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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medical Research Council
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01014338
First received: November 16, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Fosinopril
Other: lactose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: ACE-inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Changes in phosphorylation of components of the atrogene pathway [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quadriceps endurance assessed non-volitionally [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effect of ACE-I on quadriceps maximum voluntary contraction force [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effect of ACE-I on quadriceps bulk (cross-sectional area) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effect of ACE-I on systemic inflammation and serum IGF-1 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACE-inhibitor Drug: Fosinopril
10mg od
Placebo Comparator: Sugar Pill Other: lactose
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014338

Contacts
Contact: Dinesh Shrikrishna, BSc, MRCP 0207 351 8029 d.shrikrishna@ic.ac.uk
Contact: Nicholas S Hopkinson, MRCP, PhD

Locations
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Dinesh Shrikrishna, BSc, MRCP    0207 351 8029      
Principal Investigator: Nicholas S Hopkinson, MRCP, PhD         
Sub-Investigator: Dinesh Shrikrishna, BSc, MRCP         
Sponsors and Collaborators
Imperial College London
Medical Research Council
Investigators
Principal Investigator: Nicholas S Hopkinson, MRCP, PhD Imperial College London
  More Information

Publications:
Responsible Party: Gary Roper, Imperial College London
ClinicalTrials.gov Identifier: NCT01014338     History of Changes
Other Study ID Numbers: P15099, ISRCTN05581879
Study First Received: November 16, 2009
Last Updated: June 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Muscle Weakness
Paresis
Pulmonary Disease, Chronic Obstructive
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014