Current partner codePEPTIDESDE
NCT01388920·Phase 2·INTERVENTIONAL

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

Status

Terminated

Phase

Phase 2

Enrollment

3

Locations

0

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Tesamorelin

DRUG

Placebo

Timeline

From registration to results.

  1. First posted

    Jul 7, 2011

  2. Study start

    Sep 2011

  3. Primary completion

    Dec 2011

  4. Study completion

    Dec 2011

  5. Results posted

    May 7, 2014

  6. Registry updated

    Mar 18, 2022

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
75 Years
Sex
ALL
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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tesamorelin.

Related PeptideStat pages

Put the record in context.

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