CopdPhase 4NCT02989935
RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD
A Phase 4 study testing Ventilation, Parasternal EMG and Phrenic magnetic stimulation in people with Copd, run by University of Calgary at 1 site in Canada.
Trial summary
This study examines the effect of the ultra long acting beta agonist/corticosteroid bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles and ventilation in adults with severe bronchitis or emphysema (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd
- What is being tested?
- Ventilation, Parasternal EMG and Phrenic magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- ambulatory, stable severe COPD (GOLD Class III-IV)
- on long acting bronchodilator therapy
- compliant with use of prescribed medications
- fit for minor surgical procedure including intravenous sedation
Who cannot join
- hypersensitivity to milk proteins
- hypersensitive to fluticasone furoate/vilanterol formulation
- angina or substantial cardiovascular risk
- exacerbation of COPD within the preceding 2 months
- significant non-respiratory system disease
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the effect of the ultra long acting beta agonist/corticosteroid bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles and ventilation in adults with severe bronchitis or emphysema (COPD).
Read the detailed description
In adults with severe, minimally reversible bronchitis or emphysema (COPD), there is progressive hyperinflation of the lungs with associated flattening and inefficiency of the major respiratory muscle, the diaphragm. These changes limit physical activity and exercise, and provoke shortness of breath - dyspnea.
These debilitating symptoms are often significantly lessened with ultra long acting combination bronchodilators, even in adults where the bronchodilator does not produce any measurable improvement in either airflow or lung hyperinflation.
This symptomatic improvement in adults with severe, minimally reversible COPD may occur because of a direct benefit of the bronchodilator on respiratory muscles and ventilation.
This study examines the effect of the ultra long acting bronchodilator fluticasone furoate/vilanterol trifenatate upon the upper anterior chest wall respiratory muscles (parasternals), the diaphragm, and breathing pattern.
- Conditions
- Copd
- Being tested
- Ventilation, Parasternal EMG, Phrenic magnetic stimulation
- Keywords
- respiratory muscle, bronchodilator
- 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.
VentilationProcedure or surgery
Measurements of ventilation with subjects seated, and breathing across a pneumotachygraph and pressure transducer to measure inspiratory airflow, during both resting and CO2 stimulated breathing.
Parasternal EMGProcedure or surgery
Recordings of electrical activity (EMG) from the parasternal intercostal muscle in the second intercostal space on the upper anterior chest wall adjacent to the sternum.
Phrenic magnetic stimulationProcedure or surgery
Bilateral maximal magnetic stimulation (Magstim) of the phrenic nerves.
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone vilanterol bronchodilator | Experimental | Inhalation of fluticasone furoate/vilanterol trifenatate, 100 mcg/25 mcg combination, bronchodilator,using standard dry powder inhaler.
Interventions include ventilation, parasternal EMG, and phrenic magnetic stimulation. Receives: Procedure: Ventilation; Procedure: Parasternal EMG; Procedure: Phrenic magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute ventilation change
Minute ventilation will be averaged and compared, before and then 2 hours after the bronchodilator inhalation.
Measured: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Parasternal EMG change
Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.
Measured: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Pressure change with phrenic stimulation
Change in recorded mouth pressure during magnetic stimulation of the phrenic nerves.
Measured: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startApr 2016
- Primary completion31 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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 CopdStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Easton, University of Calgary
- Investigators
- Paul A Easton, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989935
- Sponsor's protocol ID
- REB16-0147
- Status last verified
- Feb 2025
- First submitted
- 1 Dec 2016
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Participant physiologic results and measurements publicly presented.
Publications
Easton PA, Hawes HG, Doig CJ, Johnson MW, Yokoba M, Wilde ER. Parasternal muscle activity decreases in severe COPD with salmeterol-fluticasone propionate. Chest. 2010 Mar;137(3):558-65. doi: 10.1378/chest.09-0197. Epub 2009 Oct 9.
PubMed 19820074
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD
- ClinicalTrials.gov ID
- NCT02989935
- Acronym / sponsor ID
- REB16-0147
- Conditions
- Copd
- Keywords
- respiratory muscle, bronchodilator
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Dec 2016 (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.
This study examines the effect of the ultra long acting beta agonist/corticosteroid bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles and ventilation in adults with severe bronchitis or emphysema (COPD).
Detailed description
In adults with severe, minimally reversible bronchitis or emphysema (COPD), there is progressive hyperinflation of the lungs with associated flattening and inefficiency of the major respiratory muscle, the diaphragm. These changes limit physical activity and exercise, and provoke shortness of breath - dyspnea.
These debilitating symptoms are often significantly lessened with ultra long acting combination bronchodilators, even in adults where the bronchodilator does not produce any measurable improvement in either airflow or lung hyperinflation.
This symptomatic improvement in adults with severe, minimally reversible COPD may occur because of a direct benefit of the bronchodilator on respiratory muscles and ventilation.
This study examines the effect of the ultra long acting bronchodilator fluticasone furoate/vilanterol trifenatate upon the upper anterior chest wall respiratory muscles (parasternals), the diaphragm, and breathing pattern.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study of RELVAR drug effect on respiratory physiology variables including breathing pattern, and EMG.
| Arm | Type | Receives |
|---|---|---|
| Fluticasone vilanterol bronchodilator | Experimental | Procedure: Ventilation, Procedure: Parasternal EMG, Procedure: Phrenic magnetic stimulationInhalation of fluticasone furoate/vilanterol trifenatate, 100 mcg/25 mcg combination, bronchodilator,using standard dry powder inhaler. Interventions include ventilation, parasternal EMG, and phrenic magnetic stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ambulatory, stable severe COPD (GOLD Class III-IV)
- on long acting bronchodilator therapy
- compliant with use of prescribed medications
- fit for minor surgical procedure including intravenous sedation
Key exclusion criteria (5 listed)
- hypersensitivity to milk proteins
- hypersensitive to fluticasone furoate/vilanterol formulation
- angina or substantial cardiovascular risk
- exacerbation of COPD within the preceding 2 months
- significant non-respiratory system disease
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 |
|---|---|---|
| VentilationMeasurements of ventilation with subjects seated, and breathing across a pneumotachygraph and pressure transducer to measure inspiratory airflow, during both resting and CO2 stimulated breathing. | Procedure or surgery | Fluticasone vilanterol bronchodilator |
| Parasternal EMGRecordings of electrical activity (EMG) from the parasternal intercostal muscle in the second intercostal space on the upper anterior chest wall adjacent to the sternum. | Procedure or surgery | Fluticasone vilanterol bronchodilator |
| Phrenic magnetic stimulationBilateral maximal magnetic stimulation (Magstim) of the phrenic nerves. | Procedure or surgery | Fluticasone vilanterol bronchodilator |
Primary outcome
Minute ventilation change
Time frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Minute ventilation will be averaged and compared, before and then 2 hours after the bronchodilator inhalation.
Parasternal EMG change
Time frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.
Pressure change with phrenic stimulation
Time frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.
Change in recorded mouth pressure during magnetic stimulation of the phrenic nerves.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 19820074Easton PA, Hawes HG, Doig CJ, Johnson MW, Yokoba M, Wilde ER. Parasternal muscle activity decreases in severe COPD with salmeterol-fluticasone propionate. Chest. 2010 Mar;137(3):558-65. doi: 10.1378/chest.09-0197. Epub 2009 Oct 9.
- Individual participant dataSharing planned: Yes. Participant physiologic results and measurements publicly presented.
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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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.
Paul A Easton, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ventilation, Parasternal EMG and Phrenic magnetic stimulation in people with Copd, run by University of Calgary at 1 site in Canada.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Minute ventilation change (time frame: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.). The study lists 3 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 NCT02989935, 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 18 Feb 2025.