CompletedPhase 2

LIPS-B: Lung Injury Prevention Study With Budesonide and Beta

United States61 participantsStarted 2013-07

Plain-language summary

This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD), but the use of these two drugs is experimental for ARDS.

Who can participate

Age range

18 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: * Adult patients (age \> 18) * Admitted to the hospital through the emergency department (ED) * High risk of developing ARDS (Lung Injury Prediction Score (LIPS) greater than or equal to four) Exclusion Criteria: * Inhaled corticosteroid and/or beta agonist treatment on admission or within 7 days prior to admission (history of asthma or COPD necessitating therapy) * Chronic pulmonary disease requiring daytime oxygen supplementation therapy * Systemic steroid treatment on admission or within 7 days prior to admission equivalent to more than 5 mg of prednisone daily * Inability to obtain consent within 12 hours of hospital presentation * Acute lung injury prior to randomization * Receiving mechanical ventilation before current hospital admission (patient who is ventilator dependent) * Presentation believed to be purely due to heart failure without other known risk factors for ARDS * Allergy or other contraindication to either budesonide and/or formoterol use * Expected hospital stay and/or survival \<48 hours or admission for comfort or hospice care * Patient, surrogate or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest) * Previous enrollment in this trial. * Co-enrollment with LIPS-A trial is not allowed. * An active enrollment in other concomitant trial will be judged on case by case basis by PIs of both trials. * EKG a…

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

Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio

Timeframe: baseline to day 5 after the first treatment

Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio

Timeframe: Days 0 - 5

Trial details

NCT IDNCT01783821

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2016-06-08

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome (ARDS) trials