Novel Endpoints in Cough Challenge Testing

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Mar 27, 2012

Keywords

ClinConnect Summary

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Gender

ALL

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.