Scintigraphic study of inhaled 99mTc CHF5993 pMDI (QCL117799)
Research type
Research Study
Full title
Open label, uncontrolled, non-randomized, single dose, scintigraphic study to investigate lung deposition of inhaled 99mTc radiolabelled CHF5993 pMDI in healthy volunteers, asthmatic and COPD patients
IRAS ID
215190
Contact name
Ilaria Panni
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2016-001088-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 8 days
Research summary
The Sponsor is developing the study drug, CHF5993, for the potential treatment of patients with asthma and Chronic Obstructive Pulmonary Disease (COPD). Asthma is a lung condition where the airways swell and narrow causing coughing, wheezing, chest tightness and breathlessness. COPD is a term used to describe a group of lung diseases which can cause breathing difficulties and wheezing, a persistent cough with mucus and frequent chest infections.
The study will try to identify how much CHF5993 is found in the lungs following inhalation by healthy volunteers, asthmatic patients and COPD patients.
The study will consist of a single part involving up to 30 subjects. 10 healthy volunteers, 10 asthmatic patients and 10 COPD patients will be recruited. The subjects will receive a single dose of the radiolabelled study drug as four inhalations from an inhaler. ‘Radiolabelled’ means that the test drug has a radioactive component which helps researchers to track where the drug is in the body. On each inhalation, each participant will receive a dose of 100 mcg Beclometasone dipropionate, 6 mcg Formoterol Fumarate and 12.5 mcg Glycopyrronium bromide with a radioactivity of not more than 5 MBq. Therefore the total dose that participants will receive is 400 mcg Beclometasone dipropionate, 24 mcg Formoterol Fumarate and 50 mcg Glycopyrronium bromide with a radioactivity of not more than 20 MBq. Samples of blood and urine will be taken throughout the study to look at the concentrations of the radiolabelled drug in the body. Subjects will also be required to sit or stand in front of a gamma camera as part of the scintigraphic assessment. The gamma camera will be used to identify the presence and amount of the radiolabelled study drug in the lungs.
REC name
HSC REC A
REC reference
16/NI/0215
Date of REC Opinion
18 Nov 2016
REC opinion
Further Information Favourable Opinion