Chronic Obstructive Pulmonary Disease MedDRA version: 18.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Hyperpolarized xenon gas
Product Code: HypXe
Pharmaceutical Form: Medicinal gas, compressed
INN or Proposed INN: Hyperpolarized xenon gas
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with a diagnosis of COPD, with at least mild disease (stage II – IV on GOLD criteria classification, FEV1 15 pack years, where a pack year is the product of [average number of cigarettes smoked per day] and [number of years smoked for] divided by 20) or other definite cause of COPD • Patients over the age of 18 who are willing and able to give informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Co-existent cardio-pulmonary disease that predominates over COPD and might confound results interpretation (for example asthma, bronchiectasis, cystic fibrosis, lung cancer, uncontrolled heart failure, frequent unstable angina, respiratory muscle weakness) • Other major co-morbidity such that life expectancy is less than 24 months due to a cause other than COPD • Pregnancy Exclusion criteria for CT scanning • Inability to lie flat Exclusion criteria for MR imaging • Inability to lie flat • Severe claustrophobia • Presence of a cardiac pace-maker or non-MRI compatible metallic implant • Intra-ocular foreign body • Epilepsy requiring on-going medical treatment, or a seizure within the past year Exclusion criteria for gadolinium enhanced lung MRI scanning • Known hypersensitivity/ allergy to the injection of MultiHance that is given as part of this scanning or an adverse reaction to an injection given during previous MRI scanning. MultiHance contains gadobenate dimeglumine and small quantities of benzyl alcohol. • Severe renal impairment Exclusion criteria for ventilation/perfusion nuclear medicine scanning • Known hypersensitivity to albumin or preference to avoid blood donation product Exclusion criteria for salbutamol intervention component of study • Known hypersensitivity to salbutamol or to any of the excipients • Inability to omit long acting bronchodilators for 24 hours prior to the start of the study, and short acting bronchodilators on the day of the study until measurements are complete.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our objective is to develop and use Xe-129 lung MRI, a regional non-ionising radiation based functional imaging tool for the evaluation of COPD. Specific aims are: (1) Technique development (2) Comparison to standard COPD assessment tools (3) Effects of salbutamol To test the effects of salbutamol on Xe-129 lung MRI imaging post -inhaled salbutamol (4) Interval imaging To evaluate the changes in Xe-129 lung MRI imaging occurring in patients over time. ;Secondary Objective: [All our objectives are included in the answer to question A10] ;Primary end point(s): Assessments to (1) further develop technical aspects of Xe-129 lung MRI, (2)compare with standard COPD assessment tools (3) evaluate changes in lung imaging post salbutamol (4) evaluate interval changes in imaging.;Timepoint(s) of evaluation of this end point: Evaluations will take place at approximately three monthly intervals, but this will depend on the number of exacerbations that each patient has. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): See above in primary endpoints;Timepoint(s) of evaluation of this end point: See above in primary endpoints | — |
Countries
United Kingdom
Outcome results
None listed