A study of Trimbow in NHV and Asthma/COPD patients
Research type
Research Study
Full title
Open label, uncontrolled, non-randomized, single dose, scintigraphic study to investigate lung deposition of inhaled 99mTc radiolabelled Trimbow® pMDI in healthy volunteers, asthmatic and COPD patients
IRAS ID
253724
Contact name
Ezanul Wahab
Contact email
Eudract number
2017-005030-29
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
This study is a single-dose, single treatment period, open-label, non-randomised gamma scintigraphy study investigating the deposition in the lungs of a beclometasone dipropionate, formoterol fumarate & glycopyrronium bromide pressurised metered dose inhaler (marketed as Trimbow).
This study will be conducted in both healthy volunteers and asthma/COPD patients. The study will investigate how the drug (Trimbow) is distributed in the lungs and will also investigate the drug concentration levels in the blood of the 3 active products in the inhaler.
This inhaler is marketed for the treatment and management of symptoms associated with Chronic Obstructive Pulmonary Disease (COPD), which is a group of diseases which cause lung problems and difficulty breathing.
Trimbow contains a combination of 3 marketed drugs; Beclometasone dipropionate, formoterol fumarate & glycopyrronium bromide.
All 3 drugs are well established and marketed for the management of symptoms associated with COPD.
To facilitate determination of how much of the drug gets into the lungs and the distribution pattern, a technique called gamma scintigraphy will be used. Gamma scintigraphy is a technique used to track the movement of a radiolabelled tracer inside the body.
In order to determine the levels of the 3 active drugs in the bloodstream, blood samples will be taken at set intervals following inhaler administration in order to measure the levels and how these change over time.The study will involve the following visits: 1 screening visit, 1 treatment visit (around 2 days in duration) and a post-study follow up phone call/visit 14-30 days after the dose administration.
The study will follow the same procedure for both healthy volunteers and asthma/COPD patients.The study population will be 10 healthy volunteers, 10 asthmatics and 10 COPD patients.
REC name
Wales REC 1
REC reference
18/WA/0350
Date of REC Opinion
8 Nov 2018
REC opinion
Favourable Opinion