QIMR Berghofer scientists are leading a clinical trial for a new asthma treatment. Mild asthmatics and people who had asthma when young, but no longer suffer from the condition, are invited to participate. All participants need to be generally healthy, a non-smoker and aged between 18-65 years.
If you are interested in participating in this trial, read all of the information below and email email@example.com or free call 1800 257 179.
What causes asthma?
Asthma symptoms occur when a person’s airways become inflamed. This inflammation is often triggered by exposure to stimuli such as dust, pollen and animals. However, not all individuals exposed to the same trigger develop asthma symptoms. The main reason for this is that some individuals are genetically more likely to develop asthma than others, but we know very little about how genes act to cause asthma.
Why do we need new treatments for asthma?
Asthma affects 2 million Australians; 400,000 in Queensland alone. About 30 % of asthmatics have poorly controlled symptoms, either because they do not comply or do not respond to current treatments. This leads to about 35,000 hospital admissions and 400 deaths per year because of asthma. Therefore, efficient and convenient new treatments for poorly controlled asthma are needed.
What is the purpose of this clinical trial?
Previous research has shown that the interleukin-6 receptor (IL-6R) gene is an asthma risk gene. The IL-6R gene has a more active, and a less active version; the more active version contributes to inflammation in the lungs. There is a medication available, called tocilizumab, which blocks the IL-6R gene. Tocilizumab is currently approved for use in Australia to treat rheumatoid arthritis, an inflammatory disease that shares some features with asthma. We would like to test if it can also be used to treat asthma.
Who will be studied in this project?
We are inviting mild asthmatics and people who had asthma when young, but no longer suffer from the condition, to participate. Mild asthmatics are people who only require reliever medication (such as Ventolin, Asmol and Bricanyl) to manage their asthma symptoms. All participants need to be generally healthy, a non-smoker and aged between 18-65 years.
What will I have to do to participate?
To test if tocilizumab works for asthma you will undergo an allergen challenge. In this test we first identify if an environmental substance, such as dust, triggers your allergies. We will then ask for you to breathe in a weak dose of this allergen, which will increase the inflammation in your lungs. You will be monitored throughout the test. If tocilizumab works in asthma, we expect participants to have milder inflammation and better lung function during this test. We will also invite you to undergo a physical examination, ECG, chest x-ray, lung function and airway sensitivity tests, as well as allergy assessments as part of the trial. We will also collect blood samples and ask some questions about your history of asthma.
How long will it take?
This study includes ten clinical appointments scheduled across six weeks, and is divided into two parts:
- Part one: This part lasts two weeks, and we will conduct tests to confirm you are eligible to be treated with tocilizumab, or a placebo. Three of these appointments are short, lasting two hours, whilst one appointment is long, lasting eight hours.
- Part two: If you are deemed eligible, you will then participate in part two. This part lasts four weeks, during which you will be treated with tocilizumab, or a placebo. You will be required to attend six appointments, five of these will be short (two hours), and one long (eight hours).
Where is the study taking place?
This study has two sites. You will attend all clinical visits at either the Princess Alexandra Hospital in Woolloongabba, or Q-Pharm Pty Ltd, located at the Royal Brisbane and Women’s Hospital campus in Herston, Brisbane.
Is my participation in the project compulsory?
No. Participation is entirely voluntary and requires your consent. Furthermore, you may withdraw from the study and have all the information you provided destroyed at any time.
Will I be compensated?
Yes. You will be compensated for your time as well as travel costs. For long visits we will also provide meals for participants.
Will confidentiality and privacy be assured throughout the study?
Yes. All study data will remain strictly confidential in accordance with the National Health and Medical Research Council (NHMRC) guidelines, and will be stored in password-protected databases with restricted access at QIMR Berghofer. All analyses are conducted and results published in a form that does not allow identification of any individual. Throughout the study privacy of participants will be protected at all times.
Is this study approved by an Ethics committee?
Yes. This study has been approved by QIMR Berghofer and Metro South Human Research Ethics Committees.
Who do I talk to if I still have questions, or if there are other issues that concern me?
If you want further information about the study, please do not hesitate to contact Dr Manuel Ferreira on (07) 3845 3552.
How do I participate?
If you are interested in participating in this clinical trial, please provide your contact details. We will then contact you to provide you with further information about this trial, confirm your interest and schedule a time for a clinical assessment. If you have any questions, email us at firstname.lastname@example.org or call us on 1800 257 179.