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Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevespi
Bretzri
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bretzri followed by Bevespi Group

Bevespi followed by Bretzri Group

Arm Description

Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi.

Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Albuterol induced absolute change in PVR
Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function
Percent change in FEV1
Percent change in FEV1 will be measured using spirometry
Change in oxygen saturation
Change in oxygen saturation measured by pulse oximetry

Full Information

First Posted
November 2, 2022
Last Updated
April 12, 2023
Sponsor
University of Miami
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT05607719
Brief Title
Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bretzri followed by Bevespi Group
Arm Type
Experimental
Arm Description
Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi.
Arm Title
Bevespi followed by Bretzri Group
Arm Type
Experimental
Arm Description
Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.
Intervention Type
Drug
Intervention Name(s)
Bevespi
Intervention Description
Two puffs twice a day
Intervention Type
Drug
Intervention Name(s)
Bretzri
Intervention Description
Two puffs twice a day
Primary Outcome Measure Information:
Title
Albuterol induced percent change in pulmonary vascular resistance (PVR)
Description
Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function
Time Frame
baseline to 15 minutes post inhalation
Secondary Outcome Measure Information:
Title
Albuterol induced absolute change in PVR
Description
Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function
Time Frame
baseline, up to 45 minutes post inhalation
Title
Percent change in FEV1
Description
Percent change in FEV1 will be measured using spirometry
Time Frame
baseline to 15 minutes post inhalation
Title
Change in oxygen saturation
Description
Change in oxygen saturation measured by pulse oximetry
Time Frame
baseline, up to 45 minutes post inhalation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Wanner, MD
Phone
(305) 243-2568
Email
awanner@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Biondo
Phone
(305) 243-2568
Email
jnb184@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Wanner, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Biondo
Phone
305-243-2568
Email
jnb184@miami.edu
First Name & Middle Initial & Last Name & Degree
Adam Wanner, MD
First Name & Middle Initial & Last Name & Degree
Barry Hurtwitz, PhD

12. IPD Sharing Statement

Learn more about this trial

Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

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