Drug Study of Albuterol to Treat Acute Lung Injury

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require treatment that includes the use of a breathing machine (ventilator). The purpose of this study is to find out whether giving albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI or ARDS makes a difference in how long it takes for a patient to be able to breath without the ventilator.

Key facts

Study ID

NCT00434993

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

282

Starts

2007-08-01

Expected to finish

2008-11-01

Last updated by the study team

2017-02-10

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must meet the following three criteria within a 24-hour period:
• Acute onset of PaO2/FiO2 less than or equal to 300 (adjustments made for altitude where appropriate)
• Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
• Requirement for positive pressure ventilation via endotracheal tube
• No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates

You may not qualify if…

• Greater than 48 hours since all inclusion criteria are met
• Neuromuscular disease that impairs ability to ventilate without assistance, (e.g., cervical spinal cord injury at level C5 or higher spinal cord injury amyotrophic lateral sclerosis, Guillain-Barré syndrome or myasthenia gravis)
• Pregnant or breast-feeding
• Severe chronic respiratory disease (i.e., chronic hypercapnia [PaCO2 greater than 45 mmHg], chronic hypoxemia [PaO2 less than 55 mmHg on FiO2 = 0.21], hospitalization within the last 6 months for respiratory failure [PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mmHg on 0.21 FiO2], secondary polycythemia, severe pulmonary hypertension [mean PAP (pulmonary artery pressure) greater than 40 mmHg], or ventilator dependency)
• Burns over greater than 40% of total body surface area
• Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
• Allogeneic bone marrow transplant within the 5 years prior to study entry
• Participant, surrogate, or physician is not committed to full support (Exception: a participant will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
• Severe chronic liver disease (Child-Pugh score of 11-15)
• Diffuse alveolar hemorrhage from vasculitis
• Morbid obesity (greater than 1kg/cm body weight.)
• Unwillingness or inability to utilize the ARDS network 6 ml / kg Predicted Body Weight (PBW) ventilation protocol
• Moribund participant and is not expected to survive 24 hours
• No intent to obtain central venous access for monitoring intravascular pressures
• Contraindication to aerosolized albuterol (see Appendix A.8 of the protocol for more information)
• Daily use (prior to study hospitalization) of inhaled beta agonist, corticosteroid, or oral leukotriene modifier
• Unwillingness of primary physician to discontinue inpatient beta agonist use
• Acute myocardial infarction or acute coronary syndrome within 30 days of study entry
• Severe congestive heart failure (see Appendix A5 of the protocol for more information)
• Participation in other experimental medication trial within 30 days of study entry with the exception of the ARDSNet pharmaconutrient nutrition trial (OMEGA)
• Heart rate greater than 85% of maximal predicted heart rate (MHR85) as calculated by MHR85 = 85% x (220-age)
• Currently receiving high frequency ventilation

Where it is running

• University of San Francisco-Fresno Medical Center — Fresno, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• UCSF-Moffitt Hospital — San Francisco, California, United States
• UCSF-San Francisco General Hospital — San Francisco, California, United States
• Centura St. Anthony Central Hospital — Denver, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Baton Rouge General Hospital-Blue Bonnet — Baton Rouge, Louisiana, United States
• Baton Rouge General Hospital-Midcity — Baton Rouge, Louisiana, United States
• Earl K. Long Medical Center — Baton Rouge, Louisiana, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• Medical Center of Louisiana — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Baltimore VA Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Maryland Shock Trauma Center — Baltimore, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Rochester Methodist Hospital — Rochester, Minnesota, United States
• St. Mary's Hospital, Mayo Clinic — Rochester, Minnesota, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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