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

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ClinicalTrials.gov Identifier: NCT00291408
Recruitment Status : Withdrawn (Researchers left the institute)
First Posted : February 14, 2006
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Imperial College London

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

Condition or disease Intervention/treatment 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 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
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 Start Date : April 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007



Primary Outcome Measures :
  1. HDAC and HAT activity ratio

Secondary Outcome Measures :
  1. Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291408


Locations
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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
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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

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ClinicalTrials.gov Identifier: NCT00291408     History of Changes
Other Study ID Numbers: 05/Q0403/171
EudraCT Number: 2005-003297-13
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Nitric Oxide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents