Chronic CoughNCT06376448
An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough
An observational study of Chronic Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cough
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2022to 10 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be identified from those attending the chronic cough clinic or patients that have a history of chronic cough who have previously shown an interest in research.
Who may be able to join
- Male and female patients > 18yrs of age
- Patients with a current cough of at least 8 weeks duration
- Patients with a clear chest X-Ray within previous 2 yrs
- Non- smoker
- Able to understand and comply with the requirements of the study and sign Informed Consent forms.
- Good understanding of written and spoken English -
Who cannot join
- Recent respiratory tract infection (<4 weeks prior).
- Current smokers or ex-smokers with <6 months' abstinence prior to Study.
- Any clinically significant or unstable medical or psychiatric condition that would, in the opinion of the investigator, interfere with the subject's ability to participate in the study safely.
- Participation in any clinical research study evaluating an investigational drug or therapy within 30 days or within 5 half-lives (whichever is longer) of the investigational drug prior to Study visit. If the subject was in an observational clinical study no washout is required.
- Subjects who, in the opinion of the Investigator, should not participate in the study for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Redspiratory Medicine, First Floor, Daisy Building, Castle Hill Hospital
Cottingham, East Yorkshiure, HU16 5JQ
Caroline Wright, 01482624067, c.wright@hull.ac.uk
Rachel H Thompson, Bsc, 01482 461800 ext. Thompson, r.h.thompson@hull.ac.uk
About this study
Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely related to patient-perceived intensity, frequency and most importantly severity. Cough is a symptom and like any other symptom (such as pain) the severity of it can only be gauged by the patient experiencing it.
We have created a one-page brand newl questionnaire that shows 4 distinct cough patterns that we believe exist and an empty field designed so that patients can record a pattern of cough they experience which is not already a choice on the questionnaire. The questionnaire also records patients' experience of how frequent, and intense, the cough is, and how it disrupts their lives, on a 1-10 scale (Visual analogue scale), the sum of these scores is collated and this gives us a severity score. The first phase of the project is to determine whether 30 Chronic cough patients understand the questionnaire, and are able to complete it with little direction, and if the cough patterns we identified encompassed all pattern types. second part of the study is to look at how repeatable the questionnaire is when completed over a 6 week period.
Read the detailed description
STUDY DESIGN This is a single centre observational study.There are two parts to the study. Part 1. Comprises a screening and if suitable the patient will complete the novel questionnaire on one visit.
Part 2. Subjects will be screened, if suitable, patients will be asked to complete the questionnaire and 2-4 weeks later they will be asked to complete the questionnaire once more.
Informed consent and the screening assessment may be conducted either in person at the study site or by telephone, as detailed below.
Informed Consent at Site Potential subjects will be provided with the patient information sheet (PIS) and informed consent form (ICF) at site. A member of the research team will discuss the study with them and take them through the information contained within the PIS and ICF. The subject will be encouraged to ask questions to ensure full understanding. If having read and understood the PIS and ICF the subject wishes to participate, they will sign and date two copies of the ICF, keeping one copy for themselves.
Informed Consent By Telephone
Potential subjects will be sent the PIS and ICF by post or email. Once they have had time to receive and read them, a member of the research team will contact the subject by phone to discuss the study and talk them through the information contained within the PIS and ICF. The subject will be encouraged to ask questions to ensure full understanding. If having read and understood the PIS and ICF the subject gives verbal consent to participate, one of the two following processes will be followed:
- If the full consent discussion has been witnessed at the site, the witness will sign the ICF to confirm that all aspects of the study have been discussed and the subject has freely given verbal informed consent. A copy of the signed ICF will then be sent to the subject.
- If the consent discussion has not been witnessed at the site, the subject will sign and date two copies of the ICF, return one copy to the research team and keep the other copy for themselves.
During screening, eligibility is checked by reference to the selection criteria. If the subject is assessed as eligible for the study, they are assigned a 3-digit subject number. The 3 digit numbers for these patients taking part in part 1, will be prefixed with 1 and those for Part 2, prefixed with a 2.
COUGH PATTERN ASSESSMENTS Part 1. 30 Study participants will be asked to identify their pattern of cough from the patterns identified on the questionnaire, if the patient feels they are unable to identify their pattern then they will be asked to draw a diagram of the pattern and explain the pattern of their cough during the day. This group of patients will be asked to comment on the questionnaire to allow for any improvements. Based on this initial questionnaire completion by this cohort of patients the questionnaire may be updated, especially if new patterns of cough are identified.
Part 2. 30 study participants will be asked to complete the potentially updated questionnaire and then a further copy of the questionnaire will be posted out to these patients for completion 2 to 4 weeks following the first recording on the questionnaire.
Cough frequency/ intensity and disruption Numerical Rating Scale The Cough frequency/ intensity/ and disruption NRS is an 11-point rating scale that patients will be asked to complete.
Each scale is worded as per example below
Now we woud like you to rate how often (frequently) you are coughing , the strength (intensity ) of the cough and overall how disruptive you feel your cough is to your daily life
Please circle most relevant number on scale How often do you cough (Frequency) 0 1 2 3 4 5 6 7 8 9 10 0= no coughing
There are 11 numbered boxes and subjects should select the one that best matches their perception of cough frequency, intensity and disruption to life.
The scores reported on each scale will be summed up to give a total score for severity . This will range from 0-30.
- Conditions
- Chronic Cough
- Medical subject headings
- Chronic Cough
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients
describe % of various cough patterns recorded and gender differnces and any new patterns
Measured: 1 day
Secondary outcomes (3)
measure of cough severity
To sum up the cough frequency, intensity and disruption to daily life VAS scores to give a measure of cough severity
Measured: 1 day
describe any correlation between severity of cough and cough pattern
To compare cough frequency, intensity and disruption to life with pattern of cough, to determine if any correlation.
Measured: 1 day
reproducibility of questionnnare
determine if questionnaire reproducible from repoerting at screening to 4 weeks later
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start24 Oct 2022
- Primary completion4 Oct 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376448
- Sponsor's protocol ID
- cc-obs-01
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough
- ClinicalTrials.gov ID
- NCT06376448
- Acronym / sponsor ID
- cc-obs-01
- Conditions
- Chronic Cough
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 4 Oct 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 19 Apr 2024 (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.
Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely related to patient-perceived intensity, frequency and most importantly severity. Cough is a symptom and like any other symptom (such as pain) the severity of it can only be gauged by the patient experiencing it.
We have created a one-page brand newl questionnaire that shows 4 distinct cough patterns that we believe exist and an empty field designed so that patients can record a pattern of cough they experience which is not already a choice on the questionnaire. The questionnaire also records patients' experience of how frequent, and intense, the cough is, and how it disrupts their lives, on a 1-10 scale (Visual analogue scale), the sum of these scores is collated and this gives us a severity score. The first phase of the project is to determine whether 30 Chronic cough patients understand the questionnaire, and are able to complete it with little direction, and if the cough patterns we identified encompassed all pattern types. second part of the study is to look at how repeatable the questionnaire is when completed over a 6 week period.
Detailed description
STUDY DESIGN This is a single centre observational study.There are two parts to the study. Part 1. Comprises a screening and if suitable the patient will complete the novel questionnaire on one visit.
Part 2. Subjects will be screened, if suitable, patients will be asked to complete the questionnaire and 2-4 weeks later they will be asked to complete the questionnaire once more.
Informed consent and the screening assessment may be conducted either in person at the study site or by telephone, as detailed below.
Informed Consent at Site Potential subjects will be provided with the patient information sheet (PIS) and informed consent form (ICF) at site. A member of the research team will discuss the study with them and take them through the information contained within the PIS and ICF. The subject will be encouraged to ask questions to ensure full understanding. If having read and understood the PIS and ICF the subject wishes to participate, they will sign and date two copies of the ICF, keeping one copy for themselves.
Informed Consent By Telephone
Potential subjects will be sent the PIS and ICF by post or email. Once they have had time to receive and read them, a member of the research team will contact the subject by phone to discuss the study and talk them through the information contained within the PIS and ICF. The subject will be encouraged to ask questions to ensure full understanding. If having read and understood the PIS and ICF the subject gives verbal consent to participate, one of the two following processes will be followed:
- If the full consent discussion has been witnessed at the site, the witness will sign the ICF to confirm that all aspects of the study have been discussed and the subject has freely given verbal informed consent. A copy of the signed ICF will then be sent to the subject.
- If the consent discussion has not been witnessed at the site, the subject will sign and date two copies of the ICF, return one copy to the research team and keep the other copy for themselves.
During screening, eligibility is checked by reference to the selection criteria. If the subject is assessed as eligible for the study, they are assigned a 3-digit subject number. The 3 digit numbers for these patients taking part in part 1, will be prefixed with 1 and those for Part 2, prefixed with a 2.
COUGH PATTERN ASSESSMENTS Part 1. 30 Study participants will be asked to identify their pattern of cough from the patterns identified on the questionnaire, if the patient feels they are unable to identify their pattern then they will be asked to draw a diagram of the pattern and explain the pattern of their cough during the day. This group of patients will be asked to comment on the questionnaire to allow for any improvements. Based on this initial questionnaire completion by this cohort of patients the questionnaire may be updated, especially if new patterns of cough are identified.
Part 2. 30 study participants will be asked to complete the potentially updated questionnaire and then a further copy of the questionnaire will be posted out to these patients for completion 2 to 4 weeks following the first recording on the questionnaire.
Cough frequency/ intensity and disruption Numerical Rating Scale The Cough frequency/ intensity/ and disruption NRS is an 11-point rating scale that patients will be asked to complete.
Each scale is worded as per example below
Now we woud like you to rate how often (frequently) you are coughing , the strength (intensity ) of the cough and overall how disruptive you feel your cough is to your daily life
Please circle most relevant number on scale How often do you cough (Frequency) 0 1 2 3 4 5 6 7 8 9 10 0= no coughing
There are 11 numbered boxes and subjects should select the one that best matches their perception of cough frequency, intensity and disruption to life.
The scores reported on each scale will be summed up to give a total score for severity . This will range from 0-30.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified from those attending the chronic cough clinic or patients that have a history of chronic cough who have previously shown an interest in research.
Key inclusion criteria (6 listed)
- Male and female patients > 18yrs of age
- Patients with a current cough of at least 8 weeks duration
- Patients with a clear chest X-Ray within previous 2 yrs
- Non- smoker
- Able to understand and comply with the requirements of the study and sign Informed Consent forms.
Key exclusion criteria (5 listed)
- Recent respiratory tract infection (<4 weeks prior).
- Current smokers or ex-smokers with <6 months' abstinence prior to Study.
- Any clinically significant or unstable medical or psychiatric condition that would, in the opinion of the investigator, interfere with the subject's ability to participate in the study safely.
- Participation in any clinical research study evaluating an investigational drug or therapy within 30 days or within 5 half-lives (whichever is longer) of the investigational drug prior to Study visit. If the subject was in an observational clinical study no washout is required.
- Subjects who, in the opinion of the Investigator, should not participate in the study for any other reason.
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
The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients
Time frame: 1 day
describe % of various cough patterns recorded and gender differnces and any new patterns
3 secondary outcomes
measure of cough severity
Time frame: 1 day
describe any correlation between severity of cough and cough pattern
Time frame: 1 day
reproducibility of questionnnare
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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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.
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, run by Hull University Teaching Hospitals NHS Trust 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Wright, BSc (01482624067, c.wright@hull.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients (time frame: 1 day). 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 1 Aug 2025.