Effects of new inhaled drug for COPD compared to placebo

• Research type

  Research Study

• Full title

  Randomized, double-blind, placebo-controlled, cross-over study to investigate the bronchodilator efficacy and safety after single and repeated administrations of different doses of Glycopyrrolate via pMDI in moderate to severe COPD patients

• IRAS ID

  53453

• Contact name

  Dave Singh

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2010-018668-18

• Research summary

  This is a phase II trial in moderate to severe COPD patients, divided into two parts. Part 1 is randomized, double blind, placebo controlled, single dose escalation alternating crossover study to assess the safety and tolerability of single administration of Glyco pMDI at 5 dose levels in patients with moderate to severe COPD. In Part 1, 24 patients will be divided into 2 (12 patients each) who will receive one single dose per study period according to a dose escalation. In each cohort, subjects will be randomised (10:2 ratio Glyco: placebo) in: ™ Cohort A will receive three dose levels: 12.5 μg, 50 μg and 200 μg™ Cohort B will receive two dose levels: 25 μg and 100 μg. Time between consecutive treatment periods will be about 7 days, but it may vary depending on the availability of the safety data and the time for evaluation and decision of the Study Safety Board. After the consent visit, Patients in cohort 1 will attend 5 visits (1 screening visit ?? 3 treatment periods ?? 1 follow up visit).Patients in cohort 2 will attend 4 visits (1 screening visit ?? 2 treatment periods ?? 1 follow up visit). Maximal study duration is 49 days (cohort 1)/42 days (cohort 2).Study is planned to start in July 2010 and end in October 2010.Part 2 will start after a safety review of Part 1 and will be a randomized, double-blind, placebo-controlled, 4-period, 4-treatment, repeated dose, cross-over design followed by an open-label extension period with tiotropium in order to evaluate the efficacy of Glyco pMDI at 3 dose levels in patients with moderate to severe COPD40 patients will be randomised for Part 2 (aim: 32 evaluable patients.)Part 2 comprises five 8-day repeated dose periods, separated by a 7day washout period. In the first 4 periods, subjects will take Glyco (3 dose levels) or placebo according to a crossover design. At the end, all subjects will then enter an 8-dayopenlabel extension period with tiotropium. After a consent visit, patients will attend in total 21 visits (screening visit ‘4 visits per study core periods’ 3 visits per study extension period - follow up visit).Last patient last visit is expected in Q3 of 2011.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/47

• Date of REC Opinion

  5 Jul 2010

• REC opinion

  Further Information Favourable Opinion