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ICS for COPD

Phase 2
Recruiting
Led By Adam Wanner, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Former smoking history of more than 10 pack-years
Physician diagnosis of COPD
Must not have
Use of systemic glucocorticosteroid medication within 6 wk prior to the screening visit
Regular use of pulmonary vasodilators
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 45 minutes post inhalation
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if adding an ICS to a COPD treatment can improve breathing by testing how well blood vessels dilate in response to albuterol.

Who is the study for?
This trial is for former smokers aged 40-80 with a physician's diagnosis of COPD, who have been on a LAMA/LABA regimen for at least one month. They should not be current smokers or have used ICS recently. Participants must not have had certain vaccinations, acute COPD exacerbations, respiratory infections recently, or specific cardiovascular issues.
What is being tested?
The study tests if adding an inhaled corticosteroid (ICS) to existing treatment with LABA and LAMA improves lung blood vessel function in stable COPD patients. This response is measured after inhaling albuterol over four weeks.
What are the potential side effects?
Potential side effects from the ICS may include sore throat, hoarseness, thrush (a fungal infection in the mouth), coughing, headaches and vision changes. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have smoked more than 10 packs of cigarettes a year in the past.
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My doctor has diagnosed me with COPD.
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I have been using LAMA/LABA medication regularly for over a month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken steroid medications in the last 6 weeks.
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I regularly use medication to widen my lung blood vessels.
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I had COVID-19 within the last 4 weeks.
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I am currently taking beta-blocker medication.
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I need oxygen therapy all the time.
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I am a woman who can have children and do not use birth control.
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My doctor diagnosed me with obesity hypoventilation syndrome.
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I have used inhaled corticosteroids within the last 4 weeks.
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I have had a severe COPD flare-up needing urgent care or steroids within the last 6 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 45 minutes post inhalation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 45 minutes post inhalation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Albuterol
Secondary study objectives
Albuterol induced absolute change in PVR
Oxygen Saturation
Percent change in FEV1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Bretzri followed by Bevespi GroupExperimental Treatment2 Interventions
Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi.
Group II: Bevespi followed by Bretzri GroupExperimental Treatment2 Interventions
Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
949 Previous Clinical Trials
428,434 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,627 Total Patients Enrolled
Adam Wanner, MDPrincipal InvestigatorUniversity of Miami
9 Previous Clinical Trials
353 Total Patients Enrolled

Media Library

Bretzri followed by Bevespi Group Clinical Trial Eligibility Overview. Trial Name: NCT05607719 — Phase 2
Chronic Obstructive Pulmonary Disease Research Study Groups: Bretzri followed by Bevespi Group, Bevespi followed by Bretzri Group
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Bretzri followed by Bevespi Group Highlights & Side Effects. Trial Name: NCT05607719 — Phase 2
Bretzri followed by Bevespi Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607719 — Phase 2
~3 spots leftby Jan 2025
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