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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Collaborators:
Stanford University
Beth Israel Deaconess Medical Center
University of Arizona
Information provided by (Responsible Party):
Emir Festic, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01783821
First received: January 31, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Acute Respiratory Distress Syndrome (ARDS)
Drug: Budesonide and formoterol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: budesonide and formoterol
Budesonide and formoterol
Drug: 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: Placebo
Normal saline, the quantity and appearance same as the intervention arm.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • New chest radiograph performed on clinical grounds

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783821

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85721
Contact: Gordon Carr, MD       gcarr@deptofmed.arizona.edu   
Contact: Heidi Erickson       herickso@email.arizona.edu   
Principal Investigator: Gordon Carr, MD         
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Rosemary Vojnik       rvojnik@stanford.edu   
Principal Investigator: Joseph E Levitt, MD         
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Pamela Long, BSN    904-953-7719    long.pamela@mayo.edu   
Contact: Kellie Ruday, BS    (904) 9537766    ruday.kellie@mayo.edu   
Principal Investigator: Emir Festic, M.D.         
United States, Massachusetts
Beth Israel Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Valerie Goodspeed       vgoodspe@bidmc.harvard.edu   
Principal Investigator: Daniel Talmor, MD         
United States, Minnesota
Mayo Clinic in Rochester Active, not recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Stanford University
Beth Israel Deaconess Medical Center
University of Arizona
Investigators
Principal Investigator: Emir Festic, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Emir Festic, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01783821     History of Changes
Other Study ID Numbers: 12-008192
Study First Received: January 31, 2013
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Acute respiratory distress syndrome (ARDS)

Additional relevant MeSH terms:
Acute Lung Injury
Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Budesonide
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 21, 2014