Evaluation of the relative severity of pulmonary neutrophilic inflammation and therapeutic modification with IV Prolastin by means of 18 FDG PET/CT scanning in subjects with alpha1-antitrypsin deficiency. - ECLIPSE AATD

Phase 1

• Conditions: The medical condition is emphysema and will be investigated in subjects with alpha 1-antitrypsin deficiency.; MedDRA version: 9.1 Level: LLT Classification code 10001811 Term: Alpha-1 proteinase inhibitor deficiency; MedDRA version: 9.1 Level: LLT Classification code 10014563 Term: Emphysema pulmonary; MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD; MedDRA version: 9.1 Level: LLT Classification code 10006458 Term: Bronchitis chronic

• Registration Number: EUCTR2007-004869-18-GB
• Lead Sponsor: HB NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

Three subject groups of individuals over the age of 50 years will be studied.
Healthy never smokers age 50-70 years, no evidence of lung disease, FEV1>75% predicted, FEV1/VC>70%, no relevant medical or mental disorder, able to give informed consent.

Patients with an emphysema COPD phenotype (and normal alpha 1-antitrypsin phenotype), no other active lung disease, FEV1<75% predicted, FEV1/VC<70%, KCO<80% predicted (or known emphysema on previous CT scan), fewer than two acute exacerbation in the previous 12 months and no recent exacerbations, no smoking history within the preceding 12 months, no other relevant medical or mental disorder, able to give informed consent.

Patients with an emphysema COPD phenotype (PiZ alpha 1-antitrypsin phenotype, no other active lung disease, FEV1<75% predicted, FEV1/VC<70%, KCO<80% predicted (or known emphysema on previous CT scan), fewer than two acute exacerbation in the previous 12 months and no recent exacerbations, no smoking history within the preceding 12 months, no other relevant medical or mental disorder, able to give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age <50 or >80
Continued smoking
Frequent or recent acute exacerbations of COPD
Other lung disorder
Relevant medical or mental illness
Diabetes

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified