Chronic cough Respiratory
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females 18-80 years, inclusive 2. Non-smokers >6 months; ex-smokers <20 pack years Healthy Volunteers 3. No clinically relevant abnormalities based on the medical history, physical examination, vital signs 4. No history of current or significant past respiratory disease, specifically a diagnosis of asthma 5. Spirometry within normal limits Chronic Cough Patients 6. Have a refractory chronic cough as defined by BTS guidelines 7. No evidence of asthma
Exclusion criteria
Exclusion criteria: 1. Routine contraindications to fMRI scanning e.g. certain metal implants, recent surgery, extreme claustrophobia etc 2. Any condition that may increase airway/circulating levels of ATP/adenosine e.g. chronic cardiac failure, chronic hypoxia, vigorous exercise within 48 hours 3. Pregnant or breastfeeding 4. Upper or lower respiratory tract infection or significant change in pulmonary status within 4 weeks of enrolment 5. Any therapy that may modulate cough (e.g. ACE inhibitors, opioids, gabapentin). Patients can be included if they are willing/able to discontinue these for the study duration and a suitable washout period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain connectivity assessed using an fMRI scan at the final visit | — |
Secondary
| Measure | Time frame |
|---|---|
| All outcomes are only measured once (baseline): 1. Cough frequency, recorded by an ambulatory cough monitor 2. Cough reflex sensitivity, as determined by a cough challenge 3. The impact of cough on daily life and activities, measured using the Cough Quality of Life Questionnaire (CQLQ) 4. Depression, measured using The Centre for Epidemiological Studies depression scale (CED-S) 5. Interoception, measured using The Multidimensional Assessment of Interceptive Awareness (MAIA) | — |
Countries
England, United Kingdom