- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00180752
HDAC Activity in Peripheral Skeletal Muscle in COPD
February 17, 2016 updated by: Michael Polkey, Imperial College London
The Investigation of HDAC and NF Kappa B Activity in Peripheral Skeletal Muscle in COPD
We wish to study the effect of Chronic Obstructive Pulmonary Disease on the activity of the nuclear transcription pathway in peripheral skeletal muscle to determine whether altered activity of this pathway may be responsible for the muscle dysfunction observed in these patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Peripheral muscle dysfunction is well recognised in COPD.
We wish to study patients who we have found to have weak quadriceps muscles and study the molecular mechanisms underlying this problem.
Patients will be well characterised with regard to their physiologic parameters and quadriceps muscle biopsies will be taken.
These biopsy samples will be analysed with respect to NFkappaB activity and HDAC activity by nuclear extraction and for muscle inflammatory cytokines.
We know that in the lung tissue of COPD patients there is evidence of a reduction in HDAC activity which might be responsible for the higher levels of pronflammatory cytokines in the lung.
We will also study a healthy control group and a small selection of patients who are in respiratory failure due to idiopathic scoliosis in the same way.
Study Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW3 6NP
- Royal Brompton Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
COPD patients and healthy age-and sex-matched controls
Description
Inclusion Criteria:
COPD
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Exclusion Criteria:
Aspirin therapy Bleeding diasthesis Neuromuscular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael I Polkey, PhD, Royal Brompton & Harefield NHS Foundation Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Agusti A, Morla M, Sauleda J, Saus C, Busquets X. NF-kappaB activation and iNOS upregulation in skeletal muscle of patients with COPD and low body weight. Thorax. 2004 Jun;59(6):483-7. doi: 10.1136/thx.2003.017640.
- Ito K, Ito M, Elliott WM, Cosio B, Caramori G, Kon OM, Barczyk A, Hayashi S, Adcock IM, Hogg JC, Barnes PJ. Decreased histone deacetylase activity in chronic obstructive pulmonary disease. N Engl J Med. 2005 May 12;352(19):1967-76. doi: 10.1056/NEJMoa041892.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
February 19, 2016
Last Update Submitted That Met QC Criteria
February 17, 2016
Last Verified
August 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- MusHDAC -1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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