Can lung inflammation be reduced by temporarily removing specific white blood cells from the bloodstream?

ISRCTN	ISRCTN42695423
DOI	https://doi.org/10.1186/ISRCTN42695423
Protocol serial number	N/A
Sponsor	University of Edinburgh (UK)
Funder	Sir Jules Thorn Charitable Trust (UK) (ref: DHR/amh)

Submission date: 16/04/2009
Registration date: 05/08/2009
Last edited: 05/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John Simpson
Scientific

Room C2.12, MRC CIR
Queens Medical Research Centre
Little France Crescent
University of Edinburgh
Edinburgh
EH16 4TJ
United Kingdom

Phone	+44 (0)131 242 6556/7
Email	A.J.Simpson@ed.ac.uk

Study information

Primary study design	Interventional
Study design	Single centre double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Trial of monocyte depletion in experimental lung inflammation: a single centre, double-blind, randomised, controlled trial
Study objectives	In a model of experimental acute lung inflammation in humans, monocyte depletion can ameliorate systemic and pulmonary inflammation.
Ethics approval(s)	Lothian research ethics committee (REC) 1 approved on the 11th May 2009 (ref: 09/S1101/27)
Health condition(s) or problem(s) studied	Experimental Lung Inflammation
Intervention	Study A: To characterise the relationship between blood neutrophil/monocyte accumulation and lung inflammation after inhalation of LPS. Duration of nebulised LPS intervention: 30 - 60 minutes Duration of Bronchoscopy and BAL: 30 minutes Study B: To characterise the effect of mononuclear cell depletion on lung inflammation. Duration of Leukapheresis: 3 - 6 hours (3 - 4 blood volume changes) Duration of Bronchoscopy and BAL: 30 minutes Study C: Can lung inflammation be reduced by temporarily removing specific white blood cells from the bloodstream? A randomised, double-blind, placebo-controlled trial. Duration of nebulised LPS intervention: 30 - 60 minutes Duration of Leukapheresis: 3 - 6 hours (3 - 4 blood volume changes) Duration of Bronchoscopy and BAL: 30 minutes Duration of CT-PET: 1 hour
Intervention type	Other
Primary outcome measure(s)	Magnitude of LPS-induced neutrophilia after treatment assessed by selective mononuclear leukapheresis, sample taken at 8 hours.
Key secondary outcome measure(s)	1. Alveolar pulmonary neutrophil accumulation and injury assessed by bronchoscopy, sample retrieved at 8.5 hours 2. Global pulmonary neutrophil accumulation and injury assessed by positron emission tomography (PET), sample retrieved at 8.5 hours 3. Cytokines in BAL fluid, sample retrieved at 8.5 hours 4. Protein and albumin in BAL fluid, sample retrieved at 8.5 hours 5. Change in oxygen saturation, recordings made every 1 hour (0 - 8 hours, 24 hours and as indicated) 6. Change in serum markers of inflammation, blood drawn 0, 2, 4, 6 and 8 hours (where 0 hours is time just before nebulised LPS) 7. Serial profile of blood neutrophils and monocytes, blood drawn at 0, 2, 4, 6 and 8 hours 8. PET values, scan is at 11 hours 9. Safety and tolerablility, measured throughout
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	42
Key inclusion criteria	Healthy male volunteers aged 18 - 40 years
Key exclusion criteria	1. Aged less than 18 years 2. History of any chronic or ongoing acute illness (with particular reference to asthma, upper respiratory tract infection, lower respiratory tract infection, bronchiectasis, congenital heart disease, ischaemic heart disease, valvular heart disease, diabetes mellitus, chronic renal impairment, urinary tract infection) 3. Current history of smoking 4. Past smoking history amounting to greater than two pack-years 5. Any history of smoking in the last 12 months 6. Reported alcohol intake greater than 21 units per week 7. Any current medication 8. Abnormal physical signs detected at cardiorespiratory examination 9. Temperature greater than 37.3°C 10. Oxygen saturation less than 95% breathing room air 11. Haemoglobin, white cell count or platelet count outside the laboratory reference range 12. Blood sodium, potassium, urea, creatinine, bilirubin, alanine aminotransferase, random glucose or C-reactive protein outside the laboratory reference range 13. Forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) less than 80% predicted 14. FEV1:FVC ratio less than 70% 15. Any cardiorespiratory abnormality detected on chest x-ray 16. Peripheral venous access insufficient to support bilateral 16 gauge cannulae
Date of first enrolment	01/08/2009
Date of final enrolment	31/07/2011

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Room C2.12, MRC CIR

Edinburgh
EH16 4TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes