DRUG
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
Status
Terminated
Phase
Phase 2
Enrollment
3
Locations
0
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Placebo
Timeline
From registration to results.
First posted
Jul 7, 2011
Study start
Sep 2011
Primary completion
Dec 2011
Study completion
Dec 2011
Results posted
May 7, 2014
Registry updated
Mar 18, 2022
Outcomes
What the study measures.
Primary outcomes
Change From Baseline in Lean Body Mass at 6 Months
Time frame · 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 outcomes
Change From Baseline in Exercise Capacity at 6 Months
Time frame · 6 months
Change From Baseline in Peripheral Muscle Strength at 6 Months
Time frame · 6 months
Change From Baseline in Patient-reported Outcomes at 6 Months
Time frame · 6 months
Adverse Events
Time frame · 6 months
Number and percentage of subjects with adverse events
COPD Exacerbations
Time frame · 6 months
Frequency and severity of COPD exacerbations
Plasma Glucose
Time frame · 6 months
Changes from baseline in fasting blood glucose
Eligibility
Who can take part.
- Minimum age
- 40 Years
- Maximum age
- 75 Years
- Sex
- ALL
- 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
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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