Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tesamorelin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Muscle wasting
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Tesamorelin 2 mg
Tesamorelin 3 mg
Placebo
Arm Description
Tesamorelin 2 mg/day
Tesamorelin 3 mg/day
Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Number and percentage of subjects with adverse events
COPD Exacerbations
Frequency and severity of COPD exacerbations
Plasma Glucose
Changes from baseline in fasting blood glucose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01388920
Brief Title
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated based on a non-safety related corporate decision.
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theratechnologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Muscle wasting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tesamorelin 2 mg
Arm Type
Experimental
Arm Description
Tesamorelin 2 mg/day
Arm Title
Tesamorelin 3 mg
Arm Type
Experimental
Arm Description
Tesamorelin 3 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tesamorelin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Lean Body Mass at 6 Months
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Exercise Capacity at 6 Months
Time Frame
6 months
Title
Change From Baseline in Peripheral Muscle Strength at 6 Months
Time Frame
6 months
Title
Change From Baseline in Patient-reported Outcomes at 6 Months
Time Frame
6 months
Title
Adverse Events
Description
Number and percentage of subjects with adverse events
Time Frame
6 months
Title
COPD Exacerbations
Description
Frequency and severity of COPD exacerbations
Time Frame
6 months
Title
Plasma Glucose
Description
Changes from baseline in fasting blood glucose
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Casaburi, PhD, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
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