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

NCT ID: NCT01783821

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-12-31

Brief 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.

Detailed Description

Subjects were randomized to either placebo or combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 calendar days for a total of 10 doses or until hospital discharge or death. Local hospital pharmacies prepared identical appearing solutions and drug was delivered by respiratory therapists blinded to randomization by using standard jet nebulizers that produce aerosol particle size within the respirable range (<5.5 microns). The first dose was administered within 4 hours after randomization.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Budesonide and Formoterol

Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.

Group Type: EXPERIMENTAL

Budesonide

Intervention Type: DRUG

Subjects will receive the standard aerosolized dose of budesonide (0.5 mg).

Formoterol

Intervention Type: DRUG

Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .

Placebo

Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same.

Interventions

Budesonide

Subjects will receive the standard aerosolized dose of budesonide (0.5 mg).

Intervention Type: DRUG

Placebo

Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same.

Intervention Type: DRUG

Formoterol

Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .

Intervention Type: DRUG

Other Intervention Names

Pulmicort; Foradil Aerolizer

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Emir Festic

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emir Festic, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

University of Arizona

Tucson, Arizona, United States

Stanford University

Stanford, California, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Beth Israel Medical Center

Boston, Massachusetts, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

Festic E, Carr GE, Cartin-Ceba R, Hinds RF, Banner-Goodspeed V, Bansal V, Asuni AT, Talmor D, Rajagopalan G, Frank RD, Gajic O, Matthay MA, Levitt JE. Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome. Crit Care Med. 2017 May;45(5):798-805. doi: 10.1097/CCM.0000000000002284.

Reference Type: DERIVED

PMID: 28240689 (View on PubMed)

Other Identifiers

UL1RR024150

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-008192

Identifier Type: -

Identifier Source: org_study_id