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

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.

Inclusion criteria

• 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 -

Exclusion criteria

• 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.