Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
An Investigation of the Efficacy, Tolerability and Safety of a Range of Doses of Orally Inhaled Glycopyrronium Bromide (PSX1002-GB pMDI) in Male and Female Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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