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Completed

NCT Number: NCT01014338

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fosinopril

Drug

10mg od

Lactose

Other

placebo

Primary outcomes

  1. Changes in phosphorylation of components of the atrogene pathway

    Time frame: 3 months

Secondary outcomes

  1. Quadriceps endurance assessed non-volitionally

    Time frame: 3 months

  2. Effect of ACE-I on quadriceps maximum voluntary contraction force

    Time frame: 3 months

  3. Effect of ACE-I on quadriceps bulk (cross-sectional area)

    Time frame: 3 months

  4. Effect of ACE-I on systemic inflammation and serum IGF-1

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 17, 2009
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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