Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Imperial College London
With
AstraZeneca
Age
40–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Non-smoking volunteer
aged 40 -75 years (age matched to COPD patients)
Normal spirometry (normal FEV1/FVC ratio \>70% and FEV1\>80% predicted)
Subjects are able to give informed consent
Current and/or ex-smokers with no less than 10 pack-year smoking history
aged 40 -75 years
FEV1 greater than or equal to 30% and less than 80% of predicted (the upper value is a prostbronchodilator value)
FEV1/FVC \< 70%
Patients with stable COPD
Inhaled Corticosteroid (ICS) treatment, if exists, must be stopped for 2 weeks prior the study treatment
Long-acting beta2-agonists and theophylline need to be stopped at least 3 days before run-in , but anti-cholinergics will be allowed throughout the study
The subjects are able to give informed consent
You may not be if
Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
Upper respiratory infection within the last 4 weeks
Subjects who have received research medication within the previous one month
Subjects unable to give informed consent
Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
Evidence of asthma
Bronchodilator reversibility \> 12%
Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
Patients who have had oral steroids within 8 weeks prior to the screening visit.
Patients who are already on ICS and in which it is considered unsafe (as judged by the Investigator) to stop this treatment for the study period.
Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the screening visit.
Upper respiratory infection within the last 4 weeks
Subjects who have received research medication within the previous one month
Subjects unable to give informed consent
Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study
Patients with significant co-morbidities as judged by the investigator
Any other respiratory disease, which is considered by the investigator to be clinically significant
