A study investigating Autonomic Dysfunction In chronic cough patienTs

Not Applicable

Completed

• Conditions: Chronic cough; Signs and Symptoms; Cough

• Registration Number: ISRCTN59223220
• Lead Sponsor: niversity Hospital of South Manchester NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-23
• Study Completion: 2014-04-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Chronic cough subjects aged 18 and over or healthy volunteers aged 45 and over
2. Subject must be able to give informed consent
3. Normal spirometry
4. Cough subject only: chronic cough, defined as a cough lasting longer than 8 weeks despite investigation and/or treatment trials for cough variant asthma, post-nasal drip and gastro-oesophageal reflux disease
5. No significant respiratory diseases (except chronic cough in the patient group)
6. No known autonomic function disorders, neuropathy or neurological disorders
7. No history of syncope which is not related to cough
8. Current alcohol consumption exceeding government guidelines

Exclusion Criteria

1. Asthma, diabetes; cardiovascular disease, hypertension, irritable bowel syndrome (IBS), previous brain injury, history of myocardial infarction or any other disorder deemed unsuitable by the investigator
2. Current smoker or ex smoker (more than 10 pack years) and those still smoking within 6 months of the start of the study
3. Regular intense exercise, i.e. competitive sports
4. Blood pressure over 160/90 or abnormal ECG as determined by a medical doctor on screening
5. Pregnancy or breast-feeding
6. Use of angiotensin-converting-enzyme (ACE) inhibitors
7. Use of centrally acting medications that may affect the cough reflex (pregabalin and opiates may not be taken within 1 week of screening and throughout study)
8. History of drug or alcohol abuse
9. Current, treated depression
10. BMI greater than or equal to 32
11. Subjects taking anti-hypertensives; beta blockers; calcium channel blockers; anticholinergic medications or antidepressant treatment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in heart rate variability in response to the Valsalva manoeuvre between the chronic cough group and the healthy control group.

Secondary Outcome Measures

Name	Time	Method
<br> 1. To compare the heart rate variability response to autonomic function testing between chronic cough and healthy subjects<br> 2. To compare the blood pressure response to autonomic function testing between chronic cough and healthy subjects<br> 3. To compare the scores of the Survey of Autonomic Symptom between chronic cough and healthy subjects<br><br> We will be performing beat-to-beat blood pressure analysis on subjects whilst performing deep metronomic breathing, tilt table testing, cold pressor test, voluntary cough and capsaicin-induced cough. We will be comparing the blood pressure and heart rate responses between cases and controls. This is not a longitudinal study and therefore these measurements will be made on one occasion and not repeated at time points.<br>