We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(The study was terminated based on a non-safety related corporate decision.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388920
First Posted: July 7, 2011
Last Update Posted: May 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theratechnologies
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Tesamorelin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Theratechnologies:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 3
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tesamorelin 2 mg
Tesamorelin 2 mg/day
Drug: Tesamorelin
Experimental: Tesamorelin 3 mg
Tesamorelin 3 mg/day
Drug: Tesamorelin
Placebo Comparator: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388920


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     History of Changes
Other Study ID Numbers: TH9507-CTR-1025
First Submitted: July 5, 2011
First Posted: July 7, 2011
Results First Submitted: April 4, 2014
Results First Posted: May 7, 2014
Last Update Posted: May 7, 2014
Last Verified: April 2014

Keywords provided by Theratechnologies:
COPD
Muscle wasting

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cachexia
Wasting Syndrome
Muscular Atrophy
Respiratory Tract Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Growth Hormone-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs


To Top