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 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT01566968
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects aged 18 and over.
Meet criteria for subject groups as outlined below:
Healthy volunteers:
* Must be non smokers.
* No history of respiratory disease.
Healthy smokers:
* Current smokers with at least 10 pack year history of smoking.
* Spirometry within normal limits i.e. FEV1 \> 80% predicted and FEV1/FVC ratio of \> 75% predicted.
Asthma:
* Physician diagnosis of asthma
* Stable asthma.
* Airway hyperresponsiveness to methacoline; PC20\< 16mg/ml.
* Non smokers or ex-smokers with smoking history of less than 10 pack years.
COPD:
* Physician diagnosis of COPD
* Ex smokers with smoking history of at least 20 pack years
* Spirometry demonstating evidence of airflow obstruction i.e. FEV1/FVC ratio of \< 70%
Chronic cough:
* History of dry cough for at least 8 weeks.
* Normal chest x ray.
* Non smokers or ex smokers of less than 10 pack years history of smoking.
Exclusion Criteria:
* Symptoms of upper respiratory tract infection within the last 4 weeks.
* Participation in another clinical trial of an investigational drug within 4 weeks.
* Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate.
* Patients with severe respiratory disease i.e. FEV1 \< 1.0 litre.
* Use of steroid tablets in previous 2 months or taken more than 3 courses of steroid tablets in the preceding 12 months in subjects with asthma or COPD.
* Change in asthma treatment in the preceding 6 weeks in asthma group
* Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01566968
Study Brief:
Protocol Section:
NCT01566968