PROCEDURES IN THE 3TR-ABC STUDY
Below, you can find a short description of each of the examinations and procedures
that will be done in the 3TR-ABC study.
Some samples may not be taken at your study site
– ask your local study team if in doubt of what procedures, you will have to participate in.
A urine test checks the different compounds in urine, a waste product made by the kidneys. You can check the color, clarity, odor, concentration and acidity (pH) of your urine. Furthermore, you can check the levels of protein, sugar, blood cells, or other substances in your urine. Urine test can give information about health. The kidneys take out waste material, minerals, fluids and other substances from the blood to be passed in the urine. Urine has hundreds of different body wastes. What you eat and drink, how much you exercise and how well your kidneys work can affect what is in your urine. More than 100 different tests can be done on urine.
In this study, a total amount of around 2 times 80 mL urine is collected at the beginning and the end of the visit in this research study. You collect the sample in the container provided by the health care professional and collect “mid-stream” urine. A “mid-stream” sample means you don’t collect the first and the last part of urine that comes out.
You do not need to drink extra fluids before giving the sample: Normal intake is sufficient for collecting the correct material. If larger volumes of urines are produced due to excessive drinking the analytes of interest may not be seen in the test.
There are no risks when giving a urine sample. It is a routine procedure in general diagnostics.
You will be asked to answer different questionnaires that are all relevant to asthma and your general health.
Cognitive testing is a neuropsychological evaluation that gives information about possible difficulties a person may have related to specific brain functions like remembering, focusing, orientation and so on. The test consists of specifically designed tasks that are used to measure a psychological function known to be linked to a particular brain structure or pathway. The test is used for research into brain function and in a clinical setting for the diagnosis of deficits.
Over time some patients with asthma develop cognitive dysfunctions and the prevalence of these symptoms is related to the severity of airflow obstruction. The purpose of the evaluation is to determine the presence, nature, and severity of cognitive dysfunction in asthma patients. It provides a baseline to monitor future changes in cognitive abilities, mood and personality, including treatment effects.
In this study, cognitve functions will be assessed by using different short neuropsychological (maximum 15-minutes each) screening tools. The tests are administered as short interviews to a single person working with an examiner in a quiet environment, free from distractions. The abilities tested include attention, learning, memory and working memory.
Blood can be tested for many different things and thus are taken for many different reasons, for example:
- To help diagnose certain conditions, or to rule them out if symptoms suggest possible conditions.
- To monitor the activity and severity of certain conditions. For example, a blood test may help to see if a condition is responding to treatment.
- To check the body’s functions such as liver or kidney.
The vein used for blood sampling is usually on the inside of your elbow or the back of your wrist. A tight band (tourniquet) is usually placed around your upper arm. This makes the vein fill with blood and makes it easier for the blood sample to be taken. The skin over the vein is cleaned with an antiseptic wipe and the needle is inserted into the vein through the clean skin causing a sharp pricking sensation. The needle is connected either to a syringe, or directly to the blood sample bottles.
The tourniquet is undone and when the required amount of blood is taken, the needle is removed. The small wound is pressed on with cotton wool for a few minutes to stop the bleeding and prevent bruising. A sticking plaster may be put on.
The body copes well with the amount of blood taken (around 78.5 mL, will be taken in this study) and the volume is quickly replaced by the blood production system in the blood marrow. For comparison, about 500 mL of blood are given by blood donors during each donation.
Complications from blood tests are rare, but sometimes a bruise develops where the needle was inserted. As with any wound, an infection may develop. See your doctor if the wound site becomes red and inflamed.
Some people feel faint during a blood test. Tell the health care professional doing the test if you feel faint, as you should immediately lie down to prevent fainting. You may also prefer to lie down while the test is taken, if you have previously experienced becoming unwell when having a blood sample taken.
A fractional exhaled nitric oxide (FeNO) test is a simple test to see how much nitric oxide is in your breath.
Nitric oxide (NO) is found in the atmosphere and is higher in areas with air pollution. It is also produced in the body, especially if there is inflammation.
When you have asthma, your airways may be inflamed. The FeNO test can be useful to help your doctor understand the amount of inflammation in your airways due to asthma, and the measurements can be used to check if the medication you are taking is working.
Smoking before the FeNO test can affect the result, so avoid smoking beforehand if you can. The health care professional will also ask you if you are an active smoker. The measurement takes a few minutes to perform and gives immediate results. There are no severe risks or side effects to performing the FeNO test. You can take your medicine as usual in the morning.
During the FeNO test you breathe into a plastic mouthpiece or a cardboard tube attached to a monitor. The monitor shows the reading on its screen and some monitors will use sound or pictures to guide you during the test. You will breathe deeply, with your mouth open, and then breathe out little by little until your lungs are empty. The breath out normally takes 10 seconds in adults.
You will have to do the measurement 1 to 3 times depending on device. Most people find it easy to do the test. Some people feel a little lightheaded after the FeNO test, but this normally lasts for no more than a few minutes.
Breathomics is the analysis of a patient’s exhaled air for disease indicators. It is relatively new way to examine patients, but the idea that a patient’s breath can aid in the diagnosis of diseases is far from new. In ancient Greece, physicians considered sweet smelling breath an indicator of diabetes or a fishy smell suggesting a liver condition. Modern breathomics is based on the same principle, but it is much more sophisticated and offers a host of diagnostic insights.
Collected exhaled breath samples contain large amount of chemical information. Exhaled air consists mainly of nitrogen, oxygen, argon and water. In addition, there are traces of hundreds and even thousands of so-called volatile organic compounds (VOC). The samples have over the last couple of years gained a lot of research interest in its potential for disease diagnosis.
The collection of exhaled air is non-invasive, painless and without risks or side effects. 2 hours before the test you should not eat or drink, chew gum, exercise or take any medication. If you do so, please tell the health care professional. You can take your medicine as usual in the morning.
To analyze the exhaled breath, the exhaled air is first collected in a plastic bag. You first breath normally 10 times through a mask, then take a deep breath and exhale fully through the mask and the air is collected, when the plastic bag is attached.
Spirometry is the most common of the lung function tests and is a simple breathing test. The test is used to see how well your lungs are working. The test can help diagnose various lung conditions, but it is also used to monitor the severity of different lung conditions and their response to treatment.
Spirometry is the name of the test, whilst a spirometer is the device used to make the measurements. There are various spirometer devices, but they all measure the same thing. They all have a mouthpiece that you use to blow into the device.
The test is performed in following way: first your height and weight are measured. Afterwards you will be asked to breathe into the spirometer. A clip will be put on your nose to make sure that no air escapes from your nose. For the test you will be asked to breathe in fully, seal your lips around the mouthpiece of the spirometer and then you blow out as fast and as far as you can until your lungs are completely empty. This can take several seconds.
The measurements will be repeated a minimum of 3 times to check that the readings are around the same each time you blow into the machine. The test operator will guide you and instruct you along the way. The entire test, including instructions, height and weight measurements and questions about medication, usually takes around 30 minutes.
Performing the test can be physically demanding, and the test will be discontinued if you feel any pain or discomfort along the way.
Spirometry measure the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.
The most common measurements are:
- Forced Expiratory Volume in 1 second (FEV1). This is the amount of air you can blow out within 1 second. With normal lungs and airways, you can normally blow out most of the air from your lungs within 1 second.
- Forced Vital Capacity (FVC). The total amount of air that you can blow out in one breath.
- FEV1 divided by FVC (FEV1/FVC). Of the total amount of air that you can blow out in one breath, this is the proportion that you can blow out in 1 second.
For more information you can read the factsheet from the European Lung Foundation:
https://europeanlung.org/en/information-hub/factsheets/testing-your-lungs-spirometry/
A mannitol challenge test is done to assess the sensitivity (hyperresponsiveness) of the airways. The test involves you to do a spirometry and then inhaling an amount of mannitol (dry powdered sugar) before repeating the spirometry. The procedure will be repeated with increasing doses of mannitol. The mannitol test is positive if the spirometry shows a significant decrease in your lung function. Bronchodilator will always be given to reverse the effects of the mannitol.
Saliva is composed of water, mucus, proteins, mineral salts, and amylase. It contains many important substances including electrolytes, antibacterial compounds, and various enzymes. It also contains DNA and those can give a large amount of information.
Saliva sampling is a simple and easy test with no risks or side effects. We collect the saliva when you spit in a petri dish or the tube provided by the health care professional. The sample is then sent to the lab and analyzed.
The sampling does not affect your daily treatment
A sputum induction test is a simple test which involves producing a fresh sample of sputum so it can be analyzed in a laboratory. Sputum is the mucus produced in the lungs.
The purpose of the test is to analyze your sputum for different cells that are found in your lungs, to see how much inflammation is in your lungs, and of which type. The test is used for both diagnosis and monitoring of disease.
The sputum induction test is a painless procedure. It involves breathing in different concentrations of saline (mild salty water) through a nebulizer and then carrying out cough-like movements to produce a sample of sputum.
Before the test starts, the trained health care professional will ask you some questions. These are to check whether there is medical reason why you should not do the test. The experienced health care professional will explain to you in detail beforehand and will answer any questions you may have.
The full test usually lasts around 30-45 minutes.
There are no known risks associated with this test, and we would not expect you to have any side effects during or after this test. However, when you have asthma you may find it causes a temporary sensation of chest tightness. For this reason, the test is done step by step, with careful monitoring. You will be given reliever medication before the test, to help prevent this sensation. After the test you may feel a little tired. This is normal and you should recover quickly.
If you have any chest pain or other problems, such as dizziness or feeling lightheaded during the test, please tell the healthcare professional.
Feces contain bacteria and other substances that are in the digestive system. Little is known about the bacterial composition in the feces of severe asthma patients. By investigating the bacterial composition from the stools you provide you will greatly contribute to our understanding of this area.
You will receive two stool collection tubes so you can do the sampling at home.
Computed Tomography (CT) is a method of examination that allows diagnosing and monitoring of lung diseases.
Modern CT equipment enables a scan covering the whole lung tissue and allows clinicians to examine the lungs’ structure with greater accuracy.
It is a standard procedure in respiratory medicine.
Bronchoscopy is a procedure that allows doctors to examine your airways. During bronchoscopy, a doctor inserts a thin, bendable tube through the mouth or nose into the lungs. A light and a small camera allow the doctor to look inside the airways. In 3TR-ABC, bronchoscopy is used to obtain samples of tissue from the airway wall, for research purposes.
Risks:
The chance of complications with this procedure is very small. You may experience a sore throat and nose the next day. Some patients have a nosebleed or blood-stained phlegm and some patients with asthma experience a flare up after the procedure. In the largest study currently undertaken, only 1% of over 20,000 patients experienced serious complications. Fever is relatively common after bronchoscopy, but not always sign of infection.
How to prepare:
Preparation for bronchoscopy usually involves food and medication restrictions. You may be asked to stop taking blood-thinning medications several days before bronchoscopy. You will also be asked not to drink or eat (fast) for 8 hours before the procedure.
On the day of procedure, you’ll be asked to put on a gown and take out any dentures, remove hearing aids, contact lenses and glasses. You will need someone to accompany you home, if a sedative is administered during the procedure. You should not plan to drive, operate machinery or drink alcohol for 24 hours after having the sedative.
The entire procedure, including preparation and recovery time, typically takes about 4 hours. The bronchoscopy itself usually lasts about 15 to 30 minutes.
Before, under and after the procedure:
You will lie on your back during the procedure and be connected to monitors so that the health care team can track your heart rate, blood pressure and oxygen level during the procedure. You’ll be given a sedative through a vein (intravenously) to help you relax. You’ll feel sleepy, but you’ll still be awake enough to be breathing on your own. Typically, you will not be able to recall the procedure afterwards, due to the sedative. A numbing medication will be sprayed in your throat. The bronchoscope is advanced slowly, and most people describe the feeling as uncomfortable, rather than painful.
You’ll be monitored for several hours after the bronchoscopy, and your mouth and throat will probably be numb for a couple of hours. You may have a mild sore throat, hoarseness, a cough or muscle aches. This is normal and you can drink and eat as normal afterwards.
Call your doctor right away if you have a fewer that lasts more than 24 hours, have increasing chest pain, have trouble breathing or cough up more than a tablespoon of blood.
For more information you can read the factsheet from the European Lung Foundation:
https://europeanlung.org/en/information-hub/factsheets/bronchoscopy/