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

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ClinicalTrials.gov Identifier: NCT01014338
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Fosinopril Other: lactose Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: ACE-inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease
Study Start Date : October 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Fosinopril

Arm Intervention/treatment
Active Comparator: ACE-inhibitor Drug: Fosinopril
10mg od

Placebo Comparator: Sugar Pill Other: lactose
placebo




Primary Outcome Measures :
  1. Changes in phosphorylation of components of the atrogene pathway [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014338


Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Medical Research Council
Investigators
Principal Investigator: Nicholas S Hopkinson, MRCP, PhD Imperial College London

Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01014338     History of Changes
Other Study ID Numbers: P15099
ISRCTN05581879 ( Registry Identifier: ISRCTN )
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: June 2011

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Muscle Weakness
Paresis
Respiratory Tract Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Fosinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents