Overview

This trial is active, not recruiting.

Condition acute respiratory distress syndrome (ards)
Treatments budesonide and formoterol, placebo
Phase phase 2
Sponsor Mayo Clinic
Collaborator Stanford University
Start date July 2013
End date July 2015
Trial size 60 participants
Trial identifier NCT01783821, 12-008192

Summary

THE STUDY WILL ANSWER WHETHER INHALED BUDESONIDE AND FORMOTEROL ARE ABLE TO ALLEVIATE OR PREVENT PULMONARY INJURY WHEN ADMINISTERED EARLY IN HOSPITAL COURSE TO THE PATIENTS AT RISK FOR DEVELOPING ARDS

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Budesonide and formoterol
budesonide and formoterol
Patients randomized to one of two intervention arms, will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) every 12 hours, for 5 days or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
(Placebo Comparator)
Normal saline, the quantity and appearance same as the intervention arm.
placebo

Primary Outcomes

Measure
Change in oxygen saturation to fraction of inspired oxygen concentration (S/F) ratio
time frame: Change in S/F ratio from baseline to day 5 after the first treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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 and/or clinical presentation suggestive of acute coronary ischemia - New onset cardiac arrhythmia - Current atrial fibrillation with ventricular rate of >110/minute - Persistent sinus tachycardia of >130/minute despite early goal directed therapy with fluids, pressors, antibiotics and supplemental oxygen Pregnant patients

Additional Information

Official title LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)
Principal investigator Emir Festic, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.