An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough

NCT06376448 | Recruiting

• 1 other identifier: cc-obs-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (3)

• measure of cough severity

  1 day

• describe any correlation between severity of cough and cough pattern

  1 day

• reproducibility of questionnnare

  4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Redspiratory Medicine, First Floor, Daisy Building, Castle Hill Hospital

Cottingham, East Yorkshiure, HU16 5JQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Caroline Wright, BSc

CONTACT

01482624067; c.wright@hull.ac.uk

Rachel Thompson

CONTACT

01482624009; r.h.thompson@hull.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: October 24, 2022
• Primary Completion: October 4, 2025
• Study Completion: December 10, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-04

Locations

GB (1)