INSIGHT-AM is a research study looking at a unique aspect of lung immune function. We are studying an inhaled intervention that we believe can improve lung immunity, especially in the settings of ageing and critical illness.

The study includes both healthy volunteers and critically ill patients within hospitals. At different stages we will be looking for participants aged 18-30 and aged 60+. The following are essential requirements for participation:

• You must consider yourself to be in good health, without any risk factors that may cause diseases of the lungs.
• You must not have a history of significant cardiovascular diseases (heart attacks, strokes), diabetes or kidney impairment.
• You must not take regular medications other than the following: skin creams, hormone therapy (oral contraceptives, hormone replacement therapy), blood pressure medications (maximum of one drug for this purpose), drugs for constipation, aspirin, paracetamol, codeine, thyroid replacement, and PPIs for acid reflux (e.g. Omeprazole, Lansoprazole).

There is an initial study week, and an optional follow-up week. Your first visit would be for a brief 20-30 minute review to ensure you are fit to participate. We typically perform this on a Monday, then see you again on 3 consecutive days (Tuesday - Thursday). The visits on Tuesday and Wednesday are also brief (approximately 30 minutes) to administer a dose of an inhaled intervention. The Thursday visit is to have a bronchoscopy. This is a medical procedure in which we examine inside the lungs with a small fibre-optic camera on a flexible telescope passed down the nose or mouth. It is a common and safe procedure which only takes around 15 minutes to complete. The procedure is done with local anaesthetic to numb your throat, and you may choose to have additional sedation. If you do receive sedation, we may need to observe you for an hour or two after the procedure until the effects have worn off. Otherwise you can typically leave immediately. 

The inhaled intervention is called Sargramostim (GM-CSF). In order to determine its effectiveness, we also use an inhaled placebo (sterile water). For this reason, we aim to see all participants twice, providing they are happy to return. On one week you would receive inhaled GM-CSF, and on the other week (after a gap of at least a month) you would receive a placebo. Neither you nor the researcher would know which intervention you are receiving.

We are extremely grateful for volunteers and the time they sacrifice to be part of research studies. We offer a small fee as a token of our appreciation (this can be paid either as a voucher or bank transfer):

• Following your first week with the study we offer £150
• For completing your second week of the study we offer a further £200

The full participant information sheet contains expanded information on every aspect of the trial and will be provided to you should you wish to formally register your interest.