E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Obstructive Pulmonary Disease |
|
E.1.1.1 | Medical condition in easily understood language |
Respiratory gas exchange disease that leads to breathlessness, also sometimes known as emphysema. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009033 |
E.1.2 | Term | Chronic obstructive pulmonary disease |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
|
|
E.2.2 | Secondary objectives of the trial |
[All our objectives are included in the answer to question A10] |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with a diagnosis of COPD, with at least mild disease (stage II – IV on GOLD criteria classification, FEV1 <80% predicted and FEV1/ FVC <70%25) • Significant smoking history (>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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | 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. |
|
E.5.2 | Secondary end point(s) |
See above in primary endpoints |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
See above in primary endpoints |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |