Clinical Trial Results:
Effects of GLP-1 receptor agonist treatment on pulmonary function and quality of life in obese patients with chronic obstructive pulmonary disease -
A prospective, randomized, placebo-controlled, double-blinded, parallel group, two-center trial for the evaluation of the effect of Liraglutide 3 mg daily on chronic obstructive pulmonary disease.
Summary
|
|
EudraCT number |
2017-003551-32 |
Trial protocol |
DK |
Global end of trial date |
19 Mar 2020
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
24 Jan 2025
|
First version publication date |
24 Jan 2025
|
Other versions |
|
Summary report(s) |
Abstract Respiratory Effects of Treatment with a Glucagon-Like Peptide-1 Receptor Agonist in Patients Suffering from Obesity and Chronic Obstructive Pulmonary Disease FDG-PET/CT-based respiration-gated lung segmentation and quantification of lung inflammation in COPD patients |
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 |
ISS-U1111-1188-8695
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT03466021 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Hospital of South West Jutland
|
||
Sponsor organisation address |
Finsensgade 35, Esbjerg, Denmark, 6700
|
||
Public contact |
Medical Department, Hospital of South West Jutland, 45 60867172, claus.bogh.juhl@rsyd.dk
|
||
Scientific contact |
Medical Department, Hospital of South West Jutland, 45 60867172, claus.bogh.juhl@rsyd.dk
|
||
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 |
01 Jul 2022
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
19 Mar 2020
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
19 Mar 2020
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The objective of the study is to evaluated the effect of Liraglutide 3mg on patient reported outcomes and objective measures of COPD
|
||
Protection of trial subjects |
Patients were regularly seen by a medical doctor, patients were informed about normal and abnormal findings throughout the trial
|
||
Background therapy |
Usual medication for chronic obstructive pulmonary disease. Systemic steroid permitted for intermittent use. | ||
Evidence for comparator |
Inhaled steroids, beta-2 agonists and anticholinergic agents are all well documentet treatments of chrinoc obstructive pulmonary disease. | ||
Actual start date of recruitment |
15 Jan 2018
|
||
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 |
Denmark: 40
|
||
Worldwide total number of subjects |
40
|
||
EEA total number of subjects |
40
|
||
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) |
14
|
||
From 65 to 84 years |
26
|
||
85 years and over |
0
|
|
||||||||||||||||
Recruitment
|
||||||||||||||||
Recruitment details |
Patients were recruited from the outpatient clinics for people with chronic obstructive pulmonary disease and from newspaper advertisements | |||||||||||||||
Pre-assignment
|
||||||||||||||||
Screening details |
Presence of chronic obstructive pulkmonary disease and BMI > 27kg/m2 | |||||||||||||||
Pre-assignment period milestones
|
||||||||||||||||
Number of subjects started |
40 | |||||||||||||||
Number of subjects completed |
40 | |||||||||||||||
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, Monitor, Data analyst, Carer, Assessor | |||||||||||||||
Blinding implementation details |
Use of matching placebo, unblinded after database-lock
|
|||||||||||||||
Arms
|
||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||
Arm title
|
Placebo | |||||||||||||||
Arm description |
Matching placebo | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
|
|||||||||||||||
Investigational medicinal product code |
NA
|
|||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Injection
|
|||||||||||||||
Routes of administration |
Subcutaneous use
|
|||||||||||||||
Dosage and administration details |
Abdominal injection
|
|||||||||||||||
Arm title
|
Liraglutide | |||||||||||||||
Arm description |
Liraglutide | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Liraglutide
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
Saxenda
|
|||||||||||||||
Pharmaceutical forms |
Injection
|
|||||||||||||||
Routes of administration |
Subcutaneous use
|
|||||||||||||||
Dosage and administration details |
Gradually increasing does starting with 0.6 mg daily, weekly uptitratetd to full dosis of 3.0 mg daily
|
|||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Matching placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Liraglutide
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Liraglutide | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Placebo
|
||
Reporting group description |
Matching placebo | ||
Reporting group title |
Liraglutide
|
||
Reporting group description |
Liraglutide |
|
|||||||||||||
End point title |
FVC | ||||||||||||
End point description |
Functional vital capacity, lung capacity, week 40
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 40
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Effect analysis | ||||||||||||
Statistical analysis description |
Effect of liraglutide compared to placebo
Intention to treat analysis
|
||||||||||||
Comparison groups |
Placebo v Liraglutide
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Random effect model | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Body weight | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
baseline to week 40
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Effect analysis | ||||||||||||
Statistical analysis description |
Compares the effecct of liraglutide with the effect of placebo
Intention to treat analysis
|
||||||||||||
Comparison groups |
Placebo v Liraglutide
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Random effect model | ||||||||||||
Parameter type |
Random effect model | ||||||||||||
Confidence interval |
|
||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||
Timeframe for reporting adverse events |
0-40 weeks
|
|||||||||||||||||||||
Adverse event reporting additional description |
Gastrointestinal side effects
|
|||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||
Dictionary name |
CTCAE | |||||||||||||||||||||
Dictionary version |
5.0
|
|||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||
Reporting group title |
Arm Liraglutide
|
|||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||
Reporting group title |
Arm Placebo
|
|||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||
|
||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0.05% | ||||||||||||||||||||||
|
|
|||
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 |