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

ACE-inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01014338

Enrollment

Registered

2009-11-17

Start date

2009-10-31

Completion date

2012-09-30

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

DRUGFosinopril

10mg od

OTHERlactose

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Changes in phosphorylation of components of the atrogene pathway	3 months

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026