Chronic obstructive pulmonary disease (COPD), emphysema, alpha 1-antitrypsin deficiency Respiratory Emphysema
Conditions
Interventions
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-a
Sponsors
University Hospitals Birmingham NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Does not comply with the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed