Investigating the effects of a novel inhaled intervention on the function of alveolar macrophage cells in the lung
- Conditions
- Respiratory
- Registration Number
- ISRCTN78203402
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
Younger healthy participants:
1. Aged 18-30 years old
2. World Health Organization (WHO) Performance Status Score 0
3. Provision of informed, written consent from the participant
4. A negative highly sensitive urine pregnancy test for women of childbearing potential (WOCBP)*
(*A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile**. The post-menopausal state is defined as no menses for 12 months without an alternative medical cause.” When it cannot be confirmed that a participant is post-menopausal a pregnancy test will be conducted. **Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.)
Older healthy participants:
1. Aged > = 60 years old
2. WHO Performance Status Score 0
3. Provision of informed, written consent from the participant
4. A negative highly sensitive urine pregnancy test for women of childbearing potential (WOCBP)
Patients in the ICU:
1. Patients intubated and mechanically ventilated in ICU for > = 2 days
2. Provision of informed, written consent from a personal or legal representative
3. A negative highly sensitive urine pregnancy test for WOCBP
Bronchoscopy only:
1. Aged 18 or over old
2. WHO Performance Status Score 0
3. Provision of informed, written consent from the participant
4. A negative highly sensitive urine pregnancy test for women of childbearing potential (WOCBP)
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 lactation
6. Temperature > = 38ºc
7. Systolic blood pressure < 90 mmhg
8. Evidence of atrial or ventricular arrhythmia on ecg
9. Oxygen saturations < 94% breathing room air
10. FEV1 < 80% of predicted
11. FEV1:FVC ratio < 70% predicted
12. Haemoglobin < 10 g/L
13. Blood platelets < 100x109/L
14. Estimated GFR < 60ml/min/1.73m2
15. Any previous cardiovascular events
16. Diabetes
17. Known allergy to GM-CSF, yeast-derived products, mannitol, sucrose or tromethamine
18. Regular prescribed oral, inhaled, subcutaneous or intravenous medication with the following exceptions:
18.1. Topical skin treatments
18.2. Contraceptives
18.3. PPIs
18.4. Drugs for constipation
18.5. Levothyroxine
18.6. Aspirin
18.7. Paracetamol
18.8. 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 lactation
5. Temperature > = 38ºc
6. Systolic blood pressure < 90 mmhg
7. Evidence of atrial or ventricular arrhythmia on ECG
8. Oxygen saturations < 94% breathing room air
9. FEV1 < 80% of predicted
10. FEV1:FVC ratio < 70% predicted
11. Haemoglobin < 10 g/L
12. Blood platelets < 100x109/L
13. Estimated GFR < 60ml/min/1.73m2
14. Any previous cardiovascular events
15. Diabetes
16. Known allergy to GM-CSF, yeast derived products, mannitol, sucrose or tromethamine
17. Regular prescribed oral, inhaled, subcutaneous or intravenous medication with the following exceptions:
17.1. Topical skin treatments
17.2. Contraceptives
17.3. Hormone Replacement Therapy
17.4. Antihypertensives (single agent only)
17.5. PPIs
17.6. Drugs for constipation
17.7. Levothyroxine
17.8. Aspirin
17.9. Paracetamol
17.10. 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 tromethamine
2. 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 0·7
4. Positive end-expiratory pressure greater than 15 cmh2o
5. Peak airway pressure greater than 35 cmh2o
6. Heart rate greater than 140 beats per minute
7. Mean arterial pressure less than 65 mmhg
8. Bleeding diathesis (platelet count < 20×10^9/L or international normalised ratio > 3)
9. Intracranial pressure greater than 20 mmhg
10. 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 lactation
13. 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 lactation
6. Temperature > = 38ºc
7. Systolic blood pressure < 90 mmhg
8. Evidence of atrial or ventricular arrhythmia on ECG
9. Oxygen saturations < 94% breathing room air
10. FEV1 < 80% of predicted
11. FEV1:FVC ratio < 70% predicted
12
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method