Effect of Symbicort on HAT and HDAC in Sputum Macrophages of COPD
Information source: Imperial College London
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD); Age Matched Healthy Volunteers (Non-Smokers)
Intervention: Skin Prick Test (Procedure); Impulse Oscillometry (Procedure); Exhaled Nitric Oxide (Procedure); Spirometry (Procedure); Reversibility (Procedure); Exhaled Breath Condensate (Procedure); Sputum Induction (Procedure)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Imperial College London Official(s) and/or principal investigator(s):
Peter J Barnes, MA DM DSc FRCP, Principal Investigator, Affiliation: Imperial College London
Kazuhiro Ito, PhD, Principal Investigator, Affiliation: Imperial College London
Ian Adcock, PhD, Principal Investigator, Affiliation: Imperial College London
Sergei A Kharitonov, MD PhD, Principal Investigator, Affiliation: Imperial College London
Overall contact:
Sergei A Kharitonov, MD PhD, Phone: 020 7351 8006, Ext: 8006, Email: s.kharitonov@imperial.ac.uk
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
Clinical Details
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Effect of Symbicort® and Pulmicort® on HAT and HDAC Expression and Activity in Induced Sputum Cells Obtained From COPD Patients.
Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: HDAC and HAT activity ratio
Secondary outcome: Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below.
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Sergei A Kharitonov, MD PhD, Phone: 020 7351 8006, Ext: 8006, Email: s.kharitonov@imperial.ac.uk
National Heart and Lung Institute, London SW3 6LY, United Kingdom; Not yet recruiting
Sergei A Kharitonov, MD PhD, Phone: +44 351 8006, Email: s.kharitonov@imperial.ac.uk
Additional Information
Starting date: April 2006
Last updated: February 13, 2006
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