Imaging of the lung with hyperpolarized xenon gas; investigations in patients with chronic obstructive pulmonary disease

Phase 1

• Conditions: MedDRA version: 18.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Chronic Obstructive Pulmonary Disease; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-002038-37-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

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.

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified