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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 45 minutes post inhalation
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have smoked more than 10 packs of cigarettes a year in the past.
Select...
My doctor has diagnosed me with COPD.
Select...
I have been using LAMA/LABA medication regularly for over a month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 45 minutes post inhalation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 45 minutes post inhalation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Albuterol
Secondary outcome measures
Albuterol induced absolute change in PVR
Oxygen Saturation
Percent change in FEV1
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
900 Previous Clinical Trials
409,902 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,605,252 Total Patients Enrolled
Adam Wanner, MDPrincipal InvestigatorUniversity of Miami
9 Previous Clinical Trials
353 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I regularly use medication to widen my lung blood vessels.I haven't taken steroid medications in the last 6 weeks.Your blood pressure is too high on the test day.You had high blood pressure in the right side of your heart during a previous heart ultrasound.Your oxygen level is less than 90% when breathing normally.I had COVID-19 within the last 4 weeks.You are allergic to inhaled corticosteroids.I received a COVID vaccine less than 3 months ago.I have smoked more than 10 packs of cigarettes a year in the past.You regularly need to use oxygen at home when you are not doing any physical activity.I am currently taking beta-blocker medication.I need oxygen therapy all the time.I am a woman who can have children and do not use birth control.My doctor diagnosed me with obesity hypoventilation syndrome.You are currently smoking or using vaping products with tobacco or other substances.I have used inhaled corticosteroids within the last 4 weeks.You are allergic to albuterol.I have had a severe COPD flare-up needing urgent care or steroids within the last 6 weeks.I am between 40 and 80 years old.My doctor has diagnosed me with COPD.Your lung function test results show that your breathing capacity is between 50-80% of what is expected, and your FEV1 and FVC ratio is less than 0.7.I have not had a respiratory infection in the last 4 weeks.I have been using LAMA/LABA medication regularly for over a month.
Research Study Groups:
This trial has the following groups:- Group 1: Bretzri followed by Bevespi Group
- Group 2: Bevespi followed by Bretzri Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently openings available to participants in this experiment?
"Clinicaltrials.gov data shows that this medical research is not currently seeking participants, having been initially posted on October 1st 2023 and last edited November 2nd 2022. Despite the lack of recruitment for this clinical trial, there are still 475 other studies actively accepting patients at present time."
Answered by AI
Is it possible for me to register in this trial?
"This COPD treatment trial is seeking 30 people between 40 and 80 years of age. Candidates must have a prior medical diagnosis, 10+ pack-years of smoking history, FEV1/FVC ratio less than 0.7, baseline post-bronchodilator one second forced expiratory volume (FEV1) 50 to 80% predicted, and be taking long acting muscarinic agonists / long-acting beta2 adrenergic receptor agonist drugs for at least 4 weeks before participating in the study."
Answered by AI
What safety measures have been taken to ensure the efficacy of combining Bretzri with Bevespi Group for patient treatment?
"Our team at Power has assigned a score of 2 to the drug combination of Bretzri followed by Bevespi Group, as there is evidence supporting its safety but not yet any data verifying efficacy."
Answered by AI
Is this medical trial accepting elderly participants over the age of seventy-five?
"As laid out in the inclusion criteria for this trial, only patients aged 40 to 80 are eligible. There are 34 studies available for those under 18 years and 459 studies accessible by those older than 65."
Answered by AI
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