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

• ClinicalTrials.gov Identifier: NCT01388920
• Recruitment Status: Terminated
• First Posted: July 7, 2011
• Results First Posted: May 7, 2014
• Last Update Posted: May 1, 2019
• Sponsor: Theratechnologies
• Information provided by (Responsible Party): Theratechnologies

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Tesamorelin	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: September 2011
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tesamorelin 2 mg; Tesamorelin 2 mg/day	Drug: Tesamorelin
Experimental: Tesamorelin 3 mg; Tesamorelin 3 mg/day	Drug: Tesamorelin
Placebo Comparator: Placebo	Drug: Tesamorelin

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change From Baseline in Exercise Capacity at 6 Months [ Time Frame: 6 months ]
2. Change From Baseline in Peripheral Muscle Strength at 6 Months [ Time Frame: 6 months ]
3. Change From Baseline in Patient-reported Outcomes at 6 Months [ Time Frame: 6 months ]
4. Adverse Events [ Time Frame: 6 months ]
   Number and percentage of subjects with adverse events
5. COPD Exacerbations [ Time Frame: 6 months ]
   Frequency and severity of COPD exacerbations
6. Plasma Glucose [ Time Frame: 6 months ]
   Changes from baseline in fasting blood glucose

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Theratechnologies

Investigators

• Principal Investigator: Richard Casaburi, PhD, MD; University of California, Los Angeles

More Information

• Responsible Party: Theratechnologies
• ClinicalTrials.gov Identifier: NCT01388920
• Other Study ID Numbers: TH9507-CTR-1025
• First Posted: July 7, 2011
• Results First Posted: May 7, 2014
• Last Update Posted: May 1, 2019
• Last Verified: April 2014

Keywords provided by Theratechnologies:

COPD; Muscle wasting

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Muscular Atrophy; Wasting Syndrome; Cachexia; Respiratory Tract Diseases; Emaciation; Weight Loss; Body Weight Changes; Body Weight; Metabolic Diseases; Nutrition Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Tesamorelin; Growth Substances; Physiological Effects of Drugs