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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Richard Davidson
None provided
richard.davidson@ncl.ac.uk


Dr Jon Scott
None provided
jonathan.scott3@newcastle.ac.uk


Prof John Simpson
+44 (0)191 2137435
j.simpson@ncl.ac.uk


Dr Other public and general enquiries
None available
insight.am@ncl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Investigating the effects of a novel inhaled intervention on the function of alveolar macrophage cells in the lung
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Investigating the effects of a novel inhaled intervention on the function of alveolar macrophage cells in the lung

Recruiting

Open to: All Genders

Age: Adult

Newcastle upon Tyne Sunderland Newcastle upon Tyne

Medical Conditions

Respiratory

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Human lungs contain specialised cells (alveolar macrophages, AMs) that detect inhaled germs. In mice, AM function depends on a molecule called GM-CSF. How GM-CSF influences human AM function is poorly understood. Older people and critically ill patients are at increased risk of pneumonia, potentially because their AMs function less well. It is therefore possible that inhaled GM-CSF could boost AM function and prevent pneumonia and similar diseases in people at high risk. This study aims to learn more about the role of GM-CSF in human AM function, why AMs function less well as you age or while you are critically unwell, and to determine if giving GM-CSF as an inhaled intervention may offer protection against pneumonia and similar diseases. The study will provide entirely novel information about human AM function. A beneficial, safe role for inhaled GM-CSF may suggest future trials assessing whether this treatment can safely prevent pneumonia in patients at the highest risk.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

22 Jan 2024 31 Jan 2026

Twenty healthy young people who answer an advert and provide informed, written consent will inhale GM-CSF or a “dummy” treatment (placebo) on two consecutive days. Neither the participant nor the research team will know which has been inhaled. On the third day, the participant’s lungs will be “washed” in the hospital to retrieve AMs. These will be taken to a laboratory where their capacity to kill bacteria will be tested, with the identification of molecules involved in these processes. Participants will repeat this process after at least a month, except if they inhaled GM-CSF last time, they will inhale a placebo next time (and vice versa).

Twenty healthy older people will complete the same procedures as described above.

Twenty critically ill patients will receive inhaled GM-CSF or the placebo on two days and have their lungs washed on the third (i.e. they will undergo the procedures once only).

Finally, the study will determine whether laboratory-derived AM-like cells can faithfully mimic human AM function (to potentially avoid washing peoples’ lungs to get AMs in the future) – therefore, up to twenty healthy people will have a lung wash with no inhalation procedures and function in AMs and AM-like cells with be compared.


Young and healthy non-smoking participants (age 18-30), older and healthy non-smoking participants (aged 60 and over), adult participants who are critically unwell from intensive care units, and healthy non-smoking participants aged 18 or over for a final element of the study.

You can take part if:



You may not be able to take part if:


Younger healthy participants:1. SARS-CoV-2 positive 2. Current smoker of cigarettes or e-cigarettes 3. Past smoking history of > = 2 pack-years 4. Any smoking in the last year 5. Pregnancy or lactation6. Temperature > = 38ºc7. Systolic blood pressure < 90 mmhg8. Evidence of atrial or ventricular arrhythmia on ecg9. Oxygen saturations < 94% breathing room air10. FEV1 < 80% of predicted11. FEV1:FVC ratio < 70% predicted12. Haemoglobin < 10 g/L13. Blood platelets < 100x109/L14. Estimated GFR < 60ml/min/1.73m215. Any previous cardiovascular events16. Diabetes17. Known allergy to GM-CSF, yeast-derived products, mannitol, sucrose or tromethamine18. Regular prescribed oral, inhaled, subcutaneous or intravenous medication with the following exceptions:18.1. Topical skin treatments18.2. Contraceptives18.3. PPIs18.4. Drugs for constipation18.5. Levothyroxine 18.6. Aspirin18.7. Paracetamol18.8. Codeine

Older healthy participants:1. SARS-cov-2 positive 2. Current smoker of cigarettes or e-cigarettes 3. Past smoking history of > = 2 pack-years any smoking in the last year 4. Pregnancy or lactation5. Temperature > = 38ºc6. Systolic blood pressure < 90 mmhg7. Evidence of atrial or ventricular arrhythmia on ECG8. Oxygen saturations < 94% breathing room air9. FEV1 < 80% of predicted10. FEV1:FVC ratio < 70% predicted11. Haemoglobin < 10 g/L12. Blood platelets < 100x109/L13. Estimated GFR < 60ml/min/1.73m214. Any previous cardiovascular events15. Diabetes16. Known allergy to GM-CSF, yeast derived products, mannitol, sucrose or tromethamine17. Regular prescribed oral, inhaled, subcutaneous or intravenous medication with the following exceptions:17.1. Topical skin treatments17.2. Contraceptives17.3. Hormone Replacement Therapy17.4. Antihypertensives (single agent only)17.5. PPIs17.6. Drugs for constipation17.7. Levothyroxine 17.8. Aspirin17.9. Paracetamol17.10. Codeine

Participants in ICU:The majority of the exclusion criteria relate to factors known to increase risk of complications at bronchoscopy and BAL. 1. Known allergy to GM-CSF, yeast derived products, mannitol, sucrose or tromethamine2. Current treatment for pneumonia (i.e. If treating clinicians have prescribed antibiotics specifically to treat suspected or confirmed pneumonia)3. Arterial partial pressure (pao2) less than 8 kpa on fio2 greater than 0·74. Positive end-expiratory pressure greater than 15 cmh2o5. Peak airway pressure greater than 35 cmh2o6. Heart rate greater than 140 beats per minute7. Mean arterial pressure less than 65 mmhg8. Bleeding diathesis (platelet count < 20×10^9/L or international normalised ratio > 3)9. Intracranial pressure greater than 20 mmhg10. Estimated GFR < 15 ml/min/1.73m2 11. Immunosuppressant medication (maintenance corticosteroids up to an equivalent of prednisolone 10mg once daily will be eligible for inclusion) 12. Pregnancy or lactation13. ICU consultant considers bronchoscopy and bronchoalveolar lavage to be unsafe for the patient

Participants for Bronchoscopy-only element:1. SARS-cov-2 positive 2. Current smoker of cigarettes or e-cigarettes 3. Past smoking history of > = 2 pack-years 4. Any cigarette smoking in the last year 5. Pregnancy or lactation6. Temperature > = 38ºc7. Systolic blood pressure < 90 mmhg8. Evidence of atrial or ventricular arrhythmia on ECG9. Oxygen saturations < 94% breathing room air10. FEV1 < 80% of predicted11. FEV1:FVC ratio < 70% predicted12. Haemoglobin < 10 g/L13. Blood platelets < 100x109/L14. Estimated GFR < 60ml/min/1.73m215. Any previous cardiovascular events16. Diabetes17. Regular prescribed oral, inhaled, subcutaneous or intravenous medication with the following exceptions:17.1. Topical skin treatments17.2. Contraceptives17.3. Hormone Replacement Therapy17.4. Antihypertensives (single agent only)17.5. Ppis17.6. Drugs for constipation17.7. Levothyroxine 17.8. Aspirin17.9. Paracetamol17.10. Codeine


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Victoria Infirmary
    Queen Victoria Road
    Newcastle upon Tyne
    NE1 4LP
  • Sunderland Royal Hospital
    Kayll Road
    Sunderland
    SR4 7TP
  • Freeman Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN

For the healthy participants, there are not expected to be any direct benefits to the individual. There are risks involved with receiving a medical intervention and procedure that are not clinically required. The inhaled GM-CSF has a well-established safety profile. Side effects such as fever, headaches, wheezing or allergic reactions are rare. Participants will be monitored all after they receive the intervention. The bronchoscopy can be uncomfortable for some people and can cause minor side effects such as cough, sore throat and fever. While the study is reliant on the generosity of potential participants a small reimbursement will be planned for their time and inconvenience.
The critically ill participants may theoretically derive a benefit should they be randomised to receive GM-CSF and it is proved to help augment the function of their AMs. There is, however, no guarantee that they will derive any benefit at all. Patient safety is a priority and neither the nebulised intervention nor the bronchoscopy will be given if there are concerns about the safety of the participant given their critical illness state.

Dr Richard Davidson
None provided
richard.davidson@ncl.ac.uk


Dr Other public and general enquiries
None available
insight.am@ncl.ac.uk


Dr Jon Scott
None provided
jonathan.scott3@newcastle.ac.uk


Prof John Simpson
+44 (0)191 2137435
j.simpson@ncl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by Medical Research Council; National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN78203402

Or CPMS 58971

Last updated 16 April 2025

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