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| |  Nebulised Formoterol Improves Airway Function in COPD Subjects Receiving Maintenance Tiotropium: Presented at ERS By Chris Berrie BERLIN -- October 9, 2008 -- Addition of the fast- and long-acting beta2-agonist formoterol fumarate as a nebulised inhalation solution to maintenance tiotropium provides statistically significant and clinically meaningful improvements in pulmonary function without increased safety concerns, for patients with chronic obstructive pulmonary disease (COPD), according to a randomised, placebo-controlled, double-blind trial presented here on October 7th at the European Respiratory Society (ERS) 18th Annual Congress. The use and combinations of long-acting bronchodilators for maintenance treatment of patients with moderate to severe COPD are now recommended, particularly considering that combinations can provide improved bronchodilation over either agent alone. As it has been shown that formoterol fumarate inhalation solution can provide comparable efficacy to formoterol dry-powder inhalation, principal investigator Nicola Hanania, MD, Asthma Clinical Research Centre, Baylor College of Medicine, Houston, Texas, said, "The main purpose of this study was to see if the nebulised, long-acting, beta-agonist formoterol solution on top of standard therapy of the anticholinergic tiotropium will have added, mainly lung function, benefits for patients with COPD." The study enrolled 155 patients with moderate to severe COPD who were 40 years or older and had no significant comorbidities. These patients smoked 10 or more pack-years, and had postbronchodilator forced expiratory volume at 1 second (FEV1) of 25% to 65% predicted, an FEV1/forced vital capacity (FVC) of <0.70, and a predose FEV1 at randomisation of <70%. Patients all received open-label maintenance treatment with tiotropium 18 mcg QD and were randomised to receive 6 weeks of twice-daily nebulised placebo (n = 77) or nebulised formoterol 20 mcg BID (n = 78). These treatment groups were comparable for baseline characteristics. The primary efficacy endpoint was lung function at week 6 measured as standardised absolute FEV1 area under the curve at 0 to 3 hours (AUC0-3). Results show that lung function at week 6 was significantly improved in the formoterol group compared with the placebo group (1.57 vs 1.38 L; P < .0001; respectively). Similar improvements were also seen at week 6 in the standardised FVC AUC0-3 (3.13 vs 2.82 L; P < .0001), peak FEV1 (1.64 vs 1.48 L; P < .0001), peak FVC (3.29 vs 3.00 L; P < .0001), and peak inspiratory capacity (2.74 vs 2.51; P < .0001). The early effects (5 minutes to 3 hours) of formoterol addition to tiotropium on day 1 and at week 6 as compared with placebo/tiotropium were significant improvements in FEV1 (P <= .0003) and inspiratory capacity (P < .005). Measures of mean baseline/transition dyspnoea index, health status (St. George's Respiratory Questionnaire), and most symptom scores showed no significant changes at week 6, while formoterol significantly decreased the use of rescue albuterol/salbutamol over placebo throughout the study (P < .05). Safety evaluations for formoterol/tiotropium versus placebo/tiotropium show fewer exacerbations (2.6% vs 7.8%, respectively) and fewer adverse events (37% vs 51%). "We have demonstrated that as with the dry powder combination there is an additive effect on lung function compared to tiotropium alone that was seen on the first day and also at 6 weeks," Dr. Hanania said. Therefore, this research shows that for those patients where a nebulised delivery is advantageous or preferred, their choice will not affect the efficacy of their treatment. Funding for this study was provided by Dey LP.
[Presentation title: Nebulised Formoterol Improves Airway Function in COPD Subjects Receiving Maintenance Tiotropium. Abstract P3621]
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