Randomized, placebo-controlled clinical trial of an aerosolized β2-agonist for treatment of acute lung injury

Matthay, Michael A., Brower, Roy G., Carson, Shannon, Douglas, Ivor S., Eisner, Mark, Hite, Duncan, Holets, Steven, Kallet, Richard H., Liu, Kathleen D., MacIntyre, Neil, Moss, Marc, Schoenfeld, David, Steingrub, Jay, Thompson, B. Taylor, Hudson, L., Hough, C., Neff, M., Sims, K., Watkins, T., Steingrub, J., Tidswell, M., DeSouza, L., Kardos, C., Kozikowski, L., Kozikowski, K., Guntupalli, K., Bandi, V., Pope, C., Brower, R., Fessler, H., Hager, D., Mendez-Tellez, P., Oakjones, K., Needham, D., Sevransky, J., Workneh, A., Han, S., Murray, S., Shanholtz, C., Netzer, G., Rock, P., Sampaio, A., Titus, J., Harrington, T., Herr, D., Lee, B., Bolouri, N., Wiedemann, H. P., Ashton, R. W., Culver, D. A., Frederick, T., Komara, J. J., Guzman, J. A., Reddy, A. J., Hejal, R., Andrews, M., Haney, D., Lasalvia, S., Thornton, J. D., Warren, E. L., Moss, M., Benson, A., Burnham, E., Clark, B., Gray, L., Higgins, C., Maloney, B. J., Mealer, M., Frankel, S., Bost, T., Dennen, P., Hodgin, K., Douglas, I., Overdier, K., Thompson, K., Wolken, R., MacIntyre, N., Brown, L., Cox, C., Gentile, M., Govert, J., Knudsen, N., Carson, S., Chang, L., Lanier, J., Wheeler, A. P., Bernard, G. R., Hays, M., Mogan, S., Rice, T., Hite, R. D., Morris, P. E., Howard, A., Harvey, A., Bender, K., Wright, P., Gross, S., McLean, J., Overton, A., Truwit, J., Enfield, K., Marshall, M., Clemmer, T., Weaver, L., Zenger, M., Krueger, J., Morris, A., Ahmed, A., Austin, A., Dean, N., Grissom, C., Hirshberg, E., Kumar, N., Miller, R., Napoli, L., Orme, J., Pandita, S., Schreiber, G., Struck, L., Thomas, F., Thomsen, G., Lawton, C., Leung, F., Kim, P., Fujii, T., Baughman, J., Kerwin, B., Hanselman, D., Sundar, K., Alward, W., Hill, T., Campbell, E., Ludwig, K., Nielsen, D., Pearce, M., Matthay, M. A., Calfee, C., Daniel, B., Eisner, M., Garcia, O., Johnson, E., Kallet, R., Kordesch, K., Liu, K., Zhou, H., Peterson, M. W., Blaauw, J., Albertson, T., Vlastelin, E., Hubmayr, R., Brown, D., Gajic, O., Hinds, R., Holets, S., Kor, D. J., Passe, M., Deboisblanc, B., Lauto, P., Romaine, C., Meyaski, G., Hunt, J., Marr, A., Long, Earl K., Brierre, S., LeBlanc, C., Taylor, D., Jain, S., Seoane, L., Simeone, F., Fearon, J., Duchesne, J., Schoenfeld, D., Aquino, M., Dorer, D., Guha, M., Hammond, E., Lavery, N., Lazar, P., Molina, I., Morse, R., Oldmixon, C., Rawal, B., Ringwood, N., Shui, A., Smoot, E., Thompson, B. T., Harabin, A., Bredow, S., Waclawiw, M., Weinmann, G., Spragg, R. G., Slutsky, A., Levy, M., Markovitz, B., Petkova, E., Weijer, C., Sznajder, J., Begg, M., Israel, E., Lewis, J. and Parsons, P. (2011) Randomized, placebo-controlled clinical trial of an aerosolized β2-agonist for treatment of acute lung injury. American Journal of Respiratory and Critical Care Medicine, 184 5: 561-568. doi:10.1164/rccm.201012-2090OC


Author Matthay, Michael A.
Brower, Roy G.
Carson, Shannon
Douglas, Ivor S.
Eisner, Mark
Hite, Duncan
Holets, Steven
Kallet, Richard H.
Liu, Kathleen D.
MacIntyre, Neil
Moss, Marc
Schoenfeld, David
Steingrub, Jay
Thompson, B. Taylor
Hudson, L.
Hough, C.
Neff, M.
Sims, K.
Watkins, T.
Steingrub, J.
Tidswell, M.
DeSouza, L.
Kardos, C.
Kozikowski, L.
Kozikowski, K.
Guntupalli, K.
Bandi, V.
Pope, C.
Brower, R.
Fessler, H.
Hager, D.
Mendez-Tellez, P.
Oakjones, K.
Needham, D.
Sevransky, J.
Workneh, A.
Han, S.
Murray, S.
Shanholtz, C.
Netzer, G.
Rock, P.
Sampaio, A.
Titus, J.
Harrington, T.
Herr, D.
Lee, B.
Bolouri, N.
Wiedemann, H. P.
Ashton, R. W.
Culver, D. A.
Frederick, T.
Komara, J. J.
Guzman, J. A.
Reddy, A. J.
Hejal, R.
Andrews, M.
Haney, D.
Lasalvia, S.
Thornton, J. D.
Warren, E. L.
Moss, M.
Benson, A.
Burnham, E.
Clark, B.
Gray, L.
Higgins, C.
Maloney, B. J.
Mealer, M.
Frankel, S.
Bost, T.
Dennen, P.
Hodgin, K.
Douglas, I.
Overdier, K.
Thompson, K.
Wolken, R.
MacIntyre, N.
Brown, L.
Cox, C.
Gentile, M.
Govert, J.
Knudsen, N.
Carson, S.
Chang, L.
Lanier, J.
Wheeler, A. P.
Bernard, G. R.
Hays, M.
Mogan, S.
Rice, T.
Hite, R. D.
Morris, P. E.
Howard, A.
Harvey, A.
Bender, K.
Wright, P.
Gross, S.
McLean, J.
Overton, A.
Truwit, J.
Enfield, K.
Marshall, M.
Clemmer, T.
Weaver, L.
Zenger, M.
Krueger, J.
Morris, A.
Ahmed, A.
Austin, A.
Dean, N.
Grissom, C.
Hirshberg, E.
Kumar, N.
Miller, R.
Napoli, L.
Orme, J.
Pandita, S.
Schreiber, G.
Struck, L.
Thomas, F.
Thomsen, G.
Lawton, C.
Leung, F.
Kim, P.
Fujii, T.
Baughman, J.
Kerwin, B.
Hanselman, D.
Sundar, K.
Alward, W.
Hill, T.
Campbell, E.
Ludwig, K.
Nielsen, D.
Pearce, M.
Matthay, M. A.
Calfee, C.
Daniel, B.
Eisner, M.
Garcia, O.
Johnson, E.
Kallet, R.
Kordesch, K.
Liu, K.
Zhou, H.
Peterson, M. W.
Blaauw, J.
Albertson, T.
Vlastelin, E.
Hubmayr, R.
Brown, D.
Gajic, O.
Hinds, R.
Holets, S.
Kor, D. J.
Passe, M.
Deboisblanc, B.
Lauto, P.
Romaine, C.
Meyaski, G.
Hunt, J.
Marr, A.
Long, Earl K.
Brierre, S.
LeBlanc, C.
Taylor, D.
Jain, S.
Seoane, L.
Simeone, F.
Fearon, J.
Duchesne, J.
Schoenfeld, D.
Aquino, M.
Dorer, D.
Guha, M.
Hammond, E.
Lavery, N.
Lazar, P.
Molina, I.
Morse, R.
Oldmixon, C.
Rawal, B.
Ringwood, N.
Shui, A.
Smoot, E.
Thompson, B. T.
Harabin, A.
Bredow, S.
Waclawiw, M.
Weinmann, G.
Spragg, R. G.
Slutsky, A.
Levy, M.
Markovitz, B.
Petkova, E.
Weijer, C.
Sznajder, J.
Begg, M.
Israel, E.
Lewis, J.
Parsons, P.
Title Randomized, placebo-controlled clinical trial of an aerosolized β2-agonist for treatment of acute lung injury
Formatted title
Randomized, placebo-controlled clinical trial of an aerosolized β2-agonist for treatment of acute lung injury
Journal name American Journal of Respiratory and Critical Care Medicine   Check publisher's open access policy
ISSN 1073-449X
1535-4970
Publication date 2011-09-01
Sub-type Article (original research)
DOI 10.1164/rccm.201012-2090OC
Open Access Status Not yet assessed
Volume 184
Issue 5
Start page 561
End page 568
Total pages 8
Place of publication New York, United States
Publisher American Thoracic Society
Language eng
Formatted abstract
Rationale: β2-Adrenergic receptor agonists accelerate resolution of pulmonary edema in experimental and clinical studies.

Objectives: This clinical trial was designed to test the hypothesis that an aerosolized β2-agonist, albuterol, would improve clinical outcomes in patients with acute lung injury (ALI).

Methods: We conducted a multicenter, randomized, placebo-controlled clinical trial in which 282 patients with ALI receiving mechanical ventilation were randomized to receive aerosolized albuterol (5 mg) or saline placebo every 4 hours for up to 10 days. The primary outcome variable for the trial was ventilator-free days.

Measurements and Main Results: Ventilator-free days were not significantly different between the albuterol and placebo groups (means of 14.4 and 16.6 d, respectively; 95% confidence interval for the difference, −4.7 to 0.3 d; P = 0.087). Rates of death before hospital discharge were not significantly different between the albuterol and placebo groups (23.0 and 17.7%, respectively; 95% confidence interval for the difference, −4.0 to 14.7%; P = 0.30). In the subset of patients with shock before randomization, the number of ventilator-free days was lower with albuterol, although mortality was not different. Overall, heart rates were significantly higher in the albuterol group by approximately 4 beats/minute in the first 2 days after randomization, but rates of new atrial fibrillation (10% in both groups) and other cardiac dysrhythmias were not significantly different.

Conclusions: These results suggest that aerosolized albuterol does not improve clinical outcomes in patients with ALI. Routine use of β2-agonist therapy in mechanically ventilated patients with ALI cannot be recommended.
Keyword Acute respiratory distress syndrome
Alveolar epithelium
Pulmonary edema
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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