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The SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) clinical development program consisted of six Phase 3 studies in 2663 patients with COPD (1308 receiving SPIRIVA HANDIHALER): two 1-year, placebo-controlled studies, two 6-month, placebo-controlled studies and two 1-year, ipratropium-controlled studies.

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At DEY, we are committed to developing effective new treatments for serious and complex diseases, and with Perforomist are proud to provide physicians and patients a twice-daily COPD maintenance medication that offers the flexibility of dosing via nebulization.

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We report here the results of two replicate, randomized, placebo-controlled trials, PrimoTinA-asthma 1 and PrimoTinA-asthma 2 (hereafter referred to as trial 1 and trial 2), in which we studied the efficacy and safety of adding tiotropium delivered by a soft-mist inhaler, as compared with placebo delivered by the same system, to a treatment regimen of glucocorticoids and LABAs.

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Common concomitant medications (LABA, ICS) used by patients with COPD were not found to alter the exposure to tiotropium.

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For the 11 patients in Group A, IOP increased significantly from before glucosamine supplementation to during glucosamine supplementation, and decreased significantly from during glucosamine supplementation to discontinuation of glucosamine.

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