Phase I study to compare PK of tiotropium products (QCL117786)
Research type
Research Study
Full title
Phase I randomised, four-period balanced incomplete block design cross-over study in healthy male and female volunteers to compare the pharmacokinetics of tiotropium delivered from four test pMDI products with one reference product
IRAS ID
207723
Contact name
Lester Harrison
Contact email
Sponsor organisation
3M Drug Delivery Systems Division
Eudract number
2016-001142-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 15 days
Research summary
The Sponsor is developing test products that deliver tiotropium via inhalation methods. This is for the potential treatment of chronic obstructive pulmonary disease (COPD). The treatment investigated in this study could treat the narrowing of the airways associated with the disease.\n\nThe aim of this study is to determine how the body impacts the study drug tiotropium when it is given via four test inhalers, compared to when it is given via a reference inhaler. The secondary aim is to compare the rates of absorption and to summarise the safety profiles of the test and reference inhalers. \n\nThe study will consist of four sequential treatment periods where up to 45 healthy male and female subjects will receive four inhalations as a single dose of tiotropium from four of the five study inhalers (four test inhalers and one reference inhaler). They will receive 20mcg tiotropium from the test inhalers and 10 mcg from the reference inhaler. Doses will be separated by 12-19 days. For each dose administration, regular blood samples will be taken for 48 hours following dosing to allow determination of AUC0-∞.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0217
Date of REC Opinion
27 May 2016
REC opinion
Further Information Favourable Opinion