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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT01388920 (opens ClinicalTrials.gov in a new tab)Other idTH9507-CTR-1025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
3 participants (actual)
Sponsor
Theratechnologies · Industry
Design
Randomized · Quadruple masking
Countries
Not stated
Start
Sept 2011
Primary completion
Dec 2011
Completion
Dec 2011
First posted
7 Jul 2011 (estimated)
Last update posted
18 Mar 2022
Conditions
Chronic Obstructive Pulmonary Disease (COPD)

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012
  1. Ph 2

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

    NCT01388920

    Sept 2011 to Dec 2011

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TesamorelinDrug
  • PlaceboDrug

Arms3

  • Experimental

    Tesamorelin 2 mg

    Tesamorelin 2 mg/day

  • Experimental

    Tesamorelin 3 mg

    Tesamorelin 3 mg/day

  • Placebo comparator

    Placebo

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Lean Body Mass at 6 Months

    Time frame · 6 months

    Registry 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

Secondary outcomes(6)

  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

    Registry description

    Number and percentage of subjects with adverse events

  5. COPD Exacerbations

    Time frame · 6 months

    Registry description

    Frequency and severity of COPD exacerbations

  6. Plasma Glucose

    Time frame · 6 months

    Registry description

    Changes from baseline in fasting blood glucose

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 6 months

Change From Baseline in Lean Body Mass at 6 Months

GroupValue
Tesamorelin 2 mgnot posted
Tesamorelin 3 mgnot posted
Placebonot posted
Secondary and other outcome results(6)
Secondary outcome· 6 months

Change From Baseline in Exercise Capacity at 6 Months

GroupValue
Secondary outcome· 6 months

Change From Baseline in Peripheral Muscle Strength at 6 Months

GroupValue
Secondary outcome· 6 months

Change From Baseline in Patient-reported Outcomes at 6 Months

GroupValue
Secondary outcome· 6 months

Adverse Events

GroupValue
Secondary outcome· 6 months

COPD Exacerbations

GroupValue
Secondary outcome· 6 months

Plasma Glucose

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Tesamorelin 2 mgTesamorelin 2 mg/day for 6 months–0 / 10 / 1
Tesamorelin 3 mgTesamorelin 3 mg/day for 6 months–0 / 10 / 1
PlaceboPlacebo for 6 months–0 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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