ACE-EPIC: ACE inhibitors to enhance the effect of pulmonary rehabilitation in COPD

ACE-EPIC: ACE inhibitors to enhance the effects of pulmonary rehabilitation in COPD - ACE-EPIC: Enhancing the effects of pulmonary rehabilitation in COPD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000413-36-GB

Enrollment

Registered

2012-03-28

Start date

2012-04-27

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Enalapril 10mg Product Name: Enalapril 10mg Pharmaceutical Form: Tablet INN or Proposed INN: Enalapril maleate CAS Number: 7

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: GOLD stage II-IV COPD Clinical indication for PR (MRC score of >3 or functionally limited) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to establish whether enalapril can augment the effects of pulmonary rehabilitation on patients with COPD. This will focus on exercise capacity measured using cycle ergometry but data will also be collected on strength, body composition, physical activity level and health related quality of life.;Primary end point(s): The primary endpoint will be change in peak workload achieved on a cycle ergometer. ;Timepoint(s) of evaluation of this end point: This will be measured before and then after competion of an 8 week course of pulmonary rehabilitation.;Secondary Objective: A secondary objective is to evaluate the impact of ACE inhibition on pathways of muscle turnover (synthesis/breakdown)in COPD.	—

Measure

Time frame

Main Objective: The objective of the study is to establish whether enalapril can augment the effects of pulmonary rehabilitation on patients with COPD. This will focus on exercise capacity measured using cycle ergometry but data will also be collected on strength, body composition, physical activity level and health related quality of life.;Primary end point(s): The primary endpoint will be change in peak workload achieved on a cycle ergometer. ;Timepoint(s) of evaluation of this end point: This will be measured before and then after competion of an 8 week course of pulmonary rehabilitation.;Secondary Objective: A secondary objective is to evaluate the impact of ACE inhibition on pathways of muscle turnover (synthesis/breakdown)in COPD.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints will be (i) Quadriceps strength (ii) Six minute walk distance (iii) HRQOL (CAT score) (iv) Physical activity level. Exploratory endpoints – Impact of ACE-I on pathways of muscle synthesis/atrophy ;Timepoint(s) of evaluation of this end point: All endpoints measured at baseline and after an 8 week pulmonary rehabilitation programme.	—

Countries

United Kingdom

Contacts

Public ContactLucy Parker

Imperial College

lucy.parker@imperial.ac.uk020 7594 1554

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026