NCT01014338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2009

Typical duration for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 25, 2015

Status Verified

June 1, 2011

Enrollment Period

2.9 years

First QC Date

November 16, 2009

Last Update Submit

March 24, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Changes in phosphorylation of components of the atrogene pathway

    3 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

ACE-inhibitor

ACTIVE COMPARATOR
Drug: Fosinopril

Sugar Pill

PLACEBO COMPARATOR
Other: lactose

Interventions

FosinoprilDRUG

10mg od

ACE-inhibitor
lactoseOTHER

placebo

Sugar Pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient with COPD diagnosed according to GOLD criteria.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (4)

  • Hopkinson NS, Nickol AH, Payne J, Hawe E, Man WD, Moxham J, Montgomery H, Polkey MI. Angiotensin converting enzyme genotype and strength in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Aug 15;170(4):395-9. doi: 10.1164/rccm.200304-578OC. Epub 2004 Apr 29.

    PMID: 15117739BACKGROUND

  • Swallow EB, Reyes D, Hopkinson NS, Man WD, Porcher R, Cetti EJ, Moore AJ, Moxham J, Polkey MI. Quadriceps strength predicts mortality in patients with moderate to severe chronic obstructive pulmonary disease. Thorax. 2007 Feb;62(2):115-20. doi: 10.1136/thx.2006.062026. Epub 2006 Nov 7.

    PMID: 17090575BACKGROUND

  • Hopkinson NS, Eleftheriou KI, Payne J, Nickol AH, Hawe E, Moxham J, Montgomery H, Polkey MI. +9/+9 Homozygosity of the bradykinin receptor gene polymorphism is associated with reduced fat-free mass in chronic obstructive pulmonary disease. Am J Clin Nutr. 2006 Apr;83(4):912-7. doi: 10.1093/ajcn/83.4.912.

    PMID: 16600946BACKGROUND

  • Andreas S, Herrmann-Lingen C, Raupach T, Luthje L, Fabricius JA, Hruska N, Korber W, Buchner B, Criee CP, Hasenfuss G, Calverley P. Angiotensin II blockers in obstructive pulmonary disease: a randomised controlled trial. Eur Respir J. 2006 May;27(5):972-9. doi: 10.1183/09031936.06.00098105. Epub 2006 Jan 30.

    PMID: 16446313BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

FosinoprilLactose

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphinic AcidsOrganophosphorus CompoundsOrganic ChemicalsProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Nicholas S Hopkinson, MRCP, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 17, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 25, 2015

Record last verified: 2011-06

Locations

GB(1)