Chronic Obstructive Pulmonary Disease | Angiotensin-converting Enzyme (ACE)-Inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease research study
What is the primary objective of this study?
A double blind randomised placebo controlled parallel trial of the effect of fosinopril, an angiotensin converting enzyme inhibitor, on the quadriceps muscle in 80 COPD patients who have quadriceps weakness. Patients will have a baseline assessment including measures of quadriceps strength and endurance and a quadriceps biopsy. Patients with weakness will be randomised to ACE inhibitor or placebo and re-assessed after three months of treatment. The investigators aim to show that ACE-inhibition will alter the IGF-1/AKT/FoXO/atrogene pathways involved in muscle wasting in COPD.
Who is eligible to participate?
Inclusion Criteria: - Adult patient with COPD diagnosed according to GOLD criteria. Exclusion Criteria: - Clinically unstable patients (within one month of exacerbation), those with a permanent pacemaker (which is a contraindication to magnetic stimulation), or significant co-morbidity, patients with an accepted indication for ACE inhibition (left ventricular dysfunction, diabetes) or a contraindication such as renovascular disease; creatinine clearance (estimated) <50); hypotension; use of anticoagulants (contra-indication to biopsy) or ACE-I or ATII receptor antagonists. - Allergy to ACE-inhibitors. - Pregnancy. Patients will not be enrolled within three months of participation in a pulmonary rehabilitation program.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Obstructive Pulmonary Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2009
Completed Date: September 2012
Phase: Phase 4
Primary Outcome: Changes in phosphorylation of components of the atrogene pathway
Secondary Outcome: Quadriceps endurance assessed non-volitionally
Study sponsors, principal investigator, and references
Principal Investigator: Nicholas S Hopkinson, MRCP, PhD
Lead Sponsor: Imperial College London
Collaborator: Medical Research Council
Hopkinson NS, Nickol AH, Payne J, Hawe E, Man WD, Moxham J, Montgomery H, Polkey MI. Angiotensin converting enzyme genotype and strength in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Aug 15;170(4):395-9. Epub 2004 Apr 29.