COPD ExacerbationNCT03025425
Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD
A study testing Trilogy 100 ® (Philips Respironics) in people with COPD Exacerbation and Dyspnea, run by Tampere University Hospital at 1 site in Finland.
Trial summary
An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure. Subjects are recruited from the local respiratory ward. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Dyspnea
- What is being tested?
- Trilogy 100 ® (Philips Respironics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2017to 1 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a previous diagnosis of COPD
- hospitalized due to acute exacerbation of COPD
- at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)
- no acute hypoventilation (pH ≥ 7.35 and PCO2 ≤ 6.0 kPa)
- able to understand the study and to give informed consent
Who cannot join
- unable to participate and use MPV due to e.g. delirium or lack of co-operation
- acute hypoventilation (pH < 7.35 or PCO2 > 6.0 kPa)
- acute need for ventilatory support
- the cause of the dyspnea can be successfully treated
- unable to give informed consent
- a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been treated on a long-term basis also at home
Trial locations and contacts
1 site in 1 country.
Finland1 site
Dpt of Respiratory Medicine, Tampere University Hospital
Tampere, 33520
About this study
Official title: Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency
An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure. Subjects are recruited from the local respiratory ward. The main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.
- Conditions
- COPD Exacerbation, Dyspnea
- Being tested
- Trilogy 100 ® (Philips Respironics)
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trilogy 100 ® (Philips Respironics)Device
Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).
| Study group | Role | What they receive |
|---|---|---|
| MPV-arm | Experimental | Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea. Receives: Device: Trilogy 100 ® (Philips Respironics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dyspnea after initial period of using MPV
Change in dyspnea after initial period of using MPV
Measured: 5-60 min
Secondary outcomes (4)
Change in dyspnea after 24 hours of using MPV
Change in dyspnea after 24 hours of using MPV
Measured: 24 hours
Proportion of subjects having side-effects or not being compliant with MPV
Proportion of subjects having side-effects or not being compliant with MPV
Measured: 24 hours
Proportion of subjects gaining from MPV
Proportion of subjects gaining from MPV
Measured: 24 hours
Proportion of subjects willing to continue on MPV after the intervention
Proportion of subjects willing to continue on MPV after the intervention
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Why it stopped: Difficulty in finding suitable patients
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 COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauri Lehtimäki, Tampere University Hospital
- Investigators
- Lauri Lehtimäki, MD, Principal investigator, Tampere University Hospital, Allergy centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025425
- Sponsor's protocol ID
- R16148_TAYS
- Status last verified
- Oct 2021
- First submitted
- 17 Jan 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Leivo-Korpela S, Rantala HA, Piili RP, Lehtimaki L, Lehto JT. Palliation of Dyspnea With Mouthpiece Ventilation in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Feasibility Study. J Palliat Med. 2023 Sep;26(9):1261-1265. doi: 10.1089/jpm.2023.0039. Epub 2023 May 4.
PubMed 37155710
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT03025425
- Acronym / sponsor ID
- R16148_TAYS
- Conditions
- COPD Exacerbation, Dyspnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in finding suitable patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 19 Jan 2017 (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.
An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure. Subjects are recruited from the local respiratory ward. The main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPV-arm | Experimental | Device: Trilogy 100 ® (Philips Respironics)Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a previous diagnosis of COPD
- hospitalized due to acute exacerbation of COPD
- at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)
- no acute hypoventilation (pH ≥ 7.35 and PCO2 ≤ 6.0 kPa)
- able to understand the study and to give informed consent
Key exclusion criteria (6 listed)
- unable to participate and use MPV due to e.g. delirium or lack of co-operation
- acute hypoventilation (pH < 7.35 or PCO2 > 6.0 kPa)
- acute need for ventilatory support
- the cause of the dyspnea can be successfully treated
- unable to give informed consent
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 |
|---|---|---|
| Trilogy 100 ® (Philips Respironics)Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics). | Device | MPV-arm |
Primary outcome
Change in dyspnea after initial period of using MPV
Time frame: 5-60 min
Change in dyspnea after initial period of using MPV
4 secondary outcomes
Change in dyspnea after 24 hours of using MPV
Time frame: 24 hours
Proportion of subjects having side-effects or not being compliant with MPV
Time frame: 24 hours
Proportion of subjects gaining from MPV
Time frame: 24 hours
Proportion of subjects willing to continue on MPV after the intervention
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Difficulty in finding suitable patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Derived from this study: PubMed 37155710Leivo-Korpela S, Rantala HA, Piili RP, Lehtimaki L, Lehto JT. Palliation of Dyspnea With Mouthpiece Ventilation in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Feasibility Study. J Palliat Med. 2023 Sep;26(9):1261-1265. doi: 10.1089/jpm.2023.0039. Epub 2023 May 4.
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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.
Lauri Lehtimäki, MD principal investigator
Tampere University Hospital, Allergy centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trilogy 100 ® (Philips Respironics) in people with COPD Exacerbation and Dyspnea, run by Tampere University Hospital at 1 site in Finland.
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 6 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 26 Oct 2021. 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 Finland. 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: Difficulty in finding suitable patients). 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?
Change in dyspnea after initial period of using MPV (time frame: 5-60 min). 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 NCT03025425, 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 26 Oct 2021.