Chronic Obstructive Pulmonary DiseasePhase 2NCT05607719
Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD
A Phase 2 study testing Bevespi and Bretzri in people with Chronic Obstructive Pulmonary Disease, run by University of Miami at 1 site in United States.
Trial summary
The study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bevespi and Bretzri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 31 Jul 2026
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physician diagnosis of COPD
- former smoking history of more than 10 pack-years
- baseline post-bronchodilator one-second forced expiratory volume (FEV1) 50-80% of predicted, baseline FEV1 and forced vital capacity (FVC) ratio <0.7
- males and females, 40-80 years of age
- regular use of a LAMA/LABA drug regimen for at least a month
Who cannot join
- women of childbearing potential who do not use accepted birth- control measures
- pregnant and breast-feeding women
- respiratory infection within 4 weeks of a test day
- a Corona Virus Disease (COVID) vaccination <3 months prior to study entry
- ICS use (within 4 weeks of study entry)
- ICS hypersensitivity
Show all 19Show fewer
- albuterol intolerance
- use of beta-blocker medication (oral and ophthalmic)
- use of systemic glucocorticosteroid medication within 6 wk prior to the screening visit
- an acute COPD exacerbation within 6 wk of the screening day (defined as a need for antibiotic or systemic glucocorticoid therapy or emergency department (ED) visit/hospitalization)
- current smoking or vaping tobacco or other products
- Oxygen (O2) saturation of <90% at-rest breathing room air
- Long-term oxygen therapy (LTOT) required at rest
- regular use of pulmonary vasodilators
- systemic arterial systolic pressure >150 mmHg and diastolic pressure >100 mmHg on the test day
- a >40mmHg right ventricular systolic pressure (RVSP) by prior echocardiography
- a documented COVID infection within 4 weeks of the screening day
- Regular use of home oxygen at rest
- Physician diagnosis of obesity hypoventilation syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Inhaled Corticosteroids (ICS) Adjunct Therapy on Pulmonary Vascular Endothelial Function in Chronic Obstructive Pulmonary Disease (COPD): Comparison of Two Standard Treatments (NCT05607719
The study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Bevespi, Bretzri
- 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.
BevespiDrug
Two puffs twice a day
BretzriDrug
Two puffs twice a day
| Study group | Role | What they receive |
|---|---|---|
| Bretzri followed by Bevespi Group | Experimental | Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi. Receives: Drug: Bevespi; Drug: Bretzri |
| Bevespi followed by Bretzri Group | Experimental | Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri. Receives: Drug: Bevespi; Drug: Bretzri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albuterol induced percent change in pulmonary vascular resistance (PVR)
Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function
Measured: baseline to 15 minutes post inhalation
Secondary outcomes (3)
Albuterol induced absolute change in PVR
Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function
Measured: baseline, up to 45 minutes post inhalation
Percent change in FEV1
Percent change in FEV1 will be measured using spirometry
Measured: baseline to 15 minutes post inhalation
Change in oxygen saturation
Change in oxygen saturation measured by pulse oximetry
Measured: baseline, up to 45 minutes post inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start11 Apr 2023
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
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 University of MiamiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Adam Wanner, University of Miami
- Investigators
- Adam Wanner, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607719
- Sponsor's protocol ID
- 20220347
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inhaled Corticosteroids (ICS) Adjunct Therapy on Pulmonary Vascular Endothelial Function in Chronic Obstructive Pulmonary Disease (COPD): Comparison of Two Standard Treatments (NCT05607719
- ClinicalTrials.gov ID
- NCT05607719
- Acronym / sponsor ID
- 20220347
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 7 Nov 2022 (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.
The study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bretzri followed by Bevespi Group | Experimental | Drug: Bevespi, Drug: BretzriParticipants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi. |
| Bevespi followed by Bretzri Group | Experimental | Drug: Bevespi, Drug: BretzriParticipants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- physician diagnosis of COPD
- former smoking history of more than 10 pack-years
- baseline post-bronchodilator one-second forced expiratory volume (FEV1) 50-80% of predicted, baseline FEV1 and forced vital capacity (FVC) ratio <0.7
- males and females, 40-80 years of age
- regular use of a LAMA/LABA drug regimen for at least a month
Key exclusion criteria (19 listed)
- women of childbearing potential who do not use accepted birth- control measures
- pregnant and breast-feeding women
- respiratory infection within 4 weeks of a test day
- a Corona Virus Disease (COVID) vaccination <3 months prior to study entry
- ICS use (within 4 weeks of study entry)
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 |
|---|---|---|
| BevespiTwo puffs twice a day | Drug | Bevespi followed by Bretzri Group, Bretzri followed by Bevespi Group |
| BretzriTwo puffs twice a day | Drug | Bevespi followed by Bretzri Group, Bretzri followed by Bevespi Group |
Primary outcome
Albuterol induced percent change in pulmonary vascular resistance (PVR)
Time frame: baseline to 15 minutes post inhalation
Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function
3 secondary outcomes
Albuterol induced absolute change in PVR
Time frame: baseline, up to 45 minutes post inhalation
Percent change in FEV1
Time frame: baseline to 15 minutes post inhalation
Change in oxygen saturation
Time frame: baseline, up to 45 minutes post inhalation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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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.
Adam Wanner, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevespi and Bretzri in people with Chronic Obstructive Pulmonary Disease, run by University of Miami 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 5 inclusion and 19 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 8 Sep 2026. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Albuterol induced percent change in pulmonary vascular resistance (PVR) (time frame: baseline to 15 minutes post inhalation). 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 Sep 2026.