Chronic Obstructive Pulmonary Disease (COPD), Age Matched Healthy Volunteers (Non-smokers)
Conditions
Brief summary
The purpose of the study is to compare histone acetyltransferase (HAT) and histone deacetylase (HDAC) expressions and activities in induced sputum macrophages obtained from patients with moderate to severe COPD and age-matched normal non-smokers
Interventions
PROCEDURESkin Prick Test
PROCEDUREImpulse Oscillometry
PROCEDUREExhaled Nitric Oxide
PROCEDURESpirometry
PROCEDUREReversibility
PROCEDUREExhaled Breath Condensate
PROCEDURESputum Induction
Sponsors
AstraZeneca
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria-Healthy non-smokers * Non-smoking volunteer * aged 40 -75 years (age matched to COPD patients) * Normal spirometry (normal FEV1/FVC ratio \>70% and FEV1\>80% predicted) * Subjects are able to give informed consent Inclusion Criteria-COPD patients (stage II-III according to the GOLD guidelines) * Current and/or ex-smokers with no less than 10 pack-year smoking history * aged 40 -75 years * FEV1 greater than or equal to 30% and less than 80% of predicted (the upper value is a prostbronchodilator value) * FEV1/FVC \< 70% * Patients with stable COPD * Inhaled Corticosteroid (ICS) treatment, if exists, must be stopped for 2 weeks prior the study treatment * Long-acting beta2-agonists and theophylline need to be stopped at least 3 days before run-in , but anti-cholinergics will be allowed throughout the study * The subjects are able to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HDAC and HAT activity ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below. | — |
Countries
United Kingdom
Outcome results
None listed