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

ConditionChronic Cough
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHull University Teaching Hospitals NHS Trust

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Time frame
1 day

Secondary outcomes

1

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

Time frame
1 day
2

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.

Time frame
1 day
3

reproducibility of questionnnare

determine if questionnaire reproducible from repoerting at screening to 4 weeks later

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.