Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT00977366
Eligibility Criteria:
Inclusion Criteria:
Healthy volunteers inclusion:
* Over 18 years
* Measurable cough reflex sensitivity - required as is the primary end-point
* No current or past history of chronic cough or chronic respiratory disease
Chronic Cough Patients inclusion:
* Over 18 years
* Chronic persistent cough (\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux
* Normal chest radiograph - primary respiratory cause for cough excluded
* Normal lung function - primary respiratory cause for cough excluded Measurable cough reflex sensitivity - required as primary end-point
Exclusion Criteria:
* Recent upper respiratory tract infection (\<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles
* Pregnancy/breast-feeding - unknown effects of oesophageal acid infusion
* Current smokers or ex-smokers with \< 6 month abstinence or history \> 20 pack years - smoking can alter the sensitivity of the cough reflex
* Opiate or ACE inhibitor use or centrally acting medication - can alter the cough reflex sensitivity
* Symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity
* Significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00977366
Study Brief:
Protocol Section:
NCT00977366