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Fluticasone Propionate Plus Salmeterol More Efficacious Than Salmeterol Alone for Chronic Obstructive Pulmonary Disease: Presented at ATS

By Marvin Ross

TORONTO -- May 22, 2008 -- A combination of fluticasone propionate and salmeterol 250/50 (FSC) has greater efficacy than salmeterol alone for management of exacerbations of chronic obstructive pulmonary disease (COPD), according to a randomised, double-blind trial.

The study findings were presented here on May 18 at the 104th International Conference of the American Thoracic Society (ATS).

The study was conducted by Antonio Anzueto, MD, Professor, Department of Medicine-Pulmonary Division, University of Texas Health Center, San Antonio, Texas, and colleagues at 98 sites in the United States and Canada.

The goal of this study was to assess the effect of FSC 250/50 mcg twice daily versus salmeterol 50 mcg twice daily on the annual rate of moderate to severe exacerbations of COPD in patients who had a history of exacerbations.

Therapy was standardised to FSC 250/50 mcg twice weekly for a 4-week, open-label, run-in period, then patients were randomised to receive twice weekly therapy with either FSC 250/50 mcg or salmeterol 50 mcg for 52 weeks.

Study subjects were diagnosed with COPD but did not have asthma; age was 40 years or more. Patients had a forced expiratory volume in 1 second (FEV₁) no greater than 50% of predicted normal and a ratio of pre-albuterol FEV₁ to forced viral capacity no greater than 0.7. All patients had a documented history of at least one COPD exacerbation that required treatment with oral corticosteroids, antibiotics, or hospitalisation in the year prior to study entry.

Use of concurrent inhaled long-acting bronchodilators ipratropium/albuterol combination products, oral beta agonists, and theophylline preparations was not permitted during the treatment period. Oral corticosteroids and antibiotics were permitted for acute treatment of COPD exacerbations.

Of 394 patients in the FSC 250/50 arm and 403 patients in the salmeterol arm, 269 (68%) and 247 (61%) completed the study.

FSC 250/50 reduced the rate of annual exacerbations by 30% compared with salmeterol. The number of patients with 1 or more moderate/severe exacerbations was 208 in the FSC 250/50 arm and 234 in the salmeterol arm.

The total number of moderate/severe exacerbations was 352 for FSC and 440 for salmeterol. The mean annual rate was 1.10 and 1.59 exacerbations (P < .001).

In addition, the FSC 250/50 patients required 34% less need for the administration of oral corticosteroids (P < .001).

FSC 250/50 significantly improved diary symptoms scores for dyspnoea, decreased night-time awakenings due to COPD, and decreased albuterol use compared with salmeterol over weeks 1 to 52 (P <= .032).

Adverse events were similar at 87% and 85% in the FSC 250/50 and salmeterol groups, respectively. Events of reported pneumonia, candidiasis, and upper respiratory infections were more common in the FSC patients (7%, 6% and 10% respectively). The incidence of eye (<1%), and bone disorders was low (3%-4%) and reported for a similar number of patients in both groups.

[Presentation title: A Randomized, Double-Blind Trial Comparing the Effect of Fluticasone/Salmeterol 250/50 With Salmeterol on COPD Exacerbations. Poster D40]

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