Pulmonary Disease, Chronic ObstructivePhase 4NCT03466021
Effects of Liraglutide in Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Liraglutide in people with Pulmonary Disease, Chronic Obstructive, run by Claus Bogh Juhl at 2 sites in Denmark.
Trial summary
The study is a 44 weeks, prospective, randomized, placebo-controlled, double-blinded, parallel group two-center trial. Forty patients are recruited among the outpatients of the chronic obstructive pulmonary disease (COPD) clinic, Hospital of South West Jutland and Lillebælt Hospital according to the inclusion and… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jan 2018to 31 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities
- COPD as defined by FEV1/FVC<70% after maximal broncho-dilatation and in accordance with the Gold guidelines 2017 (25)
- Previous smoking of ≥ 20 pack-years
- Overweight defined as BMI > 27 kg/m2
- Age 30 - 75 years
- Women of childbearing potential must use a safe anti-contraceptive method
Who cannot join
- Chronic treatment with systemic steroids (inhalation steroids allowed)
- Current smokers
- Diabetes mellitus type 1 and type 2 as defined by current or previous treatment with antidiabetic medications of any kind or HbA1c ≥ 48mmol/mol
- Severe hepatic disease (Alanine transferase > 3 x UNL)
- Severe impaired renal function (eGFR < 30ml/min)
- Congestive heart disease New York Heart Association (NYHA) class 3-4
Show all 12Show fewer
- History of acute or chronic pancreatitis
- History of cholecystitis or cholecystolithiasis
- Pregnant or breastfeeding women
- Known bronchial asthma or interstitial lung disease
- Family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma
- Large goiter or plasma-calcitonin > 50ng/ml
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hospital of South West Jutland
Esbjerg, 6700
Lillebaelt Hospital
Vejle, 7100
About this study
Official title: Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease.
The study is a 44 weeks, prospective, randomized, placebo-controlled, double-blinded, parallel group two-center trial. Forty patients are recruited among the outpatients of the chronic obstructive pulmonary disease (COPD) clinic, Hospital of South West Jutland and Lillebælt Hospital according to the inclusion and exclusion criteria. The patients are randomized to receive liraglutide 3 mg per day (initial dose 0.6 mg, increasing by 0.6 mg weekly until 3 mg is reached) or placebo. At baseline, after four weeks (assessment of the acute effect of liraglutide), 20 weeks, and 40 weeks (assessment of the combined effect of liraglutide and weight loss) and at week 44 (assessment of the weight-loss after discontinuation of liraglutide) the patients are assessed by physical examination, carbon monoxide (CO) diffusion test, pulmonary function test, biomarkers of inflammation (CRP, interleucine-6 (IL-6), monocyte chemitactic protein-1 (MCP-1)), Fluorodeoxyglucose (FDG)/PET-CT scan of the lungs, 6-minute walking test, respiratory polygraphy and validated questionnaires including basic dyspnea index, transition dyspnea index, COPD Assessment Test (CAT)-score, short-form-36 (SF-36) and Epworth Sleepiness Score.
Read the detailed description
COPD is a common disease characterized by pulmonary inflammation, reduced pulmonary capacity, reduced physical activity and quality of life. Obesity is likewise a common disease characterized by inflammation, reduced physical activity and quality of life. Targeting both obesity and inflammation may turn out beneficial for patients with COPD and obesity, and this study explore the possibility to reverse a vicious cycle of COPD, lack of physical activity and obesity. The primary objective of the study is to evaluate the effect of Liraglutide 3mg in patients with COPD on patient reported outcomes as measured by the Transition Dyspnea Index. The hypothesis is that Liraglutide 3mg exerts beneficial effects on measures of pulmonary function and quality of life in overweight patients with COPD by reducing body weight and reducing inflammatory activity.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Liraglutide, Placebo
- Keywords
- GLP-1 receptor agonist, Chronic obstructive pulmonary disease, FDG/PET-CT, inflammation, weightloss, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Saxenda, NN2211
Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached.
PlaceboDrug
Matching injection
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Active comparator | Liraglutide injection 3.0 mg daily Receives: Drug: Liraglutide |
| Placebo | Placebo comparator | Placebo, matching injection pen Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition Dyspnea Index (TDI)
The primary objective is to evaluate the effect of Liraglutide 3mg on Transition Dyspnea Index (TDI) after 40 weeks of treatment in subjects with COPD and overweight (BMI>27 kg/m2). A positive value indicates less dyspnea during specified activities
Measured: 40 weeks
Secondary outcomes (19)
6 minutes walking test
Walking distance during a 6-minutes walking test
Measured: 44 weeks
Diffusion capacity of the lung for carbon monoxide (DLCO)
Pulmonary Diffusion Capacity measured by Carbon Monoxide (CO) diffusion capacity test
Measured: 44 weeks
FEV1/FVC
Forced expiratory volume in first second (FEV1)/forced vital capacity (FVC)
Measured: 44 weeks
Total lung capacity (TLC)
Total lung capacity
Measured: 44 weeks
Residual volume (RV)
Residual volume
Measured: 44 weeks
CAT-score
Chronic Obstructive Pulmonary Disease assessment test, a measure of COPD impact on every day life, total score ranges 0-25, a higher score indicates more symptoms
Measured: 44 weeks
SF-36
Short Form (36) Health Survey, which is a Quality of life questionnaire score, subscale scores are calculated according to the SF-36 manual
Measured: 44 weeks
CRP
Inflammation marker, C-reactive protein, higher value indicates more inflammation
Measured: 44 weeks
IL-6
Inflammation marker, Interleukine 6, higher values indicates more inflammation
Measured: 44 weeks
MCP-1
Inflammation marker, Monocyte Chemoattractant Protein-1, higher value indicates more inflammation
Measured: 44 weeks
Maximal standard uptake value (SUV max)
Maximal standard uptake value as measure by FDG-PET/CT scan of the lungs, a higher value indicates more inflammation
Measured: Twice over 44 weeks
Mean standard uptake value (SUV mean)
Mean standard uptake value as measured by FDG-PET/CT scan of the lungs, a higher value indicates more inflammation
Measured: Twice over 44 weeks
Total lesion glycolysis (TLG)
Total lesion glycolysis as measured by FDG-PET/CT, a higher value indicates more inflammation
Measured: Twice over 44 weeks
Body weight
Changes in body weight
Measured: 44 weeks
Number of COPD exacerbations
Mild-moderate exacerbations: Treatment with antibiotics or/and oral prednisolone and Moderate-severe exacerbations: Hospitalization due to pulmonary symptoms.
Measured: 44 weeks
Changes in use of bronchodilator drugs and anti-inflammatory drugs
Defined by an increase in beta2agonists of more than 20 % per week and a change of more than 20 % of dose of anti-inflammatory drugs respectively.
Measured: 44 weeks
Apnea/hypopnea index (AHI)
Apnea/hypopnea index, higher value indicates more apnea/hypopnea episodes
Measured: Twice during 44 weeks
Oxygen desaturation index (ODI)
Oxygen desaturation index, higher values indicate more episodes of desaturation
Measured: Twice during 44 weeks
Epworth score
Epworth sleepiness scale questionnaire, total score is calculated, 0-9: Normal, 10-15: mild to moderate sleep apnea, 16 or more indicate severe sleep apnea
Measured: Twice during 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Jan 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, placebo-controlled, double-blinded, parallel group and two-center trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claus Bogh Juhl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claus Bogh Juhl, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Claus B Juhl, MD PhD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466021
- Sponsor's protocol ID
- U1111-1188-8695
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2018
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dogan ADA, Christensen TQ, Jensen TT, Juhl CB, Hilberg O, Bladbjerg EM, Hess S. FDG-PET/CT-based respiration-gated lung segmentation and quantification of lung inflammation in COPD patients. BMC Res Notes. 2024 Jun 20;17(1):170. doi: 10.1186/s13104-024-06820-w.
PubMed 38902794
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT03466021
- Acronym / sponsor ID
- U1111-1188-8695
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GLP-1 receptor agonist, Chronic obstructive pulmonary disease, FDG/PET-CT, inflammation, weightloss, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Claus Bogh JuhlUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a 44 weeks, prospective, randomized, placebo-controlled, double-blinded, parallel group two-center trial. Forty patients are recruited among the outpatients of the chronic obstructive pulmonary disease (COPD) clinic, Hospital of South West Jutland and Lillebælt Hospital according to the inclusion and exclusion criteria. The patients are randomized to receive liraglutide 3 mg per day (initial dose 0.6 mg, increasing by 0.6 mg weekly until 3 mg is reached) or placebo. At baseline, after four weeks (assessment of the acute effect of liraglutide), 20 weeks, and 40 weeks (assessment of the combined effect of liraglutide and weight loss) and at week 44 (assessment of the weight-loss after discontinuation of liraglutide) the patients are assessed by physical examination, carbon monoxide (CO) diffusion test, pulmonary function test, biomarkers of inflammation (CRP, interleucine-6 (IL-6), monocyte chemitactic protein-1 (MCP-1)), Fluorodeoxyglucose (FDG)/PET-CT scan of the lungs, 6-minute walking test, respiratory polygraphy and validated questionnaires including basic dyspnea index, transition dyspnea index, COPD Assessment Test (CAT)-score, short-form-36 (SF-36) and Epworth Sleepiness Score.
Detailed description
COPD is a common disease characterized by pulmonary inflammation, reduced pulmonary capacity, reduced physical activity and quality of life. Obesity is likewise a common disease characterized by inflammation, reduced physical activity and quality of life. Targeting both obesity and inflammation may turn out beneficial for patients with COPD and obesity, and this study explore the possibility to reverse a vicious cycle of COPD, lack of physical activity and obesity. The primary objective of the study is to evaluate the effect of Liraglutide 3mg in patients with COPD on patient reported outcomes as measured by the Transition Dyspnea Index. The hypothesis is that Liraglutide 3mg exerts beneficial effects on measures of pulmonary function and quality of life in overweight patients with COPD by reducing body weight and reducing inflammatory activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective, randomized, placebo-controlled, double-blinded, parallel group and two-center trial.
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Active comparator | Drug: LiraglutideLiraglutide injection 3.0 mg daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, matching injection pen |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent obtained before any trial-related activities
- COPD as defined by FEV1/FVC<70% after maximal broncho-dilatation and in accordance with the Gold guidelines 2017 (25)
- Previous smoking of ≥ 20 pack-years
- Overweight defined as BMI > 27 kg/m2
- Age 30 - 75 years
Key exclusion criteria (12 listed)
- Chronic treatment with systemic steroids (inhalation steroids allowed)
- Current smokers
- Diabetes mellitus type 1 and type 2 as defined by current or previous treatment with antidiabetic medications of any kind or HbA1c ≥ 48mmol/mol
- Severe hepatic disease (Alanine transferase > 3 x UNL)
- Severe impaired renal function (eGFR < 30ml/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Saxenda, NN2211Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached. | Drug | Liraglutide |
| PlaceboMatching injection | Drug | Placebo |
Primary outcome
Transition Dyspnea Index (TDI)
Time frame: 40 weeks
The primary objective is to evaluate the effect of Liraglutide 3mg on Transition Dyspnea Index (TDI) after 40 weeks of treatment in subjects with COPD and overweight (BMI>27 kg/m2). A positive value indicates less dyspnea during specified activities
19 secondary outcomes
6 minutes walking test
Time frame: 44 weeks
Diffusion capacity of the lung for carbon monoxide (DLCO)
Time frame: 44 weeks
FEV1/FVC
Time frame: 44 weeks
Total lung capacity (TLC)
Time frame: 44 weeks
Residual volume (RV)
Time frame: 44 weeks
CAT-score
Time frame: 44 weeks
SF-36
Time frame: 44 weeks
CRP
Time frame: 44 weeks
IL-6
Time frame: 44 weeks
MCP-1
Time frame: 44 weeks
Maximal standard uptake value (SUV max)
Time frame: Twice over 44 weeks
Mean standard uptake value (SUV mean)
Time frame: Twice over 44 weeks
Total lesion glycolysis (TLG)
Time frame: Twice over 44 weeks
Body weight
Time frame: 44 weeks
Number of COPD exacerbations
Time frame: 44 weeks
Changes in use of bronchodilator drugs and anti-inflammatory drugs
Time frame: 44 weeks
Apnea/hypopnea index (AHI)
Time frame: Twice during 44 weeks
Oxygen desaturation index (ODI)
Time frame: Twice during 44 weeks
Epworth score
Time frame: Twice during 44 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Derived from this study: PubMed 38902794Dogan ADA, Christensen TQ, Jensen TT, Juhl CB, Hilberg O, Bladbjerg EM, Hess S. FDG-PET/CT-based respiration-gated lung segmentation and quantification of lung inflammation in COPD patients. BMC Res Notes. 2024 Jun 20;17(1):170. doi: 10.1186/s13104-024-06820-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus B Juhl, MD PhD principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with Pulmonary Disease, Chronic Obstructive, run by Claus Bogh Juhl at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition Dyspnea Index (TDI) (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03466021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.