Evaluation and control of lung inflammation assessed with positron emission tomography (PET) scanning in emphysema
| ISRCTN | ISRCTN80875207 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80875207 |
| Secondary identifying numbers | 030547 |
- Submission date
- 22/10/2008
- Registration date
- 31/10/2008
- Last edited
- 04/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rob Stockley
Scientific
Scientific
Lung Investigation Unit
First Floor
Nuffield House
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Interventional single-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet. |
| Scientific title | Evaluation of the relative severity of pulmonary neutrophilic inflammation and therapeutic modification with intravenous prolastin by means of 18 fluoro-2-deoxyglucose (18FDG) positron emission tomography (PET)/computerised tomography (CT) scanning in subjects with usual chronic obstructive pulmonary disease (COPD) and alpha 1-antitrypsin deficiency |
| Study acronym | ECLIPSE-AATD |
| Study objectives | 18 fluoro-2-deoxyglucose (18FDG) positron emission tomography (PET)/computerised tomography (CT) scanning will enable non-invasive in vivo assessment of global neutrophilic inflammation in the lungs that relates to recognised biomarkers. It is anticipated that the level of lung inflammation will be highest in subjects with alpha 1-antitrypsin deficiency and lowest in healthy controls. Furthermore, it is anticipated that, following a 12-week treatment period of alpha 1-antitrypsin augmentation with intravenous (IV) prolastin, there will be a reduction in pulmonary inflammation that will be quantifiable with reference to subjects with usual chronic obstructive pulmonary disease (COPD) and healthy controls. |
| Ethics approval(s) | The study was approved by the Hammersmith and Queen Charlotte's and Chelsea REC on 08/08/2008 (ref: 08/H0707/46). |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD), emphysema, alpha 1-antitrypsin deficiency |
| Intervention | This is a proof of principle study. Study patients will acts as own controls by comparison between pre- and post-treatment measurements, and inter-group comparisons. Only those patients with alpha 1-antitrypsin deficiency will be treated with intravenous infusion of prolastin at a dose of 60 mg/kg per week for 12 consecutive weeks. Please use the following contact details to request a patient information sheet: Dr Anita Pye Lung Investigation Unit First Floor, Nuffield House Queen Elizabeth Hospital Edgbaston B15 2TH Birmingham United Kingdom Tel +44 (0)121 697 8256 Email: anita.pye@uhb.nhs.uk |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prolastin |
| Primary outcome measure | Quantitative PET/CT using Patlak plots of uptake of 18FDG by lung tissue as a surrogate measure of pulmonary neutrophilic inflammation. Primary and secondary outcome measures will be compared between groups at baseline. Only those patients with alpha 1-antitrypsin deficiency will be treated with prolastin, and comparison will be made between baseline and end of treatment values, within one week of treatment completion. |
| Secondary outcome measures | 1. Other biomarkers obtained from sputum, whole blood and plasma 2. Relationship between emphysema severity and neutrophilic inflammation by inter-individual and intra-individual comparisons Primary and secondary outcome measures will be compared between groups at baseline. Only those patients with alpha 1-antitrypsin deficiency will be treated with prolastin, and comparison will be made between baseline and end of treatment values, within one week of treatment completion. |
| Overall study start date | 01/11/2008 |
| Completion date | 01/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Healthy controls: 1. Healthy subjects 2. Both males and females, aged 50 - 70 years 3. Those who have never smoked regularly for more than 3 months 4. No evidence of lung disease 5. Forced expiratory volume in 1 second (FEV1) greater than 75% predicted, FEV1/forced vital capacity (FVC) greater than 70% predicted 6. No relevant medical or mental disorder 7. Able to give informed consent COPD patients: 1. Emphysema with no other active lung disease 2. FEV1 less than 75% predicted, FEV1/FVC less than 70% predicted, carbon monoxide transfer coefficient (KCO) less than 80% predicted (or known emphysema on previous CT scan) 3. Fewer than two acute exacerbations in the previous 12 months and no recent exacerbations (within 2 months) 4. No other relvant medical or mental disorder 5. Able to give informed consent Patients with alpha 1-antitrypsin deficiency: 1. PiZ phenotype 2. Emphysema with no other active lung disease 3. FEV1 less than 75% predicted, FEV1/FVC less than 70% predicted, KCO less than 80% predicted (or known emphysema on previous CT scan) 4. Fewer than two acute exacerbations in the previous 12 months and no recent exacerbations (within 2 months) 5. No other relvant medical or mental disorder 6. Able to give informed consent |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 01/02/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lung Investigation Unit
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
University Hospitals Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Edgbaston
Birmingham
B15 2TH
England
United Kingdom
| Website | http://www.uhb.nhs.uk |
|---|---|
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Government
Department of Health (UK) - Technology Platform Grant
No information available
Talecris Biotherapeutics (USA)
No information available
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 | 01/12/2012 | Yes | No |
