Angiotensin-converting Enzyme (ACE)-Inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: lactose; Drug: Fosinopril

• Registration Number: NCT01014338
• Lead Sponsor: Imperial College London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Status Verified: 2011-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar Pill	lactose	-
ACE-inhibitor	Fosinopril	-

Primary Outcome Measures

Name	Time	Method
Changes in phosphorylation of components of the atrogene pathway	3 months

Secondary Outcome Measures

Name	Time	Method
Quadriceps endurance assessed non-volitionally	3 months
Effect of ACE-I on quadriceps maximum voluntary contraction force	3 months
Effect of ACE-I on quadriceps bulk (cross-sectional area)	3 months
Effect of ACE-I on systemic inflammation and serum IGF-1	3 months

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom