The effects of multiple doses of TD-4208 for 7 days in COPD

• Research type

  Research Study

• Full title

  A Phase 2, Randomised, Double-Blind, Multiple-Dose, Five-Period, Incomplete-Block, Crossover Study to Examine the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Multiple Doses of TD-4208 for 7 Days in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease

• IRAS ID

  117746

• Contact name

  S D Singh

• Sponsor organisation

  Theravance Inc.,

• Eudract number

  2012-004949-32

• Research summary

  This is a multiple-dose, randomised, double-blind, placebo-controlled, incomplete-block, five-period crossover study in subjects diagnosed with COPD. Study treatments are to be administered once daily for 7 days in each of the five periods: each subject will receive four of six possible doses of TD-4208 (22 æg, 44 æg, 88 æg, 175 æg, 350 æg, or 700 æg) and placebo. Approximately 60 subjects will be enrolled. The primary objective of the study is to characterise the dose response curve of TD-4208 after 7 days of dosing in subjects with COPD with the intent to identify an effective dose, a minimal-effect dose, and a no-effect dose, measured by spirometry (forced expiratory volume in 1 second [FEV1]).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0836

• Date of REC Opinion

  14 Dec 2012

• REC opinion

  Favourable Opinion