Mild/moderate asthma and healthy volunteers Respiratory
Conditions
Interventions
Patients with mild/moderate controlled asthma and healthy individuals will be included as reference (control) groups and will undergo the same baseline visit as patients with severe asthma. Data from
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Mild/moderate asthma controls 1. Adult (=18 years old) 2. Diagnosed with mild/moderate controlled asthma: 2.1 Low/medium dose of ICS/LABA +/- LTRA 2.2 ACQ < 1.5 2.3 Markers of T2 inflammation (B-eos = 0.15 actual or = 0.30 the last year or Sputum eos = 3%, FeNO = 25, allergens positivity) 2.4 Markers of T2 low inflammation (B-eos < 0.15 actual or < 0.30 the last year of sputum eos < 3%, FeNO < 25, allergens negativity) 2.5 No exacerbations in the past 12 months 2.6 No need for prednisolone treatment 2.7 Not a direct candidate for biologic therapy 3. Be able to give valid written consent, and compliant with study procedures and study visits. Healthy controls 1. Adult (=18 years old) 2. Healthy: 2.1 No current medication/therapy for autoimmune, inflammatory, or allergic diseases 2.2 No history of asthma or respiratory symptoms 2.3 No history of allergies 2.4 No upper or lower respiratory infections in the past 4 weeks 3. Be able to give valid written consent, compliant with study procedures and study visits
Exclusion criteria
Exclusion criteria: Mild/moderate asthma controls 1. Unable to understand written information due to language barriers. 2. Unable to give informed consent, i.e., patients who are incapable. 3. Unable to complete study visits. Healthy controls 1. Unable to understand written information due to language barriers. 2. Unable to give informed consent, i.e., patients who are incapable. 3. Unable to complete study visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adequacy of asthma control and change in asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5) <1.5, assessed at 1 year 2. Pulmonary function measured using post-bronchodilator (post-BD) Forced Expiratory Volume in 1 Second (FEV1) percent predicted, at 1 year 3. Exacerbations history, assessed using medical history at 1 year 4. Oral corticosteroids use, assessed using medical history and current medications at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported outcomes (* indicates only in mild/moderate asthma controls): 1.1. Adequacy of asthma control and change in asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5), assessed at visit 1 (week 0).* 1.2. Physical and emotional impact of asthma measured using Asthma Quality of Life Questionnaire (AQLQ), assessed at visit 1 (week 0).* 1.3. Health-related quality of life measured using the EQ5D5L health status questionnaire, assessed at visit 1 (week 0). 1.4. Effect of health problems on the ability to work and perform regular activities measured using the Work Productivity and Activity Impairment General Health (WPAI:GH) questionnaire, assessed visit 1 (week 0).* 1.5. Quality of life and symptom control in allergic rhinitis measured using the Sino-Nasal Outcome Test-22 Questionnaire (SNOT22), assessed visit 1 (week 0).* 1.6. Symptoms associated with dysfunctional breathing patterns measured using the Nijmegen Questionnaire (NQ), assessed during visit 1 (week 0).* 1.7. Subjective measure of sleepiness measured using the Epworth Sleepiness Scale (ESS), assessed visit 1 (week 0). 1.8. Symptoms of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS), assessed visit 1 (week 0). 1.9. Level of fatigue during daily activities measured using the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale, assessed at visit 1 (week 0).* 1.10. Cognition measured using the Cognitive Failures Questionnaire, Screen for Cognitive Impairment in Psychiatry (SCIP), Trail Making test (TMT) part B (specific sites), assessed at visit 1 (week 0). 1.11. Treatment effectiveness measured using the Visual analogue scale (VAS) scale 3TR question (patient and physician perceived), assessed at visit 1 (week 0).* 1.12 Symptoms measured using Symptoms VAS at visit 1 (week 0).* 2. Lung function measured using: 2.1. Pre and post-BD spirometry, assessed at visit 1 (week 0). 2.2. Fractional Exhaled Nitric Oxide (Fe | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactBonnie Millar
Outcome results
None listed