Clinical Trial Results:
ACE-EPIC: ACE inhibitors to enhance the effects of pulmonary rehabilitation in COPD
Summary
|
|
EudraCT number |
2012-000413-36 |
Trial protocol |
GB |
Global end of trial date |
13 Jan 2016
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
31 Jul 2019
|
First version publication date |
31 Jul 2019
|
Other versions |
|
Summary report(s) |
ACE EPIC paper |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
WHRC_P37644
|
||
Additional study identifiers
|
|||
ISRCTN number |
ISRCTN79038750 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Imperial College, London
|
||
Sponsor organisation address |
South Kensington Campus, London, United Kingdom,
|
||
Public contact |
Lucy Parker, Imperial College, +44 20 7594 1554, lucy.parker@imperial.ac.uk
|
||
Scientific contact |
Lucy Parker, Imperial College, +44 20 7594 1554, lucy.parker@imperial.ac.uk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
13 Jan 2016
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
13 Jan 2016
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
13 Jan 2016
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
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.
|
||
Protection of trial subjects |
Standard GCP for research.
|
||
Background therapy |
Standard therapy (pulmonary rehabilitation) | ||
Evidence for comparator |
ACE-I use and ACE gene polymorphisms are associated with muscle phenotype. See submitted paper. | ||
Actual start date of recruitment |
01 Oct 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 80
|
||
Worldwide total number of subjects |
80
|
||
EEA total number of subjects |
80
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
40
|
||
From 65 to 84 years |
40
|
||
85 years and over |
0
|
|
|||||||||||||||||||
Recruitment
|
|||||||||||||||||||
Recruitment details |
2 patients withdrew from the study before randomisation | ||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||
Screening details |
Patients with stable COPD in Global Initiative for Chronic Obstructive Lung Disease stages II to IV, who were referred for PR and who had a Medical Research Council dyspnea score of at least 3 or 2 with functional limitation, were considered for inclusion. | ||||||||||||||||||
Period 1
|
|||||||||||||||||||
Period 1 title |
overall trial (overall period)
|
||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Data analyst, Carer, Assessor | ||||||||||||||||||
Arms
|
|||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||
Arm title
|
Enalapril | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Enalapril
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Capsule
|
||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||
Dosage and administration details |
Enalapril 10mg od
|
||||||||||||||||||
Arm title
|
control | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Capsule
|
||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||
Dosage and administration details |
1 capsule per day
|
||||||||||||||||||
|
|||||||||||||||||||
Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 2 withdrew between enrolment and randomisation. |
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Enalapril
|
||
Reporting group description |
- | ||
Reporting group title |
control
|
||
Reporting group description |
- |
|
|||||||||||||
End point title |
Change in peak workload on cycle ergometry | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
10 weeks
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Unpaired T test | ||||||||||||
Comparison groups |
Enalapril v control
|
||||||||||||
Number of subjects included in analysis |
65
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
|
|||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Overall trial
|
||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||
Dictionary name |
SNOMED CT | ||||||||||||||||||||||||||||||
Dictionary version |
2015
|
||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
Enalapril
|
||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||
Reporting group title |
Control
|
||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |