Steroid Resistance During COPD Exacerbations With Respiratory Failure (NCT03680495) | Clinical Trial Compass
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Steroid Resistance During COPD Exacerbations With Respiratory Failure
United States46 participantsStarted 2017-07-21
Plain-language summary
Chronic obstructive pulmonary disease (COPD) is a lung disease caused by cigarette smoke that affects millions of people. In the United States, COPD is the 3rd leading cause of death making it one of our most important public health problems. Some people with COPD get disease flares that are called acute exacerbations of COPD - or AECOPDs for short. When people get an AECOPD they experience increased shortness of breath, wheezing and cough; symptoms that often require urgent or emergent treatment by healthcare providers. In the most severe, life-threatening situations, people with AECOPDs are put on a ventilator in the emergency department and admitted to the intensive care unit. Most AECOPDs can be treated with low doses of medications called steroids. This is good because high doses of steroids can cause unwanted side effects. Unfortunately, recent studies suggest that the sickest people, those admitted to the intensive care unit needing ventilator support, need higher doses of steroids because they may have resistance to these important medications. The investigators are studying steroid resistance during very severe AECOPDs so that we can eventually develop better and safer therapies for these vulnerable people.
Who can participate
Age range
40 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for AECOPD with Ventilatory Failure Cohort:
* Emergency Department (ED) or ICU physician diagnosis of an acute exacerbation of COPD
* Age ≥ 40 years of age
* Need for ventilator support in the ED or ICU during the first 24 hours
Inclusion Criteria for Stable COPD Cohort:
* Physician diagnosis of COPD
* Age ≥ 40 years of age
* Frequency matched to AECOPD subjects for:
* Age (± 10 year increments)
* Current/Former smoking status (former smoker = no smoking for ≥ 1 month)
* Lung function (FEV1% predicted by ± 10% increments)
Exclusion Criteria for AECOPD with Ventilatory Failure Cohort:
* Systemic steroid use ≤ 30 days prior to return visit
* Infection requiring antibiotics ≤ 1 month prior to return visit
* Hemoglobin \< 8.0 g/dl
* Acute pulmonary embolism
* Diabetes
* History of immunodeficiency, interstitial lung disease, neuromuscular disorder or heart failure with respiratory exacerbation
* Tracheostomy
* Drugs that induce cytochrome P450 3A enzyme activity (e.g. barbiturates, phenytoin or carbamazepine) or drugs that inhibit cytochrome P450 3A activity (e.g. ketoconazole and chronic macrolide antibiotics)
* Age ≥ 90 year of age
* Known pregnancy
* Nursing mothers
* Prisoners
Exclusion Criteria for Stable COPD Cohort:
* Systemic steroid use ≤ 30 days prior to return visit
* Infection requiring antibiotics ≤ 1 month prior to return visit
* Hemoglobin \< 8.0 g/dl
* Acute pulmonary embolism
* Diabetes
* History of immunodeficiency, interstitial …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of steroid resistance in patients recently admitted with an acute exacerbation of chronic obstructive pulmonary disease with respiratory failure.
Timeframe: Once at ≥ 45 days after hospital discharge