Chronic Obstructive Pulmonary DiseaseComfortCOPDNCT02585752
A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b
A study testing Noninvasive ventilation in people with Chronic Obstructive Pulmonary Disease, run by ResMed at 1 site in Germany.
Trial summary
Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP) are well known problems in COPD patients with acute and chronic respiratory failure. Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of major importance since in some circumstances… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Noninvasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2015to 24 Nov 2017
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel
- Signed informed consent
- Moderate to severe COPD patients (FEV1/FVC ratio <70% and FEV1 < 50% pred) with chronic hypercapnic respiratory failure (PaCO2 >45 mmHg)
- Currently using NIV
Who cannot join
- Acute exacerbation of COPD, acute respiratory failure (ph < 7,35 and/or respiratory rate >30/min)
- Unstable heart failure
- Cardiac failure with dehydration
- Pregnancy/breastfeeding women
- Pneumothorax/-mediastinum
- Increased risk of pneumothorax, pneumomediastinum or venous air embolism
- In the opinion of the investigator, the patient is unsuitable for the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP) are well known problems in COPD patients with acute and chronic respiratory failure. Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of major importance since in some circumstances (e.g. during exercise or during exacerbations) it can significantly increase respiratory workload of COPD patients. Extrinsic PEEP applied during both, invasive and noninvasive ventilation is used to overcome intrinsic PEEP and therefore to avoid or reduce dynamic hyperinflation.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Noninvasive ventilation
- 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.
Noninvasive ventilationDevice
Expiratory pressure modulation
| Study group | Role | What they receive |
|---|---|---|
| Single centre, single arm | Experimental | Noninvasive ventilation with expiratory modulation. Assessment of comfort and blood gases. Receives: Device: Noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Subjective rating of comfort during expiration
Measured: 1 day
Secondary outcomes (5)
Minute ventilation
Volume of inhaled air in one minute (L/min)
Measured: 1 day
Respiratory rate
Number of breaths per minute (breaths/min)
Measured: 1 day
Tidal volume
Volume of air that is inhaled or exhaled during normal breathing (mL)
Measured: 1 day
CO2 transcutaneous (tcCO2)
Arterial carbon dioxide partial pressure (mm Hg)
Measured: 1 day
pO2 arterial (paO2)
Arterial oxygen partial pressure (mm Hg)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion30 Sep 2017
- Study completion24 Nov 2017
Why it stopped: Low recruitment
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 ResMedThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Dreher, MD, Principal investigator, Universitätsklinikum Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585752
- Sponsor's protocol ID
- 14-177 / AA-CmfCOPD-02
- Acronym
- ComfortCOPD
- Status last verified
- Apr 2018
- First submitted
- 20 Oct 2015
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Cornelissen CG, Müller T, Schmitz S, Dreher M. Nichtinvasive Beatmung: Patientenkomfort und Sicherheit einer Modulation des expiratorischen Flusses. Pneumologie 2018; 72(S01), S11
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b
- ClinicalTrials.gov ID
- NCT02585752
- Acronym / sponsor ID
- ComfortCOPD / 14-177 / AA-CmfCOPD-02
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 24 Nov 2017 (actual)
- First posted
- 23 Oct 2015 (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.
Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP) are well known problems in COPD patients with acute and chronic respiratory failure. Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of major importance since in some circumstances (e.g. during exercise or during exacerbations) it can significantly increase respiratory workload of COPD patients. Extrinsic PEEP applied during both, invasive and noninvasive ventilation is used to overcome intrinsic PEEP and therefore to avoid or reduce dynamic hyperinflation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single centre, single arm | Experimental | Device: Noninvasive ventilationNoninvasive ventilation with expiratory modulation. Assessment of comfort and blood gases. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel
- Signed informed consent
- Moderate to severe COPD patients (FEV1/FVC ratio <70% and FEV1 < 50% pred) with chronic hypercapnic respiratory failure (PaCO2 >45 mmHg)
- Currently using NIV
Key exclusion criteria (7 listed)
- Acute exacerbation of COPD, acute respiratory failure (ph < 7,35 and/or respiratory rate >30/min)
- Unstable heart failure
- Cardiac failure with dehydration
- Pregnancy/breastfeeding women
- Pneumothorax/-mediastinum
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 |
|---|---|---|
| Noninvasive ventilationExpiratory pressure modulation | Device | Single centre, single arm |
Primary outcome
Visual Analogue Scale
Time frame: 1 day
Subjective rating of comfort during expiration
5 secondary outcomes
Minute ventilation
Time frame: 1 day
Respiratory rate
Time frame: 1 day
Tidal volume
Time frame: 1 day
CO2 transcutaneous (tcCO2)
Time frame: 1 day
pO2 arterial (paO2)
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- BackgroundCornelissen CG, Müller T, Schmitz S, Dreher M. Nichtinvasive Beatmung: Patientenkomfort und Sicherheit einer Modulation des expiratorischen Flusses. Pneumologie 2018; 72(S01), S11
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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.
Michael Dreher, MD principal investigator
Universitätsklinikum Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation in people with Chronic Obstructive Pulmonary Disease, run by ResMed 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 4 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 23 Apr 2018. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Visual Analogue Scale (time frame: 1 day). 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 NCT02585752, 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 23 Apr 2018.