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Inhaled Corticosteroid/Long-Acting Beta Agonist/Long-Acting Muscarinic Antagonist Combination
Outcomes of Once-Daily ICS/LABA/LAMA Plus PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations (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
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of PRN respiratory therapy drugs per day (PRN treatments with short acting bronchodilators via nebulization given by respiratory therapists).
Secondary study objectives
Hospital Length of stay
Number of readmissions
Awards & Highlights
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.
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
206 Previous Clinical Trials
203,345 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.