Chronic Obstructive Pulmonary DiseaseNCT01750489
Muscle Dysfunction in Patients With Chronic Obstructive Lung Disease (COPD): the Role of Sympathetic Activation
A study testing non-invasive ventilation (NIV) in people with Chronic Obstructive Pulmonary Disease, run by University Medical Center Goettingen at 1 site in Germany.
Trial summary
The objective of the project is to better understand the causes of exercise limitation, dyspnea and neurohumoral activation in patients with COPD. In particular, the investigators aim to explore the mutual interaction of neurohumoral activation and exercise limitation thereby focussing on differential effects of the… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- non-invasive ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Nov 2012
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD II or III according to the GOLD guidelines
- FEV1 of less than 60% of the predicted value
- RV/TLC > 45%
- Optimal stable medication according to the GOLD guidelines for at least 2 weeks
- The last exacerbation must not be more recent than three weeks
- Stable sinus rhythm
- The subgroup on NIV should be stable on NIV for > 1 month
Who cannot join
- not willing or unable to sign the informed consent before the study begins
- Age under 30 or over 80 years
- paO2< 55 mmHg or PaCO2 > 45 mmHg on arterial blood gas analysis (For patients on NIV, PaCO2 values of up to 55 mmHg are acceptable.)
- Treatment with drugs having direct sympathomimetic activity (e.g. theophylline, moxonidine, clonidine)
- Oral medication with beta2 sympathomimetics (therapy with long-acting inhaled beta2 sympathomimetics is permitted)
- History of sleep apnoea or documented evidence of > 15 episodes of apneas and/or hypopnea per hour during sleep. An episode of apnea is defined as the cessation of inspiratory airflow for 10 s or more. Hypopnea is defined as a reduction in airflow (> 50%) lasting for more than 10 s in comparison with the maximum airflow recorded during the preceding breathing cycle.
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- Myocardial infarction (MI) or a coronary revascularization procedure within the previous 2 calendar months
- Clinically evident polyneuropathy
- Diabetes mellitus necessitating any pharmacologic therapy
- Severe (i.e., life-limiting) concomitant disease, including life-threatening malignancy (cancer likely to reduce life expectancy to less than 5 years), acquired immune deficiency syndrome, or any other life-threatening disease.
- Diuretics should not be taken before measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skeletal and Respiratory Muscle Dysfunction in Patients With COPD: the Role of Sympathetic Activation
The objective of the project is to better understand the causes of exercise limitation, dyspnea and neurohumoral activation in patients with COPD. In particular, the investigators aim to explore the mutual interaction of neurohumoral activation and exercise limitation thereby focussing on differential effects of the peripheral muscle and the diaphragm.
Eventually the findings might influence treatment modalities. If sympathetic activation contributes to exercise limitation then drugs influencing the autonomic nervous system would be a reasonable therapeutic concept. If a reduction of sympathetic activity due to an alteration of the ergoreflex can be achieved by non-invasive ventilation this would help to improve dyspnea and exercise capacity.
Read the detailed description
Our aim is to investigate whether reduced exercise capacity, increased respiratory drive and dyspnoea are linked to heightened sympathetic activation at rest and during exercise in patients with COPD. Furthermore, the effect of unloading the respiratory muscles by using non-invasive ventilation (NIV) will be assessed. Fifteen stable COPD patients without NIV will be matched to 15 healthy control subjects (with sufficient microneurography recording). Furthermore COPD patients on regular NIV will be studied. Each participant will undergo symptom limited bicycle exercise and a handgrip protocol. Microneurography will be used to quantify sympathetic activity by the transcutaneous registration of postganglionic sympathetic efferents.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- non-invasive ventilation (NIV)
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilation (NIV)Device
| Study group | Role | What they receive |
|---|---|---|
| COPD | No intervention | Not described |
| COPD with non-invasive ventilation (NIV) | Experimental | Starting non-invasive ventilation with the patient's own device during registration of MSNA. Receives: Device: non-invasive ventilation (NIV) |
| Healthy control subjects | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle sympathetic nerve activity (MSNA)
In a 90 minute microneurographic measurement muscle sympathetic nerve activity is assessed.
Measured: 90 minutes
Arterial stiffness
Measured: 90 min
Secondary outcomes (1)
VE/VCO2
Measured: During 8-15 minutes bicycle exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2012
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.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Raupach, University Medical Center Goettingen
- Investigators
- Stefan Andreas, Professor, Principal investigator, Universitaetsmedizin Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750489
- Sponsor's protocol ID
- RA1937/1-1
- Status last verified
- May 2014
- First submitted
- 9 Dec 2012
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Raupach T, Bahr F, Herrmann P, Luethje L, Heusser K, Hasenfuss G, Bernardi L, Andreas S. Slow breathing reduces sympathoexcitation in COPD. Eur Respir J. 2008 Aug;32(2):387-92. doi: 10.1183/09031936.00109607. Epub 2008 Apr 2.
PubMed 18385175
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal and Respiratory Muscle Dysfunction in Patients With COPD: the Role of Sympathetic Activation
- ClinicalTrials.gov ID
- NCT01750489
- Acronym / sponsor ID
- RA1937/1-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- First posted
- 17 Dec 2012 (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.
The objective of the project is to better understand the causes of exercise limitation, dyspnea and neurohumoral activation in patients with COPD. In particular, the investigators aim to explore the mutual interaction of neurohumoral activation and exercise limitation thereby focussing on differential effects of the peripheral muscle and the diaphragm.
Eventually the findings might influence treatment modalities. If sympathetic activation contributes to exercise limitation then drugs influencing the autonomic nervous system would be a reasonable therapeutic concept. If a reduction of sympathetic activity due to an alteration of the ergoreflex can be achieved by non-invasive ventilation this would help to improve dyspnea and exercise capacity.
Detailed description
Our aim is to investigate whether reduced exercise capacity, increased respiratory drive and dyspnoea are linked to heightened sympathetic activation at rest and during exercise in patients with COPD. Furthermore, the effect of unloading the respiratory muscles by using non-invasive ventilation (NIV) will be assessed. Fifteen stable COPD patients without NIV will be matched to 15 healthy control subjects (with sufficient microneurography recording). Furthermore COPD patients on regular NIV will be studied. Each participant will undergo symptom limited bicycle exercise and a handgrip protocol. Microneurography will be used to quantify sympathetic activity by the transcutaneous registration of postganglionic sympathetic efferents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD | No intervention | – |
| COPD with non-invasive ventilation (NIV) | Experimental | Device: non-invasive ventilation (NIV)Starting non-invasive ventilation with the patient's own device during registration of MSNA. |
| Healthy control subjects | No intervention | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of COPD II or III according to the GOLD guidelines
- FEV1 of less than 60% of the predicted value
- RV/TLC > 45%
- Optimal stable medication according to the GOLD guidelines for at least 2 weeks
- The last exacerbation must not be more recent than three weeks
Key exclusion criteria (11 listed)
- not willing or unable to sign the informed consent before the study begins
- Age under 30 or over 80 years
- paO2< 55 mmHg or PaCO2 > 45 mmHg on arterial blood gas analysis (For patients on NIV, PaCO2 values of up to 55 mmHg are acceptable.)
- Treatment with drugs having direct sympathomimetic activity (e.g. theophylline, moxonidine, clonidine)
- Oral medication with beta2 sympathomimetics (therapy with long-acting inhaled beta2 sympathomimetics is permitted)
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 |
|---|---|---|
| non-invasive ventilation (NIV) | Device | COPD with non-invasive ventilation (NIV) |
Primary outcome
muscle sympathetic nerve activity (MSNA)
Time frame: 90 minutes
In a 90 minute microneurographic measurement muscle sympathetic nerve activity is assessed.
Arterial stiffness
Time frame: 90 min
1 secondary outcome
VE/VCO2
Time frame: During 8-15 minutes bicycle exercise
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 12 May 2014.
- Background: PubMed 18385175Raupach T, Bahr F, Herrmann P, Luethje L, Heusser K, Hasenfuss G, Bernardi L, Andreas S. Slow breathing reduces sympathoexcitation in COPD. Eur Respir J. 2008 Aug;32(2):387-92. doi: 10.1183/09031936.00109607. Epub 2008 Apr 2.
- Information about research facilityLink provided by the sponsor.
- Information about research facilityLink provided by the sponsor.
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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.
Stefan Andreas, Professor principal investigator
Universitaetsmedizin Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive ventilation (NIV) in people with Chronic Obstructive Pulmonary Disease, run by University Medical Center Goettingen at 1 site in Germany.
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 7 inclusion and 11 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 12 May 2014. 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 Germany. 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. 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?
muscle sympathetic nerve activity (MSNA) (time frame: 90 minutes). The study lists 2 primary outcomes in all. 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 NCT01750489, 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 12 May 2014.