None listed
Conditions
Brief summary
The purpose of this research study is to determine the changes in lung ventilation using a new imaging technique before and after inhalation of a bronchodilator that opens the airways, and before and after inhalation of a stimulant that narrows the airways in asthma and COPD patients. In this study you will perform several standard lung function tests and you will undergo lung imaging to assess lung ventilation during a total of 3 visits. We predict that the outcomes of this study will contribute to further characterisation of asthma and COPD and will support the use of this imaging technique as a new clinical tool to measure responses to new treatments.
Interventions
Participants will attend three visits, all of which will take place at the Royal North Shore Hospital. The three visits will be separated by at least 48 hours.
Visit 1 will take approximately 2 hours and will take place at the Department of Respiratory Medicine. Participants will complete a questionnaire to quantify their asthma/COPD symptoms and control, and will perform a series of simple breathing tests administered by a trained respiratory scientist:
o Spirometry: This test is to determin
Participants will attend three visits, all of which will take place at the Royal North Shore Hospital. The three visits will be separated by at least 48 hours. Visit 1 will take approximately 2 hours and will take place at the Department of Respiratory Medicine. Participants will complete a questionnaire to quantify their asthma/COPD symptoms and control, and will perform a series of simple breathing tests administered by a trained respiratory scientist: o Spirometry: This test is to determine how quickly your lungs can breathe air in and squeeze air out. You will need to suck and blow air as fast as you can and as forcefully as you can. o Body plethysmography: This test is used to calculate how big your lungs are. This test will involve sitting inside a glass box and taking panting breaths following by very big breaths. o Lung diffusing capacity: This test measures how well the air that you breathe is transported into your blood. We will also ask you take a big, quick breath of air containing a very small amount of carbon monoxide and a very small amount of nitrogen oxide. We will ask you to hold your breath for 10 seconds and then gently breathe all the air out of your lungs. o Forced oscillation technique (FOT): This test measures the stiffness of the airways. This machine sends different sound waves through the air, making the air feel ‘wobbly’. This test involves sitting and breathing normally on a mouthpiece. o Multiple breath nitrogen washout test (MBNW): This test measure how evenly the air is distributed throughout your lungs. You will breathe into a mouthpiece, keeping the size of your breaths within a set range. During the test you will first breathe normal room air and then 100% oxygen for approximately 20 breaths. You will be asked to do this three times. o Bronchodilator test: This is to see how well your lungs respond to an inhaled bronchodilator, which is a medication that relaxes the muscle around the airways and is increase the amount of airway you can breathe out. To determine whether your airways opened up after the bronchodilator, we will ask you to repeat the spirometry and FOT tests in the same way that you performed them earlier. We will administer a total of 4 puffs of salbutamol 100mcg per puff (400mcg in total). o Methacholine challenge test: This is to test your airway sensitivity and involves inhalation of a stimulant (methacholine) that will result in airway narrowing, which closely controlled using lung testing (spirometry). Therefore, you may experience your usual symptoms of asthma or COPD. These symptoms are promptly reversed by inhalation of your usual reliever medication. We will also perform an allergy test called a skin prick test. A small droplet of allergen will be placed on the subject's forearm and the skin will be pricked lightly through the droplet. If subject is allergic to any of the allergens you will develop a small itchy lump, like a mosquito bite. In addition, after these tests we will take a standard blood sample at the Pathology Department, this will be done by a trained nurse. This test allows us to count inflammatory cells and measure inflammatory markers. Visit 2 will take approximately 3 hours and will take place at the Department of Nuclear Medicine. During this visit you will have 2 SPECT scans to look at how the air moves within the lung. This involves breathing in a small amount of a radioactive aerosol, following by lying on a table for about 15 minutes during which the scan is undertaken. We will do 1 scan before, and 1 scan after inhalation of reliever medication (e.g. salbutamol) to see whether your ventilation has approved upon inhalation of your reliever medication. You will also undergo a low-dose CT scan of the chest, which takes about 2 minutes to perform. These two tests will be done by a trained nuclear medicine scientist. In addition, you will perform some of the same breathing tests as visit 1 (FOT and spirometry). These tests will be done by a trained respiratory scientist and will take place at the Department of Nuclear Medicine. Visit 3 (final visit) will take approximately 1.5 hours and will take place at the Department of Nuclear Medicine. During this visit you will be given a methacholine challenge, followed by a SPECT scan, as described above to see how it affects your ventilation. In addition, you will perform some of the same breathing tests as visit 1 (FOT and spirometry).
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Willing and able to give written informed consent 2. Have a physician-diagnosed COPD or asthma 3. For asthma only: - no history of smoking or smoking history of less that 10 pack years 4. For COPD only: - history of current or past smoking, with total exposure of greater than 10 pack years. - FEV1/FVC ratio of less the 95th percentile of the normal range (according to subject age, gender and height); AND - FEV1 less the 95th percentile of the normal range predicted for subject age, gender and height; or FEV1 within the normal range, in the presence of symptoms consistent with COPD; AND - FEV1 greater than or equal to 40% of the predicted value.
Exclusion criteria
1. Significant cardiac disease (ischemic heart disease or arrhythmia) deemed by the investigators or the subject’s treating cardiologist to make it unsafe for the subject to undertake a supervised near-maximal exercise test. 2. Documented hypersensitivity to, or intolerance of anti-cholinergic therapies. 3. Significant respiratory infection or documented exacerbation of Asthma or COPD within the previous 6 weeks. 4. Intensive Care Unit admission in the last 12 months. 5. Other active or chronic respiratory pathologies (for example, interstitial lung disease, asthma, chest wall pathology causing ventilatory restriction). 6. Past history of lung surgery (including lobectomy or pneumonectomy, but not lung biopsy) or thoracic radiation therapy (excluding isolated mediastinal radiation therapy with no evidence of subsequent pulmonary fibrosis). 7. Any major comorbidities deemed to impact on respiratory physiology or symptoms, including severe on uncontrolled heart failure, morbid obesity (BMI >40), muscular or neurological disorders causing respiratory muscle weakness or dysfunctional swallowing. 8. History of chronic kidney disease (creatine greater than the upper limit of normal). 9. Unable to perform lung function testing. 10. Dependence on domiciliary supplemental oxygen, unable to go without for at least 1 hour. 11. Women who are breast feeding, pregnant, or unwilling to avoid pregnancy during the study period. 12. Unable to provide informed consent 13. Current enrolment in other trials
Outcome results
None listed