Characterising neutrophil serine protease activity in type 2 low asthma
Type 2 inflammatory asthma
This is an observational study, which means it will not be testing a new drug or treatment. Instead, the study will carefully study people with asthma to better understand what is happening in their lungs. The study plans to recruit 120 adults with moderate-to-severe asthma from NHS Tayside. Each patient attending the specialist asthma clinic in Ninewells hospital will be asked whether they would like to participate in this study. At this clinic visit, participants will: Provide a sputum (phlegm) sample by coughing into a container. This allows us to measure proteins released by neutrophils, such as neutrophil elastase. Complete breathing tests (such as spirometry and oscillometry) to measure lung function. Answer short questionnaires about their asthma symptoms and quality of life. Provide a small blood sample to measure markers of inflammation. Afterwards, researchers will analyse the samples in the laboratory. The results will be compared between patients with type 2-low asthma and those with type 2-high asthma. The researchers expect to identify a group of patients with high neutrophil activity who may represent a distinct type of asthma.
1. Patients aged ≥18 years old with GINA-defined moderate-to-severe asthma. 2. Taking a medium to high dose of ICS/LABA OR high dose ICS with another second line controller (BDP equivalent dose of ≥800µg) of step 4/5 GINA therapy. 3. Established diagnosis of persistent asthma ≥6 months according to GINA guidelines. 4. Ability to give informed consent. 5. Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s wellbeing. 6. Able to understand the study procedures and the risks involved. 7. Good physical and mental status, determined on the basis of the medical history and a general clinical examination at screening.
1. Patients who are taking biologics for asthma. 2. Patients who are on maintenance oral corticosteroids. 3. Patients who have required a course of oral corticosteroids in the past month. 4. Any other respiratory diseases such as COPD and moderate to severe bronchiectasis which in the opinion of the investigator are clinically significant and may have an impact on the study outcomes. 5. Any disorder that is not stable in the opinion of the Investigator. 6. Patients unable or unwilling to consent. 7. Anyone who has had a recent chest infection or asthma exacerbation (within the past 4 weeks), as this may temporarily alter neutrophil levels in the sputum. 8. People currently taking part in another clinical trial involving investigational medicines or who have received such medicines within the past 3 months. 9. Individuals with severe comorbidities (such as uncontrolled heart disease, active cancer, or significant immunosuppression) where participation may pose additional risk.