parallel randomized trial

NCT03466021

Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease.

Design

Randomized: 40
Start year: 2018
Treatment: 40 weeks, follow-up 44 weeks
Countries: Denmark (2 sites)
Sponsor: Claus Bogh Juhl (mixed)
Eligibility: age 40 to 75, BMI above 27, COPD with FEV1/FVC below 70 percent, former smokers, diabetes excluded

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	lifestyle: not reported	20	19
A2	Placebo Placebo	lifestyle: not reported	20	20

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Liraglutide 3.0 mg subcutaneous once daily A1	Placebo A2
age	mean (years)	64.0	65.3
age	sd (years)	8.4	6.7
ahi	mean (events/h)	21.1	17.6
ahi	sd (events/h)	13.9	12.2
bmi	mean (kg/m2)	35.1	36.6
bmi	sd (kg/m2)	3.7	5.6
female	n	7	9
female	percent	35.0	45.0
weight	mean (kg)	104.4	102.5
weight	sd (kg)	13.6	18.0

16 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

SF-36 physical component summary change (3 lines; O24A)

Week	Arm	Statistic	Estimate	Detail
40	A1	final	39.4 points	not stated; other; R0008744:Table 4
40	A1 vs A2	md	0.51 points	not stated; other; R0003806:Table 3
40	A2	final	41.3 points	not stated; other; R0008744:Table 4

Physical functioning (any instrument) (4 lines; O24B)

Week	Arm	Statistic	Estimate	Detail
40	A1	final	35.6 points	not stated; other; R0008744:Table 4
40	A1 vs A2	md	-11.2 points	not stated; other; R0003806:Table 3
40	A1 vs A2	md	-4.3 points	not stated; other; R0003806:Table 3
40	A2	final	62.1 points	not stated; other; R0008744:Table 4

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	Detail
20	A1 vs A2	md	-0.18 points	not stated; full analysis; R0006978:Table 2
40	A1 vs A2	md	-3.94 points	not stated; full analysis; R0006978:Table 2
44	A1 vs A2	md	-0.68 points	not stated; full analysis; R0006978:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 19	not stated; full analysis; R0006978:Figure 1
A2	events	1 / 20	not stated; full analysis; pancreatitis; R0006978:Figure 1
A2	events	1 / 20	not stated; full analysis; suspected pulmonary cancer; R0006978:Figure 1

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 19	not stated; full analysis; R0006978:Figure 1
	A2	events				0 / 20	not stated; full analysis; R0006978:Figure 1

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 20	not stated; randomized; pancreatitis; R0006978:Figure 1