- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00291408
Effect of Symbicort on HAT and HDAC in Sputum Macrophages of COPD
August 5, 2019 updated by: Imperial College London
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.
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
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW3 6LY
- Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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HDAC and HAT activity ratio
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Secondary Outcome Measures
Outcome Measure |
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Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter J Barnes, MA DM DSc FRCP, Imperial College London
- Principal Investigator: Kazuhiro Ito, PhD, Imperial College London
- Principal Investigator: ian adcock, PhD, Imperial College London
- Principal Investigator: Sergei A Kharitonov, MD PhD, Imperial College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
February 13, 2006
First Submitted That Met QC Criteria
February 13, 2006
First Posted (Estimate)
February 14, 2006
Study Record Updates
Last Update Posted (Actual)
August 7, 2019
Last Update Submitted That Met QC Criteria
August 5, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- 05/Q0403/171
- EudraCT Number: 2005-003297-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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