NCT06766175

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Dec 2024Dec 2026

Study Start

First participant enrolled

December 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

December 13, 2024

Last Update Submit

January 3, 2025

Conditions

Keywords

CoughPhysical activityExercisePhysiology

Outcome Measures

Primary Outcomes (1)

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

    Physical activity status including: \- Absolute daily steps

    1-week

Study Arms (1)

Chronic cough as per European Respiratory Society definition (>8 weeks duration)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Currently taking any of the following medications:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chronic CoughCoughMotor Activity

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Oliver J Price, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 13, 2024

First Posted

January 9, 2025

Study Start

December 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations