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

Phase 2

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Placebo; Drug: Tesamorelin

• Registration Number: NCT01388920
• Lead Sponsor: Theratechnologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-07
• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2014-04-04
• Results First Submitted QC: 2014-04-04
• Results First Posted: 2014-05-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Tesamorelin 2 mg	Tesamorelin	Tesamorelin 2 mg/day
Tesamorelin 3 mg	Tesamorelin	Tesamorelin 3 mg/day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change From Baseline in Patient-reported Outcomes at 6 Months	6 months
Plasma Glucose	6 months	Changes from baseline in fasting blood glucose
Change From Baseline in Exercise Capacity at 6 Months	6 months
Change From Baseline in Peripheral Muscle Strength at 6 Months	6 months
Adverse Events	6 months	Number and percentage of subjects with adverse events
COPD Exacerbations	6 months	Frequency and severity of COPD exacerbations