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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00291408
First received: February 13, 2006
Last updated: April 4, 2008
Last verified: April 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Nitric Oxide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013