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

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. Identifier: NCT01388920
Recruitment Status : Terminated (The study was terminated based on a non-safety related corporate decision.)
First Posted : July 7, 2011
Results First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Information provided by (Responsible Party):

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 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

Resource links provided by the National Library of Medicine

Drug Information available for: Tesamorelin

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01388920

Sponsors and Collaborators
Principal Investigator: Richard Casaburi, PhD, MD University of California, Los Angeles

Responsible Party: Theratechnologies Identifier: NCT01388920     History of Changes
Other Study ID Numbers: TH9507-CTR-1025
First Posted: July 7, 2011    Key Record Dates
Results First Posted: May 7, 2014
Last Update Posted: May 7, 2014
Last Verified: April 2014

Keywords provided by Theratechnologies:
Muscle wasting

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