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Phase 2 N=61 Randomized Double-blind Prevention

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

Acute Respiratory Distress Syndrome (ARDS)

Bottom Line

View on ClinicalTrials.gov: NCT01783821 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio — 320; 334; 376; 336 SpO2/FiO2 Ratio — p=0.02

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Budesonide (Drug); Placebo (Drug); Formoterol (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
Jul 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio		 320; 334; 376; 336; 400; 332 0.02 sig
PRIMARY
Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio		 0; 8; 11; 9; 18; 13 0.01 sig
SECONDARY
Number of Subjects Who Needed Mechanical Ventilation		 6; 16 0.01 sig
SECONDARY
Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)		 0; 7 0.01 sig
SECONDARY
Hospital Length of Stay		 4; 8 0.02 sig
SECONDARY
Intensive Care Unit (ICU) Length of Stay		 4; 6 0.01 sig

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.

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 110/minute
  • Persistent sinus tachycardia of >130/minute despite early goal directed therapy with fluids, pressors, antibiotics and supplemental oxygen
  • Pregnant patients
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01783821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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