search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD), Age Matched Healthy Volunteers (Non-smokers)

Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Skin Prick Test
Impulse Oscillometry
Exhaled Nitric Oxide
Spirometry
Reversibility
Exhaled Breath Condensate
Sputum Induction
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

Outcomes

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.

Full Information

First Posted
February 13, 2006
Last Updated
August 5, 2019
Sponsor
Imperial College London
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00291408
Brief Title
Effect of Symbicort on HAT and HDAC in Sputum Macrophages of COPD
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 Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Researchers left the institute
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Imperial College London
Collaborators
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD), Age Matched Healthy Volunteers (Non-smokers)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Skin Prick Test
Intervention Type
Procedure
Intervention Name(s)
Impulse Oscillometry
Intervention Type
Procedure
Intervention Name(s)
Exhaled Nitric Oxide
Intervention Type
Procedure
Intervention Name(s)
Spirometry
Intervention Type
Procedure
Intervention Name(s)
Reversibility
Intervention Type
Procedure
Intervention Name(s)
Exhaled Breath Condensate
Intervention Type
Procedure
Intervention Name(s)
Sputum Induction
Primary Outcome Measure Information:
Title
HDAC and HAT activity ratio
Secondary Outcome Measure Information:
Title
Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Barnes, MA DM DSc FRCP
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kazuhiro Ito, PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian Adcock, PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sergei A Kharitonov, MD PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6LY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs