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Contact Information:

Dr Timothy Harrison
+44 (0)115 831610
tim.harrison@nottingham.ac.uk


Dr Timothy Harrison
+44 (0)115 831610
relief@nottingham.ac.uk


Dr Timothy Harrison
+44 (0)115 831610
tim.harrison@nottingham.ac.uk


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Be Part of Research - Trial Details - A new relief inhaler for mild asthma
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A new relief inhaler for mild asthma

Recruiting

Open to: All Genders

Age: Adult

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Medical Conditions

Mild asthma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


About 10% of UK adults have asthma. Many have “mild” asthma, requiring reliever (blue) inhalers for symptoms with or without low-dose-inhaled steroid preventer (brown) treatment. Asthma causes airway inflammation, so treatment with regular inhaled steroids is important. Blue inhalers provide symptom relief but do not help with inflammation. Increasing reliever inhaler use and decreasing the use of preventer inhalers are associated with poorer asthma outcomes.
This trial aims to replace the first-choice standard blue inhaler for all asthma patients, recommending instead a combination inhaler containing both a reliever and a preventer medication. Patients get preventer medication every time they use their reliever reducing the problem of low preventer use, providing more when asthma control is getting worse. Combination inhalers used for symptom relief are better than blue inhalers at preventing poor outcomes in patients with moderate/severe asthma. This approach has also shown benefits in "mild" asthma, but more evidence is required. This study will compare “standard care” treatment for “mild asthma” versus “new combined inhaler” + inhaled steroid treatment.
The study aims to determine:
1. The effectiveness of a combination inhaler versus standard care for symptom relief in mild asthma
2. The overall costs and savings of the two approaches
3. Healthcare providers' and patients' perspectives of the new approach

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jul 2023 31 Dec 2024

Patients will be allocated either combination inhaled steroid/formoterol or salbutamol when required for asthma symptom relief. Patients continue to use low-dose inhaled steroids. The main measure to be compared between the two treatments will be the time to the first asthma attack after starting treatment. Patients will be in the study for 12 months, completing questionnaires about asthma and health resource use at several time points. A proportion will also be interviewed.


About 10% of UK adults have asthma. Many have “mild” asthma, requiring reliever (blue) inhalers for symptoms with or without low-dose-inhaled steroid preventer (brown) treatment. Asthma causes airway inflammation, so treatment with regular inhaled steroids is important. Blue inhalers provide symptom relief but do not help with inflammation. Increasing reliever inhaler use and decreasing the use of preventer inhalers are associated with poorer asthma outcomes.
This trial aims to replace the first-choice standard blue inhaler for all asthma patients, recommending instead a combination inhaler containing both a reliever and a preventer medication. Patients get preventer medication every time they use their reliever reducing the problem of low preventer use, providing more when asthma control is getting worse. Combination inhalers used for symptom relief are better than blue inhalers at preventing poor outcomes in patients with moderate/severe asthma. This approach has also shown benefits in "mild" asthma, but more evidence is required. This study will compare “standard care” treatment for “mild asthma” versus “new combined inhaler” + inhaled steroid treatment.
The study aims to determine:
1. The effectiveness of a combination inhaler versus standard care for symptom relief in mild asthma
2. The overall costs and savings of the two approaches
3. Healthcare providers' and patients' perspectives of the new approach

Who can participate?
Patients aged 18 years and over with mild asthma prescribed low-dose inhaled steroids from primary care centres across the UK, with particular focus on areas where blue inhaler overuse and asthma attacks are higher.

What does the study involve?
Patients will be allocated either combination inhaled steroid/formoterol or salbutamol when required for asthma symptom relief. Patients continue to use low-dose inhaled steroids. The main measure to be compared between the two treatments will be the time to the first asthma attack after starting treatment. Patients will be in the study for 12 months, completing questionnaires about asthma and health resource use at several time points. A proportion will also be interviewed.

What are the possible benefits and risks of participating?
This study is comparing two standards of care that are already widely in use across the UK for asthma. The combined inhaler (intervention arm) is routinely used in the treatment of moderate /severe asthma with minimal risks involved. The use of a combined inhaler for symptom relief in "mild" asthma is not yet licenced in the UK. However, the researchers do not expect there to be any additional risks or disadvantages to taking part in the study. The researchers do not know if taking part in the study will directly benefit participants but they hope that the information obtained from this study will help them to understand more about the best way to treat mild asthma. The researchers also hope that the participants gain a better understanding of their asthma and how to control it, and that by being in the study they may be able to avoid having more severe asthma attacks.

Where is the study run from?
Nottingham Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
April 2022 to November 2025

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

You can take part if:



You may not be able to take part if:


1. Salbutamol used only to prevent exercise-induced asthma2. Other respiratory or non-respiratory diagnosis which will affect the trial interpretation in the view of the investigator (this includes, but is not limited to, smoking-related chronic obstructive pulmonary disease [COPD] and clinically significant bronchiectasis)3. Participants who are pregnant or who are intending to become pregnant


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Dr Timothy Harrison
+44 (0)115 831610
tim.harrison@nottingham.ac.uk


Dr Timothy Harrison
+44 (0)115 831610
tim.harrison@nottingham.ac.uk


Dr Timothy Harrison
+44 (0)115 831610
relief@nottingham.ac.uk



The study is sponsored by University of Nottingham; Nottingham Clinical Trials Unit and funded by National Institute for Health and Care Research.



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What will you do next?
Read full details for Trial ID: ISRCTN29579666

Or CPMS 54357

Last updated 27 September 2024

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