Effects of Liraglutide in Chronic Obstructive Pulmonary Disease

What Was Tested

The trial (phase 4) is built around Liraglutide.

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.

It had two arms (groups): Liraglutide (active comparator) and Placebo (placebo comparator).

Placebo, matching injection pen.

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Informed consent obtained before any trial-related activities. Previous smoking of ≥ 20 pack-years. Overweight defined as BMI \> 27 kg/m2. Age 30 - 75 years.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: chronic treatment with systemic steroids (inhalation steroids allowed); current smokers; severe hepatic disease (alanine transferase \> 3 x unl).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2018-01-01 with completion listed for 2020-05-31.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Transition Dyspnea Index (TDI) (time frame: 40 weeks).

It also tracked 19 secondary outcomes, for example 6 minutes walking test, Diffusion capacity of the lung for carbon monoxide (DLCO), FEV1/FVC, Total lung capacity (TLC), Residual volume (RV) and CAT-score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.