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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tesamorelin
Placebo
Sponsored by
Theratechnologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Muscle wasting

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Tesamorelin 2 mg

    Tesamorelin 3 mg

    Placebo

    Arm Description

    Tesamorelin 2 mg/day

    Tesamorelin 3 mg/day

    Placebo

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 5, 2011
    Last Updated
    March 9, 2022
    Sponsor
    Theratechnologies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01388920
    Brief Title
    Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    The study was terminated based on a non-safety related corporate decision.
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Theratechnologies

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease (COPD)
    Keywords
    COPD, Muscle wasting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tesamorelin 2 mg
    Arm Type
    Experimental
    Arm Description
    Tesamorelin 2 mg/day
    Arm Title
    Tesamorelin 3 mg
    Arm Type
    Experimental
    Arm Description
    Tesamorelin 3 mg/day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Tesamorelin
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Lean Body Mass at 6 Months
    Description
    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
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Exercise Capacity at 6 Months
    Time Frame
    6 months
    Title
    Change From Baseline in Peripheral Muscle Strength at 6 Months
    Time Frame
    6 months
    Title
    Change From Baseline in Patient-reported Outcomes at 6 Months
    Time Frame
    6 months
    Title
    Adverse Events
    Description
    Number and percentage of subjects with adverse events
    Time Frame
    6 months
    Title
    COPD Exacerbations
    Description
    Frequency and severity of COPD exacerbations
    Time Frame
    6 months
    Title
    Plasma Glucose
    Description
    Changes from baseline in fasting blood glucose
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Casaburi, PhD, MD
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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