Can lung inflammation be reduced by temporarily removing specific white blood cells from the bloodstream?
| ISRCTN | ISRCTN42695423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42695423 |
| Secondary identifying numbers | N/A |
- 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
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 |
|---|---|
| A.J.Simpson@ed.ac.uk |
Study information
| Study design | Single centre double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Magnitude of LPS-induced neutrophilia after treatment assessed by selective mononuclear leukapheresis, sample taken at 8 hours. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/08/2009 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 42 (Study A: 6; Study B: 6; Study C [RCT]: 30) |
| 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
- Scotland
- United Kingdom
Study participating centre
Room C2.12, MRC CIR
Edinburgh
EH16 4TJ
United Kingdom
EH16 4TJ
United Kingdom
Sponsor information
University of Edinburgh (UK)
University/education
University/education
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Website | http://www.ed.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Charity
Sir Jules Thorn Charitable Trust (UK) (ref: DHR/amh)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Sir Jules Thorn Charitable Trust
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
