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Inhaled Corticosteroid/Long-Acting Beta Agonist/Long-Acting Muscarinic Antagonist Combination
TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation for Chronic Obstructive Pulmonary Disease (Sundial-COPD Trial)
Phase 4
Waitlist Available
Led By Mark W Millard, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights
Sundial-COPD Trial Summary
This trial is designed to evaluate if adding TRELEGY ELLIPTA to a short-term systemic corticosteroid therapy can help improve symptoms in hospitalized subjects with COPD with or without asthma, and if it is safe to use.
Sundial-COPD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of PRN respiratory therapy drugs per day (PRN treatments with short acting bronchodilators via nebulization given by respiratory therapists).
Secondary outcome measures
Hospital Length of stay
Number of readmissions
Sundial-COPD Trial Design
1Treatment groups
Experimental Treatment
Group I: COPD subjectsExperimental Treatment1 Intervention
COPD with or without asthma
Find a Location
Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,341 Total Patients Enrolled
Mark W Millard, MDPrincipal InvestigatorBaylor Scott and White Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to use the Ellipta device correctly.
Research Study Groups:
This trial has the following groups:- Group 1: COPD subjects
Awards:
This trial has 5 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 any open enrollment opportunities for this investigation?
"According to clinicaltrials.gov, the posted trial is not actively recruiting at this time; it was initially made available on April 1st 2022 and most recently updated on March 22nd of that same year. However, there are 16 additional medical studies currently seeking participants."
Answered by AI
To what extent could TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation potentially be harmful?
"We rate TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation a 3, as it has completed Phase 4 of clinical trials and is officially approved."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
How old are they?
65+
What site did they apply to?
Baylor Scott & White Health Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
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