Finding studies
Finding studies
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Lead
Chiesi Farmaceutici S.p.A.
The study is divided into two parts: \- Part 1 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, single-dose escalation, alternating crossover design in two groups of COPD patients. Treatments to be administered on Part 1 (SD1, SD2, SD3, SD4, SD5, SP). The primary objective of Part 1 is the evaluation of the safety and tolerability of Glyco after single administration. \- Part 2 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, 4-period, 4-treatment, repeated dose cross-over design followed by an open-label extension period with tiotropium. Treatments administered on Part 2 (MD1, MD2, MD3, MP, Tiotropium). On the last treatment day in the morning, Formoterol 12 µg will be administered to all patients on top of placebo or Glyco or Tiotropium. The primary objective of Part 2 is the evaluation of the efficacy of Glyco after repeated administration. Part 2 will start after a safety review of the results obtained from Part 1.
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
