NCT06376448 An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough
| NCT ID | NCT06376448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hull University Teaching Hospitals NHS Trust |
| Condition | Chronic Cough |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-10-24 |
| Primary Completion | 2025-10-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-10-24 with a primary completion date of 2025-10-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 1. Male and female patients \> 18yrs of age 2. Patients with a current cough of at least 8 weeks duration 3. Patients with a clear chest X-Ray within previous 2 yrs 4. Non- smoker 5. Able to understand and comply with the requirements of the study and sign Informed Consent forms. 6. Good understanding of written and spoken English - Exclusion Criteria: 1. Recent respiratory tract infection (\<4 weeks prior). 2. Current smokers or ex-smokers with \<6 months' abstinence prior to Study. 3. 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. 4. 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. 5. Subjects who, in the opinion of the Investigator, should not participate in the study for any other reason.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06376448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Cough. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06376448 currently recruiting?
Yes, NCT06376448 is actively recruiting participants. Contact the research team at c.wright@hull.ac.uk for enrollment information.
Where is the NCT06376448 trial being conducted?
This trial is being conducted at Cottingham, United Kingdom.
Who is sponsoring the NCT06376448 clinical trial?
NCT06376448 is sponsored by Hull University Teaching Hospitals NHS Trust. The trial plans to enroll 60 participants.