Effect of Symbicort on HAT and HDAC in Sputum Macrophages of COPD

Imperial College London

Status and phase

Withdrawn

Phase 4

Conditions

Age Matched Healthy Volunteers (Non-smokers)

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Procedure: Sputum Induction

Procedure: Reversibility

Procedure: Exhaled Nitric Oxide

Procedure: Exhaled Breath Condensate

Procedure: Spirometry

Procedure: Impulse Oscillometry

Procedure: Skin Prick Test

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00291408

05/Q0403/171

EudraCT Number: 2005-003297-13

Details and patient eligibility

About

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

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

Exclusion Criteria-Healthy non-smokers

Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
Upper respiratory infection within the last 4 weeks
Subjects who have received research medication within the previous one month
Subjects unable to give informed consent
Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.

Exclusion Criteria-COPD patients

Evidence of asthma
Bronchodilator reversibility > 12%
Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
Patients who have had oral steroids within 8 weeks prior to the screening visit.
Patients who are already on ICS and in which it is considered unsafe (as judged by the Investigator) to stop this treatment for the study period.
Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the screening visit.
Upper respiratory infection within the last 4 weeks
Subjects who have received research medication within the previous one month
Subjects unable to give informed consent
Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study
Patients with significant co-morbidities as judged by the investigator
Any other respiratory disease, which is considered by the investigator to be clinically significant