Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
This is an investigation of the beneficial effects, tolerability and safety of a range of
single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female
patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long
term and progressive disease of the lungs, generally caused by cigarette smoking, but other
factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in
dilating the constricted airways of such patients, with a duration of action variously
described as being between 12 and 24 hours.
This study will investigate how well tolerated and safe this medication is at a range of
doses. It will also help in the selection of a suitable dose for larger and repeat dose
studies, based on measures of lung response. It will also help to determine how often the
medication should be given; twice daily, or once daily.
Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age.
Patients will be medically assessed before participation to ensure their suitability. The
study will take place in one centre in the UK over five sessions; at each session one dose (2
puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler
device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung
function will be measured for up to 26 hours after the administration of each dose using
standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the
blood levels of GB. There will be a period of about a week between each dosing session.
Patients will be medically reviewed after the study to confirm that no untoward effects are
present.