NCT01750489

Brief 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 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

December 9, 2012

Last Update Submit

May 9, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

  • muscle sympathetic nerve activity (MSNA)

    In a 90 minute microneurographic measurement muscle sympathetic nerve activity is assessed.

    90 minutes

  • Arterial stiffness

    90 min

Secondary Outcomes (1)

  • VE/VCO2

    During 8-15 minutes bicycle exercise

Study Arms (3)

COPD

NO INTERVENTION

COPD with non-invasive ventilation (NIV)

EXPERIMENTAL

Starting non-invasive ventilation with the patient's own device during registration of MSNA.

Device: non-invasive ventilation (NIV)

Healthy control subjects

NO INTERVENTION

Interventions

non-invasive ventilation (NIV)DEVICE
COPD with non-invasive ventilation (NIV)

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaetsmedizin Goettingen

Göttingen, 37075, Germany

Location

Related Publications (1)

  • 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.

    PMID: 18385175BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Stefan Andreas, Professor

    Universitaetsmedizin Goettingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 9, 2012

First Posted

December 17, 2012

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

DE(1)