Chronic cough Respiratory
Conditions
Interventions
Current interventions as of 14/04/2021:
Participants will undergo safety screening, including the recording of medical history
measurement of blood pressure, heart-rate and oxygen saturation
and lung function testing (spirometry). Blood samples will be taken, and the subject will be fitted with a 24-h ambulatory cough monitor. The monitor will record all sounds made by the subject for a f
Sponsors
Manchester University Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Chronic cough patients: 1. Aged 18-80 years 2. Have idiopathic chronic cough as defined by BTS guidelines. 3. Non-smokers or ex-smokers with =10 pack years of smoking and >6 months abstinence 4. No clinically relevant abnormalities based on the medical history, physical examination, vital signs or significant past respiratory disease, except for chronic cough Healthy volunteers: 5. Aged 45-80 years 6. Spirometry within normal limits 7. Non-smokers or ex-smokers with =10 pack years of smoking and >6 months abstinence 8. No clinically relevant abnormalities based on the medical history, physical examination, vital signs or significant past respiratory disease
Exclusion criteria
Exclusion criteria: 1. Have received any medications likely to modulate cough within 2 weeks of enrolment. They can be included if willing/able to discontinue these for the duration of the study. 2. Currently taking ACE inhibitors 3. Any condition that may increase circulating levels of ATP/ATP metabolites e.g. chronic cardiac failure, chronic hypoxia, vigorous exercise in the last 48 h, or regular vigorous exercise, such as professional sports or competitive training 4. Pregnant or breastfeeding 5. FEV1/FVC <70% 6. Recent history of upper or lower respiratory tract infection or significant change in pulmonary status within 4 weeks of enrolment 7. Other severe, acute, or chronic medical or psychiatric condition that may increase the risk associated with trial participation or may interfere with the interpretation of trial results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of ATP in bronchial lavage fluid (BALF) measured using validated ATP assays at visit 1 and visit 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/04/2021: 1. Level of adenosine in plasma taken at visit 2 2. Subjective cough severity assessed using cough-related quality of life measured by the Leicester Cough Questionnaire at visit 1 3. Receptors present on airway nerves assessed using staining of nerve cells in bronchial biopsies taken at visit 2 4. Ability of participants with chronic cough to perform PeXA device breathing manoeuvres and if ATP can be measured from exhaled particles 5. To establish if the fungal mycobiome differs between chronic cough patients and healthy volunteers, as a potential source of ATP ______ Previous secondary outcome measures as of 14/02/2020: 1. Level of adenosine in plasma taken at visit 2 2. Subjective cough severity assessed using cough-related quality of life measured by the Leicester Cough Questionnaire at visit 1 3. Receptors present on airway nerves assessed using staining of nerve cells in bronchial biopsies taken at visit 2 _____ Previous secondary outcome measures: 1. Level of adenosine in plasma taken at visit 2 2. Level of inosine in plasma taken at visit 2 3. Level of adenosine in BALF taken at visit 2 4. Level of inosine in BALF taken at visit 2 5. Objective cough frequency measured using an ambulatory cough monitor over a 24-h period 6. Subjective cough severity assessed using cough-related quality of life measured by the Leicester Cough Questionnaire at visit 1 7. Receptors present on airway nerves assessed using staining of nerve cells in bronchial biopsies taken at visit 2 | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Wingfield Digby
Outcome results
None listed