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

NCT00291408 | Withdrawn Phase 4

• 2 other identifiers: 05/Q0403/171EudraCT Number: 2005-003297-13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• HDAC and HAT activity ratio

Secondary Outcomes (1)

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

Interventions

Skin Prick Test PROCEDURE

Impulse Oscillometry PROCEDURE

Exhaled Nitric Oxide PROCEDURE

Spirometry PROCEDURE

Reversibility PROCEDURE

Exhaled Breath Condensate PROCEDURE

Sputum Induction PROCEDURE

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• AstraZeneca: collaborator

Study Sites (1)

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

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 14, 2006
• Study Start: April 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

GB (1)