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NCT Number: NCT06766175

Impact of 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 unexplained 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 age, gender and BMI 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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location status: Recruiting

Location contact

Oliver J Price, PhD

CONTACT

[email protected]

+44(0)113 343 2909

Oliver J Price, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Physical activity status assessed using objective wearable accelerometer (ActiGraph LEAP)

    Time frame: 1-week

    Physical activity status including:

    • Absolute daily steps

Study contacts

Contact information is provided by the study sponsor or research team.

Oliver J Price, PhD

CONTACT

[email protected]

+44(0)113 343 2909

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Hull York Medical School
  • King's College Hospital NHS Trust
  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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