Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting

What Was Tested

The trial (phase 2) is built around Tesamorelin for muscle disease (myopathy).

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 3 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female subjects aged 40-75 years (y) inclusive. Documented diagnosis of moderate to very severe COPD (GOLD stage 2, 3, or 4). Stable COPD (i.e., no exacerbation) for at least 6 weeks prior to screening. Able to participate in a supervised exercise training program. Evidence of muscle wasting.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: participation in a pulmonary rehabilitation program or in any supervised exercise program during the 4 months prior to screening; more than 4 exacerbations in the year prior to screening; life-threatening exacerbation in the year prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Tesamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the muscle disease (myopathy) participants stayed in one arm throughout.

Neither the muscle disease (myopathy) participants nor the staff measuring them knew who was on Tesamorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-09 with completion listed for 2011-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Lean Body Mass at 6 Months (time frame: 6 months).

It also tracked 6 secondary outcomes, for example Change From Baseline in Exercise Capacity at 6 Months, Change From Baseline in Peripheral Muscle Strength at 6 Months, Change From Baseline in Patient-reported Outcomes at 6 Months, Adverse Events, COPD Exacerbations and Plasma Glucose.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin in 3 people with muscle disease (myopathy).

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Tesamorelin compound page, Muscle disease (myopathy) research.