Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Methodology Study to Investigate the Use of 3He-MRI Lung Ventilation and Proton MRI Perfusion Imaging to Detect Changes in Ventilation Perfusion Relationships in Chronic Obstructive Pulmonary Disease (COPD) Patients; a Proof of Concept Study.
This protocol describes the investigation of the use of hyperpolarised helium magnetic
resonance imaging (MRI) in reflecting the regional differences in lung function of moderate
to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Since finalisation of the original protocol, new medications for COPD have received Market
Authorisation Approvals. Protocol Amendment 02 has been prepared to include these
medications in the protocol eligibility criteria and restrictions for the study.
Chronic Obstructive Pulmonary Disease (COPD) is an important cause of morbidity, mortality,
and healthcare costs worldwide. COPD is characterized by progressive airflow limitation that
is not fully reversible and is associated with an abnormal inflammatory response of the
lungs to noxious particles or gases. It has become clear that simple measures of airflow
obstruction are inadequate to relate lung function to exercise capacity or symptoms, and
that complex expressions such as dynamic hyper-inflation need to be invoked in seeking to
understand overall physiology. In addition to abnormalities of air flow, gas exchange is
also deranged. Therefore in considering new treatment approaches, both abnormalities need to
be addressed.
Techniques to study ventilation variation and perfusion matching across the lung exist but
are invasive and exacting, and do not give an indication of the anatomical distribution of
changes. There is a clear need for techniques which can provide sensitive, useful and safe
repeated measures reflecting regional changes in ventilation and gas exchange in COPD. This
study investigates use of hyperpolarised helium magnetic resonance imaging (MRI) in
reflecting the regional differences in lung function of moderate to severe COPD patients. A
Beta2 bronchodilator - Salbutamol - and a anticholinergic - Ipratropium - will be used in
this study.
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