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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Skin Prick Test

Intervention Type PROCEDURE

Impulse Oscillometry

Intervention Type PROCEDURE

Exhaled Nitric Oxide

Intervention Type PROCEDURE

Spirometry

Intervention Type PROCEDURE

Reversibility

Intervention Type PROCEDURE

Exhaled Breath Condensate

Intervention Type PROCEDURE

Sputum Induction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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.

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes