Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Doses of Tesamorelin in Stable Ambulatory COPD Subjects With Muscle Wasting|
- Lean body mass [ Time Frame: 6 months ] [ Designated as safety issue: No ]The primary objective of the study is to evaluate the effect of tesamorelin on lean body mass by DXA scan
- Exercise capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Peripheral muscle strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient-reported outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Number and percentage of subjects with adverse events
- COPD exacerbations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Frequency and severity of COPD exacerbations
- Plasma glucose [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Changes from baseline in fasting blood glucose
|Study Start Date:||September 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Tesamorelin 2 mg
Tesamorelin 2 mg/day
Experimental: Tesamorelin 3 mg
Tesamorelin 3 mg/day
|Placebo Comparator: Placebo|