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

Imperial College London logo

Imperial College London

Status and phase

Completed
Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Other: lactose
Drug: Fosinopril

Study type

Interventional

Funder types

Other

Identifiers

NCT01014338
P15099
ISRCTN05581879 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

ACE-inhibitor
Active Comparator group
Treatment:
Drug: Fosinopril
Sugar Pill
Placebo Comparator group
Treatment:
Other: lactose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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