Three-Year Trial Confirms Benefits of Inhaled Corticosteroids/Long-Acting Beta-Agonists in COPD: Presented at ERS

By Paula Moyer

MUNICH, GERMANY -- September 14, 2006 -- Treatment that combines inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) results in improvements in several parameters of chronic obstructive pulmonary disease (COPD), according to a multinational study.

Investigator Bartolome Celli, MD, head, pulmonary and critical care medicine, St. Elizabeth's Medical Center, Boston, Massachusetts, presented the findings of the Towards a Revolution in COPD Health (TORCH) study here on September 6^th at the 16^th annual meeting of the European Respiratory Society (ERS).

To date, no trials have assessed the effect of inhaled corticosteroids and long-acting bronchodilators, alone or in combination, on mortality in patients with COPD, despite their known benefit in reducing symptoms and exacerbations.

"COPD treatment needs to reduce exacerbations and to improve quality of life and lung function," said in a presentation. "If not, improved survival is of less relevance."

With the aim of finding a treatment for COPD that would have a beneficial effect on quality of life and lung function, Dr. Celli and co-investigators recruited 6,112 patients with COPD to participate in the 3-year, double-blind, placebo-controlled TORCH study. Patients were an average of 65 years old and 76% were men.

Average postbronchodilator forced expiratory volume in 1 second (FEV₁) was 44% of predicted; 43% of subjects were current smokers and 3.7% had reversibility when treated with the short-acting beta-agonist salbutamol.

Patients were randomized to receive treatments as follows: 1,521 received 50 mcg of salmeterol twice daily; 1,534 received 500 mcg of fluticasone propionate twice daily; 1,533 received salmeterol/fluticasone twice daily; and 1,524 received placebo.

The study's primary endpoint was all-cause mortality and secondary endpoints were rate of COPD exacerbations and health status. Other endpoints were long-term oxygen therapy requirement and lung function measured at clinic visit. Safety endpoints are adverse events, with specific information gathered on bone fractures.

Results showed that patients on the combination treatment had fewer COPD exacerbations, improved lung function, and better quality of life compared to those on placebo, as well as compared with those who received either of the drugs as monotherapy.

Another key finding of TORCH was improved survival, said Dr. Celli, who was the principal investigator of one component of the TORCH study.

In this component of TORCH, the investigators were particularly interested in the patients' health status as assessed by the St George's Respiratory Questionnaire (SGRQ). Moderate to severe exacerbations and lung function were gauged by post-bronchodilator FEV₁. Moderate exacerbations required antibiotics, systemic corticosteroids, or both. Severe exacerbations required hospitalization.

Patients on the combined treatment had an SGRQ score that was an average of 3.1 units lower than those on placebo (P < .001), 2.2 units lower than those on salmeterol monotherapy (P < .001), and 1.2 units lower than those on fluticasone monotherapy (P = .017).

Combined treatment was associated with 25% fewer exacerbations than those on placebo (P <.001), 12% fewer than those on salmeterol (P = .002), and 9% lower than those on fluticasone (P = .024).

Post-bronchodilator FEV₁ was 92 mL higher with combination therapy than with placebo, 50 mL higher than with salmeterol alone, and 44 mL higher than with fluticasone alone (P < .001 for each).

Advair/Seretide is manufactured by GlaxoSmithKline, which funded the study.


[Presentation title: The TORCH (TOwards a Revolution in COPD Health) Study: Salmeterol/Fluticasone Propionate (SFC) Improves Health Status, Reduces Exacerbations and Improves Lung Function Over Three Years. Abstract E312]

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