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Additive Effects of Salmeterol and Fluticasone or Theophylline in COPD^*

^* From A. Cardarelli Hospital (Drs. Cazzola, Di Perna, and Calderaro), Division of Pneumology and Allergology and Respiratory Clinical Pharmacology Unit, Naples; University of Palermo, Institute of Internal Medicine and Geriatrics (Dr. Di Lorenzo), Palermo; GlaxoWellcome Italy (Dr. Testi), Medical Department, Verona; and University of Milan (Dr. Centanni), San Paolo Hospital, Respiratory Unit, Milan, Italy.

Correspondence to: Mario Cazzola, Divisione di Pneumologia e Allergologia e Unità di Farmacologia Clinica Respiratoria, Ospedale A. Cardarelli, Via del Parco Margherita 24, 80121 Napoli, Italy; e-mail: mcazzola{at}qubisoft.it

Background: ß₂-Agonists and corticosteroids or theophylline can interact to produce beneficial effects on airway function in asthma, but this has not been established in COPD.

Methods: Eighty patients with well-controlled COPD were randomized to receive 3 months of treatment in one of four treatment groups: (1) salmeterol, 50 µg bid; (2) salmeterol, 50 µg, plus fluticasone propionate, 250 µg bid; (3) salmeterol, 50 µg, plus fluticasone propionate, 500 µg bid; and (4) salmeterol, 50 µg, plus titrated theophylline bid. At each visit, a dose-response curve to inhaled salbutamol was constructed using a total cumulative dose of 800 µg.

Results: A gradual increase in FEV₁ was observed with each of the four treatments. Maximum significant increases in FEV₁ over baseline values that were observed after 3 months of treatment were as follows: salmeterol, 50 µg bid, 0.163 L (95% confidence interval [CI], 0.080 to 0.245 L); salmeterol, 50 µg, plus fluticasone propionate, 250 µg bid, 0.188 L (95% CI, 0.089 to 0.287 L); salmeterol, 50 µg, plus fluticasone propionate, 500 µg bid, 0.239 L (95% CI, 0.183 to 0.296 L); and salmeterol, 50 µg, plus titrated theophylline bid, 0.157 L (95% CI, 0.027 to 0.288 L). Salbutamol always caused a significant dose-dependent increase in FEV₁ (p < 0.001), although the 800-µg dose never induced further significant benefit when compared with the 400-µg dose. The mean differences between the highest salbutamol FEV₁ after salmeterol, 50 µg, plus fluticasone propionate, 500 µg bid, and that after salmeterol, 50 µg, plus titrated theophylline bid or salmeterol, 50 µg bid, were statistically significant (p < 0.05).

Conclusion: These data show that both long-acting ß₂-agonists and inhaled corticosteroids have a role in COPD. The data also show that fluticasone propionate and salmeterol given together are more effective than salmeterol alone. Moreover, it suggests that the addition of fluticasone propionate to salmeterol allows a greater improvement in lung function after salbutamol, although regular salmeterol is able to improve lung function in COPD patients without development of a true subsensitivity to its bronchodilator effect. In any case, patients must be treated for at least 3 months before a real improvement in lung function is achieved.

Key Words: COPD • fluticasone propionate • salbutamol • salmeterol • theophylline • tolerance

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