Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT01388920
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
A Phase 2 study testing Tesamorelin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Theratechnologies.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tesamorelin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
- Being tested
- Tesamorelin, Placebo
- Keywords
- COPD, Muscle wasting
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesamorelinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tesamorelin 2 mg | Experimental | Tesamorelin 2 mg/day Receives: Drug: Tesamorelin |
| Tesamorelin 3 mg | Experimental | Tesamorelin 3 mg/day Receives: Drug: Tesamorelin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (6)
Change From Baseline in Exercise Capacity at 6 Months
Measured: 6 months
Change From Baseline in Peripheral Muscle Strength at 6 Months
Measured: 6 months
Change From Baseline in Patient-reported Outcomes at 6 Months
Measured: 6 months
Adverse Events
Number and percentage of subjects with adverse events
Measured: 6 months
COPD Exacerbations
Frequency and severity of COPD exacerbations
Measured: 6 months
Plasma Glucose
Changes from baseline in fasting blood glucose
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: The study was terminated based on a non-safety related corporate decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theratechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Casaburi, PhD, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388920
- Sponsor's protocol ID
- TH9507-CTR-1025
- Status last verified
- Mar 2022
- First submitted
- 5 Jul 2011
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01388920
- Acronym / sponsor ID
- TH9507-CTR-1025
- Keywords
- COPD, Muscle wasting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based on a non-safety related corporate decision.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- TheratechnologiesIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tesamorelin 2 mg | Experimental | Drug: TesamorelinTesamorelin 2 mg/day |
| Tesamorelin 3 mg | Experimental | Drug: TesamorelinTesamorelin 3 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tesamorelin | Drug | Tesamorelin 2 mg, Tesamorelin 3 mg |
| Placebo | Drug | Placebo |
Primary outcome
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
6 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
COPD Exacerbations
Time frame: 6 months
Plasma Glucose
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Casaburi, PhD, MD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesamorelin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Theratechnologies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Lean Body Mass at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.