COPDPhase 2/3COPDNCT03324607

Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI

A Phase 2/3 study testing hyperpolarized 129Xe gas MRI and Bevespi Aerosphere in people with COPD, run by Bastiaan Driehuys at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: hyperpolarized 129Xe gas MRI and Bevespi Aerosphere
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 20 Apr 2018to 12 Nov 2019
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating (forced expiratory volume at 1 second(FEV1)/forced vital capacity (FVC) < 0.70 and forced expiratory volume at 1 second (FEV1) in GOLD 2 or 3 stage (30%≤ (forced expiratory volume at 1 second [FEV1] < 80%)
Willing and able to give informed consent and adhere to visit/protocol schedules
Women of childbearing potential must have a negative urine pregnancy test

Who cannot join

Upper respiratory tract infection within 6 weeks
Chronic systemic corticosteroid use > 10 mg/day of prednisone
Chronic oxygen use (intermittent or continuous)
Previous lung resection surgery or decortication
Previous history of pneumothorax
Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies

Show all 17Show fewer

History of exposure to occupational or environmental hazards that are known to cause lung diseases
For women of child bearing potential, positive pregnancy test
Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
Patients who are not willing to withhold COPD inhalers for the run-in period.
MRI is contraindicated based on responses to MRI screening questionnaire
Subject is pregnant or lactating
Respiratory illness of a bacterial or viral etiology within 30 days of MRI
Subject has any form of known cardiac arrhythmia
Subject does not fit into 129Xe vest coil used for MRI
Subject cannot hold his/her breath for 15 seconds
Subject deemed unlikely to be able to comply with instructions during imaging

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI

Read the detailed description

The study will characterize ventilation and gas transfer distributions in GOLD II and III COPD patients and assess the potential for these physiological parameters as a novel phenotyping method using Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas.

The study will additionally quantify regional ventilation and gas transfer response to glycopyrrolate/formoterol in GOLD II and III COPD patients.

Conditions: COPD
Being tested: hyperpolarized 129Xe gas MRI, Bevespi Aerosphere
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.

hyperpolarized 129Xe gas MRIDrug
Also called 129Xe MRI
There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.
Bevespi AerosphereDrug
Also called Inhaler
There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.

Study groups in NCT03324607
Study group	Role	What they receive
single arm	Experimental	glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study XeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design. Receives: Drug: hyperpolarized 129Xe gas MRI; Drug: Bevespi Aerosphere

What is being measured

The primary outcome is the main question the study is designed to answer.

Ventilation Distribution as Measured by Ventilation Defect+Low Percent
The ventilation distribution as measured by ventilation defect+low percent is to measure the area of the lung that has no air.
Measured: Week 2
Barrier Uptake.
Diffusion of Xe gas across the lung membrane into the blood. This measures how well oxygen goes through the lung into the blood.
Measured: 2 weeks
Red Blood Cell (RBC) Uptake
Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane
Measured: 2 weeks

Secondary outcomes (9)

Pulmonary Function Test - Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry.
Measured: 2 weeks
Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1)
FEV1 is a lung airflow measure to assess the amount of air that can be blown out in one second.
Measured: 2 weeks
Pulmonary Function Test - Total Lung Capacity (TLC)
Total Lung Capacity (TLC) is the volume in the lungs at a maximal inhalation.
Measured: 2 weeks
Pulmonary Function Test - Residual Volume (RV)
Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation.
Measured: 2 weeks
Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
DLCO measures the ability of oxygen to travel from the air sacs of the lungs to the blood stream.
Measured: 2 weeks
6-minute Walk Test (6MWT)
The 6-minute walk test (6MWT) measures the distance walked at a natural pace for 6 minutes.
Measured: 2 weeks
St. George's Respiratory Questionnaire (SGRQ) Score
The SGRQ is used to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 2 weeks
Rating of Perceived Dyspnea (RPD) Scale
A patient reported outcome to measure perceived exertion during physical activity. The RPD scale goes from 0 to 10, where 0 = no shortness of breath at all and 10 = maximal shortness of breath (needing to stop the exercise or activity).
Measured: 2 weeks
COPD Assessment Test (CAT) Score
Functional measurement for COPD patients. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201812 Nov 2019

First posted27 Oct 2017
Study start20 Apr 2018
Primary completion12 Nov 2019
Study completion12 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
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 2/3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03324607
Sponsor's protocol ID: Pro00086693
Acronym: COPD
Status last verified: Dec 2020
First submitted: 29 Sep 2017
Last updated: 19 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
ClinicalTrials.gov ID: NCT03324607
Acronym / sponsor ID: COPD / Pro00086693
Conditions: COPD
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Bastiaan DriehuysUniversity, hospital or other
Study start: 20 Apr 2018 (actual)
Primary completion: 12 Nov 2019 (actual)
Study completion: 12 Nov 2019 (actual)
First posted: 27 Oct 2017 (actual)
Results: Posted 19 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will additionally quantify regional ventilation and gas transfer response to glycopyrrolate/formoterol in GOLD II and III COPD patients.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
single arm	Experimental	Drug: hyperpolarized 129Xe gas MRI, Drug: Bevespi Aerosphereglycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study XeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating (forced expiratory volume at 1 second(FEV1)/forced vital capacity (FVC) < 0.70 and forced expiratory volume at 1 second (FEV1) in GOLD 2 or 3 stage (30%≤ (forced expiratory volume at 1 second [FEV1] < 80%)
Willing and able to give informed consent and adhere to visit/protocol schedules
Women of childbearing potential must have a negative urine pregnancy test

Key exclusion criteria (17 listed)

Upper respiratory tract infection within 6 weeks
Chronic systemic corticosteroid use > 10 mg/day of prednisone

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
hyperpolarized 129Xe gas MRIAlso: 129Xe MRIThere will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.	Drug	single arm
Bevespi AerosphereAlso: InhalerThere will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.	Drug	single arm

Primary outcome

Ventilation Distribution as Measured by Ventilation Defect+Low Percent
Time frame: Week 2
The ventilation distribution as measured by ventilation defect+low percent is to measure the area of the lung that has no air.
Barrier Uptake.
Time frame: 2 weeks
Diffusion of Xe gas across the lung membrane into the blood. This measures how well oxygen goes through the lung into the blood.
Red Blood Cell (RBC) Uptake
Time frame: 2 weeks
Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane

9 secondary outcomes

Pulmonary Function Test - Forced Vital Capacity (FVC)
Time frame: 2 weeks
Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1)
Time frame: 2 weeks
Pulmonary Function Test - Total Lung Capacity (TLC)
Time frame: 2 weeks
Pulmonary Function Test - Residual Volume (RV)
Time frame: 2 weeks
Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Time frame: 2 weeks
6-minute Walk Test (6MWT)
Time frame: 2 weeks
St. George's Respiratory Questionnaire (SGRQ) Score
Time frame: 2 weeks
Rating of Perceived Dyspnea (RPD) Scale
Time frame: 2 weeks
COPD Assessment Test (CAT) Score
Time frame: 2 weeks

Results and safety

Results posted to the registry on 19 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	20	20

Primary outcome: Ventilation Distribution as Measured by Ventilation Defect+Low Percent

Time frame: Week 2. Mean (Standard Deviation). Unit: percentage of total ventilation

Measure	Treatment n = 17
Baseline	57.8 (8.4)
Week 2	52.5 (10.6)

Treatment: p = 0.006, Paired t-test

Population analysed: 17 participants were included in the data analysis. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit.

Primary outcome: Barrier Uptake.

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Single Arm n = 17
increase in barrier uptake	13
No increase in barrier uptake	4

Population analysed: 17 patients with GOLD 2 or 3 COPD 17 participants were included in the data analysis. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit.

Primary outcome: Red Blood Cell (RBC) Uptake

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Single Arm n = 17
Decrease in red blood cell (RBC) uptake	10
No decrease in red blood cell (RBC) uptake	7

Population analysed: GOLD 2 and 3 COPD 17 participants were included in the data analysis. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): 20 subjects completed the study. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit; thus, a total of 17 subjects (8M 9F) were included in the data analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for COPD

Active, not recruiting
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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.

Yuh Chin Huang, MD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing hyperpolarized 129Xe gas MRI and Bevespi Aerosphere in people with COPD, run by Bastiaan Driehuys at 1 site in United States.

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 3 inclusion and 17 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: finished, as of the sponsor's last update on 19 Jan 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 United States. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ventilation Distribution as Measured by Ventilation Defect+Low Percent (time frame: Week 2). 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 NCT03324607.

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 19 Jan 2021.