Impact of Refractory Chronic Cough on Activities of Daily Living and Response to Acute High-intensity Exercise

Chronic cough is a common and debilitating condition that affects up to 10% of the global population. The health impact of chronic cough is multifaceted and manifests both physical and psychological symptoms including syncope, chest pain, lethargy, depression and anxiety. It is now also recognised that chronic cough often leads to social isolation and may impact an individual's ability or confidence to undertake routine daily tasks / lead an active lifestyle.

The primary aim of this study is therefore to characterise the impact of refractory chronic cough on the ability to undertake daily activities - i.e., determine whether individuals with chronic cough exhibit impaired levels of physical activity during usual daily living when compared with healthy matched controls. A secondary aim is to assess the short-term impact of high-intensity exercise on cough (i.e., determine whether an acute bout of exercise alters cough frequency and/or severity).

Study Overview

• Status: Terminated
• Conditions: Healthy Adult Participants; Chronic Cough (CC)

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9JT
      • University of Leeds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with refractory chronic cough will be recruited from the Hull Cough Clinic, Castle Hill Hospital.

Description

Inclusion Criteria:

• Age >18 years
• Chronic cough as per European Respiratory Society definition (>8 weeks duration)
• High symptom burden (i.e., cough visual analogue scale >40 mm at pre-study screening)
• Chest radiograph or CT within 3 years of the screening visit with no abnormalities considered to contribute to chronic cough

Exclusion Criteria:

• Smokers or individuals who gave up smoking within 12 months
• Smoking history >20 pack-years
• Long-COVID or post-COVID syndrome (defined as symptoms lasting over 12-weeks in duration)
• Recent exacerbation of cough within 4 weeks of inclusion
• Respiratory tract infection within 4 weeks of inclusion

• Currently taking any of the following medications:

  • ACE inhibitors and within 3 months of inclusion
  • Antitussives (opioids, pregabalin, gabapentin, amitriptyline, nortriptyline, or over the-counter medications) within 2 weeks of inclusion
  • Medical treatments for gastro-oesophageal reflux disease (GORD), eosinophilic bronchitis or other cough related conditions, initiated or changed (i.e., not in a stable regimen) for 4 weeks prior to inclusion
• Medical history of asthma or exercise-induced bronchoconstriction (EIB), COPD, or chronic bronchitis in the judgement of the investigator
• Medical conditions/history or other circumstances which, in the judgement of the investigators, could increase the risk of adverse events or bias the study results

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Refractory chronic cough (RCC); Adults with refractory or unexplained chronic cough of ≥8 weeks' duration recruited from a specialist cough clinic.
Healthy controls; Adults without chronic respiratory disease recruited as a healthy comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily step count	Objectively measured using wrist-worn accelerometry over 7 days.	1-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough frequency	Objectively measured using the Leicester Cough Monitor over 24 h	24 h
Post-exercise cough frequency	Objectively measured using the Leicester Cough Monitor for 24 h following a standardised high-intensity exercise challenge	24 h

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: University of Hull; King's College Hospital NHS Trust; Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Physical activity; Cough; Physiology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Chronic Cough; Cough; Motor Activity
• Other Study ID Numbers: 344527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No