A New Relief Inhaler for Mild Asthma
Research type
Research Study
Full title
Randomised controlled trial of a new relief inhaler in mild asthma: the RELIEF trial
IRAS ID
1006098
Contact name
Timothy Harrison
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN29579666
Research summary
Approximately 10% of UK adults have asthma. Many have “mild” asthma, requiring reliever (blue) inhalers for symptoms with or without, low-dose-inhaled steroid (preventer) treatment. Asthma causes airway inflammation, so treatment with regular inhaled steroids is important. Blue inhalers provide symptom relief but do not help inflammation. Increasing blue inhaler use & decreasing use of preventer inhalers is associated with poorer asthma outcomes.
The Global Initiative for Asthma (world-wide asthma recommendations) took a bold and controversial step of replacing the first-choice standard blue inhaler for all asthma patients, recommending a combination inhaler containing both 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. We know combination inhalers are better for moderated/severe symptom relief and outcomes, and see some benefit in “mild” asthma, but more evidence is required. This study will compare “standard care” treatment for “mild asthma” versus “new combined inhaler” + ICS treatment.
The study aims to determine;
• Effectiveness of a combination inhaler versus standard care for symptom relief in mild asthma
• Overall costs and savings of the two approaches
• Health care providers and patients perspectives of the new approach
Study to include 2300 volunteers from primary-care centres, with mild asthma, across the UK, with particular focus on areas where blue inhaler overuse and asthma attacks are higher. Patients will be selected at random to be in either one of two groups for the study. Asthma exacerbations is the primary outcome.
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.
Patients with asthma have helped throughout with planning and a patient co-applicant will join TMG.REC name
HSC REC B
REC reference
22/NI/0151
Date of REC Opinion
3 Mar 2023
REC opinion
Further Information Favourable Opinion