Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD, Muscle wasting
Brief summary
A significant proportion of COPD subjects experience muscle wasting, which has been associated with increased morbidity, impaired physical functioning, and a poor quality of life. Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular, weakness of peripheral muscles has been reported to play an important role in the reduced functional capacity and impaired exercise performance. The primary objective of this study is to investigate the effect of tesamorelin, in conjunction with exercise training, on lean body mass measured by dual energy x-ray absorptiometry (DXA) scan.
Interventions
DRUGTesamorelin
DRUGPlacebo
Sponsors
Theratechnologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Requirement for long-term oxygen therapy (\> 12 hours of oxygen per day) * Critical illness or co-morbid conditions that may interfere with study conduct or endpoint measurements * Use of agents known to increase lean body mass within 3 months prior to screening * Hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lean Body Mass at 6 Months | 6 months | The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Peripheral Muscle Strength at 6 Months | 6 months | — |
| Change From Baseline in Patient-reported Outcomes at 6 Months | 6 months | — |
| Change From Baseline in Exercise Capacity at 6 Months | 6 months | — |
| COPD Exacerbations | 6 months | Frequency and severity of COPD exacerbations |
| Plasma Glucose | 6 months | Changes from baseline in fasting blood glucose |
| Adverse Events | 6 months | Number and percentage of subjects with adverse events |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tesamorelin 2 mg Tesamorelin 2 mg/day for 6 months | 1 |
| Tesamorelin 3 mg Tesamorelin 3 mg/day for 6 months | 1 |
| Placebo Placebo for 6 months | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Tesamorelin 2 mg | Tesamorelin 3 mg | Total |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 0 | 51 years STANDARD_DEVIATION 0 | 55 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 0 |
Outcome results
Primary
Change From Baseline in Lean Body Mass at 6 Months
The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan
Time frame: 6 months
Population: The primary objective of the study was the change in lean body mass between baseline and Month 6. However, the study was halted approximately 1 month after patient enrollment.
Secondary
Adverse Events
Number and percentage of subjects with adverse events
Time frame: 6 months
Secondary
Change From Baseline in Exercise Capacity at 6 Months
Time frame: 6 months
Secondary
Change From Baseline in Patient-reported Outcomes at 6 Months
Time frame: 6 months
Secondary
Change From Baseline in Peripheral Muscle Strength at 6 Months
Time frame: 6 months
Secondary
COPD Exacerbations
Frequency and severity of COPD exacerbations
Time frame: 6 months
Secondary
Plasma Glucose
Changes from baseline in fasting blood glucose
Time frame: 6 months