Chronic Obstructive Pulmonary DiseaseNCT00458419
Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
A study testing intravenous injection of normal saline or naloxone in people with Chronic Obstructive Pulmonary Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- intravenous injection of normal saline or naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- Ability to exercise
- Ability to computer mouse to provide ratings
- > 10 pack-years smoking
- Baseline dyspnea index < 9
Who cannot join
- Clinically significant comorbidities
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
About this study
Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). The initial five visits include familiarization and validation of a computerized system for patients to report dyspnea and leg discomfort continuously during exercise testing.
At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5 minutes prior to exercise in a double-blinded design. The primary outcome is the slope of oxygen consumption - dyspnea.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- naloxone versus placebo, intravenous injection of normal saline or naloxone
- Keywords
- dyspnea; leg discomfort; exercise duration
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naloxone versus placeboDrug
10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
intravenous injection of normal saline or naloxoneDrug
Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| A: naloxone; B: normal saline | Placebo comparator | Arm A: IV naloxone Arm B: IV normal saline Receives: Drug: naloxone versus placebo; Drug: intravenous injection of normal saline or naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of oxygen consumption - dyspnea during treadmill exercise.
Measured: throughout exercise
Secondary outcomes (2)
Exercise duration
Measured: 10-14 minutes
Peak ratings of breathlessness
Measured: at end of exercsie - 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startSep 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Doanld A Mahler, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458419
- Sponsor's protocol ID
- 17355
- Status last verified
- Oct 2007
- First submitted
- 8 Apr 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahler DA, Murray JA, Waterman LA, Ward J, Kraemer WJ, Zhang X, Baird JC. Endogenous opioids modify dyspnoea during treadmill exercise in patients with COPD. Eur Respir J. 2009 Apr;33(4):771-7. doi: 10.1183/09031936.00145208. Epub 2009 Feb 12.
PubMed 19213787
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00458419
- Acronym / sponsor ID
- 17355
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- dyspnea; leg discomfort; exercise duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- May 2007 (actual)
- First posted
- 10 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). The initial five visits include familiarization and validation of a computerized system for patients to report dyspnea and leg discomfort continuously during exercise testing.
At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5 minutes prior to exercise in a double-blinded design. The primary outcome is the slope of oxygen consumption - dyspnea.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A: naloxone; B: normal saline | Placebo comparator | Drug: naloxone versus placebo, Drug: intravenous injection of normal saline or naloxoneArm A: IV naloxone Arm B: IV normal saline |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of COPD
- Ability to exercise
- Ability to computer mouse to provide ratings
- > 10 pack-years smoking
- Baseline dyspnea index < 9
Key exclusion criteria (1 listed)
- Clinically significant comorbidities
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 |
|---|---|---|
| naloxone versus placebo10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits | Drug | A: naloxone; B: normal saline |
| intravenous injection of normal saline or naloxoneArm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline | Drug | A: naloxone; B: normal saline |
Primary outcome
Slope of oxygen consumption - dyspnea during treadmill exercise.
Time frame: throughout exercise
2 secondary outcomes
Exercise duration
Time frame: 10-14 minutes
Peak ratings of breathlessness
Time frame: at end of exercsie - 10-15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
- Derived from this study: PubMed 19213787Mahler DA, Murray JA, Waterman LA, Ward J, Kraemer WJ, Zhang X, Baird JC. Endogenous opioids modify dyspnoea during treadmill exercise in patients with COPD. Eur Respir J. 2009 Apr;33(4):771-7. doi: 10.1183/09031936.00145208. Epub 2009 Feb 12.
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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.
Doanld A Mahler, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous injection of normal saline or naloxone in people with Chronic Obstructive Pulmonary Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Slope of oxygen consumption - dyspnea during treadmill exercise. (time frame: throughout exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458419, which also lists 1 linked publication.
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 2 Nov 2007.