Effect of Symbicort on HAT and HDAC in Sputum Macrophages of COPD - Full Text View

Sponsors and Collaborators:	Imperial College London AstraZeneca
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00291408

Purpose

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

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD) Age Matched Healthy Volunteers (Non-Smokers)	Procedure: Skin Prick Test Procedure: Impulse Oscillometry Procedure: Exhaled Nitric Oxide Procedure: Spirometry Procedure: Reversibility Procedure: Exhaled Breath Condensate Procedure: Sputum Induction	Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Budesonide Symbicort Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics Study
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.

Further study details as provided by Imperial College London:

Primary Outcome Measures:

HDAC and HAT activity ratio

Secondary Outcome Measures:

Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below.

Estimated Enrollment:	48
Study Start Date:	April 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291408

Locations

United Kingdom
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom, SW3 6LY

Sponsors and Collaborators

Imperial College London

AstraZeneca

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

More Information

Study ID Numbers:	05/Q0403/171, EudraCT Number: 2005-003297-13
Study First Received:	February 13, 2006
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00291408
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Nitric Oxide
Lung Diseases, Obstructive
Symbicort
Respiratory Tract Diseases

Lung Diseases
Budesonide
Healthy
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents

Protective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009