Chronic Obstructive Pulmonary DiseaseNCT03657082
Effects of PEP on IC During IT in Patients With COPD
A study testing PEP-10 and PEP-1 in people with Chronic Obstructive Pulmonary Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will investigate the effects of positive expiratory pressure (PEP) on hyperinflation in patients with chronic obstructive pulmonary disease (COPD). Inspiratory capacity (IC) is the primary outcome Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PEP-10 and PEP-1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2018to 30 Dec 2021
- 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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable COPD since 1 month at least
- Able to understand the instructions
Who cannot join
- COPD with a forced expiratory volume at one second > 80% of predicted values
- In exacerbation
- Orthopedic of neurological condition likely to interfere with the experimentation
- Contraindication to perform exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Positive Expiratory Pressure on Inspiratory Capacity and Dyspnea in Patients With COPD During Exercise
This study will investigate the effects of positive expiratory pressure (PEP) on hyperinflation in patients with chronic obstructive pulmonary disease (COPD). Inspiratory capacity (IC) is the primary outcome
Read the detailed description
This is a cross-over intervention assessing the effect of PEP on IC and dyspnea in patients with COPD performing an interval training (IT) session.
IC will be measured before, during and immediately after the IT session. Each participant will receive perform IT sessions including either the use of a PEP of 10 cmH2O or a PEP of 1 cmH2O. The effects on IC and dyspnea on both PEP levels will be assessed.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- PEP-10, PEP-1
- 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.
PEP-10Device
Bottle PEP with a water level of 10 cmH2O
PEP-1Device
Bottle PEP with a water level of 1 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | In this arm, patients will receive the experimental condition first, then the sham condition Receives: Device: PEP-10; Device: PEP-1 |
| Arm B | Experimental | In this arm, patients will receive the sham condition first, then the experimental condition Receives: Device: PEP-10; Device: PEP-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inspiratory capacity
Evolution of inspiratory capacity while performing the interval training session
Measured: 20 minutes
Secondary outcomes (1)
Change in Borg scale
Evolution of dyspnea while performing the interval training session
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start15 Sep 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Why it stopped: No financial support found
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657082
- Sponsor's protocol ID
- PEP-IC
- Status last verified
- May 2024
- First submitted
- 28 Aug 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive Expiratory Pressure on Inspiratory Capacity and Dyspnea in Patients With COPD During Exercise
- ClinicalTrials.gov ID
- NCT03657082
- Acronym / sponsor ID
- PEP-IC
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No financial support found
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 4 Sep 2018 (actual)
- 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.
This study will investigate the effects of positive expiratory pressure (PEP) on hyperinflation in patients with chronic obstructive pulmonary disease (COPD). Inspiratory capacity (IC) is the primary outcome
Detailed description
This is a cross-over intervention assessing the effect of PEP on IC and dyspnea in patients with COPD performing an interval training (IT) session.
IC will be measured before, during and immediately after the IT session. Each participant will receive perform IT sessions including either the use of a PEP of 10 cmH2O or a PEP of 1 cmH2O. The effects on IC and dyspnea on both PEP levels will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Device: PEP-10, Device: PEP-1In this arm, patients will receive the experimental condition first, then the sham condition |
| Arm B | Experimental | Device: PEP-10, Device: PEP-1In this arm, patients will receive the sham condition first, then the experimental condition |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable COPD since 1 month at least
- Able to understand the instructions
Key exclusion criteria (4 listed)
- COPD with a forced expiratory volume at one second > 80% of predicted values
- In exacerbation
- Orthopedic of neurological condition likely to interfere with the experimentation
- Contraindication to perform exercise
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 |
|---|---|---|
| PEP-10Bottle PEP with a water level of 10 cmH2O | Device | Arm A, Arm B |
| PEP-1Bottle PEP with a water level of 1 cmH2O | Device | Arm A, Arm B |
Primary outcome
Change in inspiratory capacity
Time frame: 20 minutes
Evolution of inspiratory capacity while performing the interval training session
1 secondary outcome
Change in Borg scale
Time frame: 20 minutes
Results and safety
The study was stopped early (reason given: No financial support found). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP-10 and PEP-1 in people with Chronic Obstructive Pulmonary Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 4 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 8 May 2024. 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 Belgium. 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: No financial support found). 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 inspiratory capacity (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.