Information for participants
RELIEF Trial Overview for Participants
The trial is looking at whether an inhaler which contains drugs to both relieve symptoms and to prevent attacks, in a single combination inhaler, is better for treating mild asthma symptoms than two separate inhalers -- one for symptoms (attacks) and one for prevention (before attacks happen).
It wants to find out;
• How effective a combination inhaler might be versus standard care for symptom relief in mild asthma
• Overall costs and savings of the two treatments
• Health care providers and patients views on the new way to treat mild asthma.
How much does asthma cost the UK?
Asthma is one of the most prevalent long term conditions in the UK. It costs the UK £1.1billion every year in prescriptions, GP visits, hospital care and benefits.
Who can take part in the study?
Patients aged 18 and over with a clinical diagnosis of mild asthma.
If you are suitable and consent to the trial, what happens next?
Participants will be selected at random to be in either one of two groups for the trial. Both groups will continue to use their brown preventer inhaler, but one group will receive usual care blue reliever inhaler (e.g. Ventolin) and the second group will receive a combination inhaler (e.g. Symbicort or Fostair).
We will ask you in a monthly text if you have had any asthma attacks that needed steroid tablets, such as prednisolone. We also have some questionnaires about your asthma that we will ask you to fill in at different times throughout the trial. The questionnaires will help provide information about how best to understand participants’ experiences and how effective each treatment is. There is also an option for some people to be interviewed about their asthma experiences while in the trial. Your time in the study will be no more than 12 months.
Read the full Participant Information Sheet.
If you are interested in taking part, please contact your local GP to see if they are participating.
My Study Data
What will happen to the information collected about me?
We will need to use information from you for this research project. In doing this we will follow all clinical and research ethical and legal practice. All information about you will be kept strictly confidential and we will keep all information about you safe and secure.
This information will include your name, date of birth (DOB) and contact details. Some of the data collected for the study may be looked at by authorised persons from the Nottingham Clinical Trials Unit (NCTU) at the University of Nottingham who are coordinating the research. They may also be looked at by authorised people from regulatory authorities to check that the study is carried out correctly. All will have a duty of confidentiality to you as a research participant.
People who do not need to know who you are will not be able to see your name or contact details. A copy of your consent form will be sent to the NCTU but any other information about you which leaves the clinic will have your name and address removed (anonymised). Your data will be anonymised with only your initials and DOB and will be identified by a code number instead. No one will be able to identify your involvement when the findings are published at the end of the study. The anonymised information collected about you may be used to support other research in the future and may be shared with other researchers.
Your personal contact details will be available to the Nottingham Clinical Trials Unit (NCTU) so they can contact you during the study and send the questionnaires. Once the study is finished, some of the data will be kept so we can check the results. Your name and email address will be kept after the end of the study so that we can contact you about the findings of the study. If you do not wish to be contacted with the results of the study all your contact details will be disposed of securely (deleted) at the end of the study. All other data (research data) will be kept securely for 7 years. After this time, your data will be disposed of securely.
As an optional addition to the study, you may also agree to have your name and telephone number shared with Esendex, our text messaging provider and their subprocessors, and will be used to send you text message reminders about the study and study questionnaires whilst you are participating in the study. Once your participation has ended you will no longer be contacted but Esendex will retain the data for two years or until the end of the study (whichever occurs first).
What are your choices about how your information is used?
- You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
- If you are pregnant, we will let your GP know that you are taking part in this study and ask them to provide us with information on the outcome of your pregnancy. With your permission, we may use NHS Digital and other central UK NHS bodies to help us obtain your pregnancy outcome.
- If you agree to take part in this study, you may have the option to take part in future research using your data saved from this study.
Where can you find out more about how your information is used?
You can find out more about how we use your information