Bioavailability of Terbutaline via M3 compared to M2 turboinhaler
Research type
Research Study
Full title
An Open-label, Single-dose, 2-period Cross over Study in Healthy Male and Female Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler (New Version) Compared with the M2 Turbuhaler (Current Version)
IRAS ID
156464
Contact name
James Ritter
Contact email
Sponsor organisation
Astra Zeneca
Eudract number
2014-001261-27
Research summary
The purpose of this study is to see what the differences are between administration of terbutaline using two different turboinhalers; Bricanyl Turboinhaler M3 device (new version) and Bricanyl Turboinhaler M2 device (current version).
Terbutaline is used as a relief medication during an acute asthma attack and it has been in use for over 30 years.
The M2 device is approved in Europe, but the M3 device is not. The purpose of this study is to confirm that the M3 device is as safe as the M2 device.
This study will involve 4 visits (screening visit, two admission visits of 2 nights and 3 days and a follow-up visit).
The volunteers will receive the M2 device in one period and the M3 device in the second period in a random manner.
Volunteers will be discharged on day 2 of each treatment period provided there are no safety concerns. They will return for a final follow-up visit 2 to 14 days after the last administration of the study drug.REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1080
Date of REC Opinion
10 Jul 2014
REC opinion
Favourable Opinion