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PROCEDURE DETAILS
The following procedures will be performed for ALL participants, at various study visits.
Questionnaires
You will complete questionnaires about your use of electronic nicotine delivery systems (ENDS), e-cigarettes, and traditional cigarettes, as well as any respiratory symptoms you may be experiencing. These questionnaires will assist us in monitoring changes in your product usage over time and assessing the severity of your symptoms.
Pulmonary Function Test
You will undergo a Pulmonary Function Test, which involves breathing into a tube to assess how well your lungs work. The test will measure blockages in your air passages, lung volumes, and your lung's ability to transfer oxygen to the blood.
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Spirometry, Lung Volumes, & Diffusion Capacity
This test will require you to breathe in and out forcefully into a small tube. This test measures the extent of obstruction in your air passages, the lung volumes, and your lung’s ability to transfer oxygen to the blood. On each day of testing the test will be repeated at least three times to make sure an accurate result is obtained.
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Oscillometry
This is a simple way for the doctor to measure your lung function. Oscillometry uses sound waves to measure if the airways are blocked at all because of asthma or other conditions that affect breathing.
Cardiopulmonary Exercise Test
You will undergo a Cardiopulmonary Exercise Test (CPET). This test will be performed on a cycle ergometer, or stationary bike. First, you will rest for 3 minutes, then pedal for 1 minute without any added weight on the bike to warm up. After that, the resistance will slowly increase, and you will pedal faster until you can't continue.
Blood Sample Collection
A blood sample will be collected for analysis. Approximately 3 teaspoons (15mL) of blood will be collected.
Pulmonary MRI
You will undergo a Magnetic Resonance Imaging (MRI) scan. You will fill out a screening questionnaire to make sure that there are no reasons why you should not undergo an MRI. Once completed, you will lie on a table with a special vest around your chest. The table will pass into a large doughnut shaped machine and you will be asked to breathe in xenon gas through a straw and hold your breath. Xenon is a clear, colorless and odourless gas found naturally in air that can be used to get a better picture of your lungs.
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*This procedure is optional for adult participants and only available at certain sites.
ADULT-ONLY PROCEDURES
The following procedures will be performed for adult participants only, at various study visits.
Chest CT Scan
You will have a CT scan as part of the study. A CT scanner looks like a large donut with a narrow table in the middle. While you are laying on the table, the table will slowly move through the “donut-hole” taking pictures of your chest.
Optional: Bronchoscopy
A bronchoscopy is a procedure that allows a qualified doctor to look at your airway through a thin viewing instrument called a bronchoscope. This is done under conscious sedation (you will be given drugs through your vein under observation that will make you drowsy, comfortable and breathing on your own). Once you are under conscious sedation, a long, thin, lighted tube will be inserted into your lungs through your mouth. Your doctor will look at your vocal cords and airways through the bronchoscope (which has a light and a small camera). A bronchoalveolar lavage (BAL) will also be performed while the bronchoscope is inserted. This procedure is done to collect a sample of your lung tissue.
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*This procedure is only available at certain sites.
ADOLESCENT-ONLY PROCEDURES
The following procedures will be performed for adolescent participants only, at various study visits.
Multiple Breath Washout
Multiple breath washout (MBW) is a procedure that uses a machine to assess lung function by measuring how well gases mix inside the lungs. You will breathe through a mouthpiece into the MBW device while wearing a nose clip. If you breathe through a mouthpiece, you will need to keep a tight seal around the mouthpiece so air does not leak out. Each test typically takes 3-10 minutes and will be repeated between 2 and 6 times.
Induced Sputum Sample Collection
You will inhale a salty mist to loosen up some secretions from the chest so that you can cough them up into a container to help detect causes of respiratory tract infections and other diseases of the lungs and airways