1237.25 - Tiotropium/olodaterol vs tiotropium and placebo in COPD
Research type
Research Study
Full title
A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy and safety of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat® inhaler) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
133735
Contact name
Monica Nordstrom
Contact email
Eudract number
2013-002243-29
Research summary
The purpose of this study is to determine the effect of 12 weeks tiotropium + olodaterol fixed dose combination (2 doses), and tiotropium versus placebo on lung function in patients with moderate to severe COPD. This will be assessed using pulmonary functions tests, and patient questionnaires.
Patients will be randomised, following a successful screening period by IRT to one of 4 treatment arms: T+O 5μg/5μg, T+O 2.5μg/5μg, tiotropium 5μg and placebo. During the 12 weeks treatment patients will return to clinic 5 times. There will be a follow up period of 3 weeks after which the patients involvement in the trial will be over.
Since tiotropium and olodaterol work in different ways, combining the two medicines can open more airways than each medicine alone. Patients will be asked to participate in this trial to evaluate the investigational combination of tiotropium +olodaterol inhaled together in the same Respimat® device.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0805
Date of REC Opinion
16 Dec 2013
REC opinion
Favourable Opinion