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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01388920
• Other study ID #: TH9507-CTR-1025
• Status: Terminated
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2022
• Source: Theratechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Muscular Atrophy
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tesamorelin

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Theratechnologies

Outcome

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