Chronic Cough (CC)NCT06766175
Impact of Refractory Chronic Cough on Activities of Daily Living and Response to Acute High-intensity Exercise
An observational study of Chronic Cough (CC) and Healthy Adult Participants, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Cough (CC), Healthy Adult Participants
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with refractory chronic cough will be recruited from the Hull Cough Clinic, Castle Hill Hospital.
Who may be able to join
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
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).
- Conditions
- Chronic Cough (CC), Healthy Adult Participants
- Keywords
- Cough, Physical activity, Exercise, Physiology
- Medical subject headings
- Chronic Cough, Cough, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Daily step count
Objectively measured using wrist-worn accelerometry over 7 days.
Measured: 1-week
Secondary outcomes (2)
Cough frequency
Objectively measured using the Leicester Cough Monitor over 24 h
Measured: 24 h
Post-exercise cough frequency
Objectively measured using the Leicester Cough Monitor for 24 h following a standardised high-intensity exercise challenge
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: Study terminated early due to cessation of funding support. This was an administrative decision unrelated to safety or study findings. Analysis and publication of findings from the available dataset are planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cough (CC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, University of Hull
- Responsible party
- Principal investigator, Dr Oliver Price, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766175
- Sponsor's protocol ID
- 344527
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Refractory Chronic Cough on Activities of Daily Living and Response to Acute High-intensity Exercise
- ClinicalTrials.gov ID
- NCT06766175
- Acronym / sponsor ID
- 344527
- Conditions
- Chronic Cough (CC), Healthy Adult Participants
- Keywords
- Cough, Physical activity, Exercise, Physiology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated early due to cessation of funding support. This was an administrative decision unrelated to safety or study findings. Analysis and publication of findings from the available dataset are planned.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, University of Hull
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory chronic cough will be recruited from the Hull Cough Clinic, Castle Hill Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily step count
Time frame: 1-week
Objectively measured using wrist-worn accelerometry over 7 days.
2 secondary outcomes
Cough frequency
Time frame: 24 h
Post-exercise cough frequency
Time frame: 24 h
Results and safety
The study was stopped early (reason given: Study terminated early due to cessation of funding support. This was an administrative decision unrelated to safety or study findings. Analysis and publication of findings from the available dataset are planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cough (CC) and Healthy Adult Participants, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated early due to cessation of funding support. This was an administrative decision unrelated to safety or study findings. Analysis and publication of findings from the available dataset are planned.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily step count (time frame: 1-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.