Acute Respiratory Distress Network (ARDSNet) Studies 06 and 08 Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo for the Treatment of Acute Lung Injury (ALTA)
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Accession Number
HLB01051313a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
See bottom of this webpage for request information
Study Period
August 2007 – November 2008
NHLBI Division
DLD
Date Prepared
November 17, 2009
Last Updated
September 4, 2013
Clinical Trial URLs
https://clinicaltrials.gov/ct2/sho…
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubme…
Study Website
http://www.ardsnet.org/
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Commercial Use Specimen Restrictions No
Non-Genetic Use Specimen Restrictions Based On Area Of Use Yes
Genetic Use Of Specimens Allowed? Yes, For Some Specimens
Genetic Use Area Of Research Restrictions Yes
Specific Consent Restrictions
Non-genetic use of biospecimens is restricted to research involving lung injury, other lung disease or critical care diseases. Use of biospecimens in genetic research is tiered to (1) research in acute respiratory distress syndrome (ARDS), or (2) research in other medical conditions.
Objectives
This clinical trial was designed to test the hypothesis that an aerosolized beta-2-agonist, albuterol, would improve clinical outcomes in patients with acute lung injury (ALI) and acute respiratory distress syndrome (ARDS).
Background
In patients with acute lung injury and acute respiratory distress syndrome (ALI/ARDS), inflammation of the pulmonary circulation increases vascular permeability. Fluid leaks from blood vessels into the pulmonary interstitium and alveoli. Recovery from this form of acute respiratory failure requires that the pulmonary edema resolve. The resolution of alveolar edema is driven by active transport of sodium and chloride ions from the luminal space across both type I and type II alveolar epithelial cells, creating an osmotic gradient for the reabsorption of water. In the ex vivo human lung, the rate of alveolar fluid clearance can be doubled by treatment with a cyclic AMP beta-2 adrenergic receptor agonist.
On the basis of the preclinical observations that treatment with beta-2-agonists could reduce pulmonary edema and accelerate the rate of alveolar fluid clearance, the ALTA study was designed and undertaken with the hypothesis that treatment of patients with ALI/ARDS with beta-agonist therapy would accelerate the resolution of alveolar edema and improve clinical outcomes.
Subjects
282 ALI/ARDS patients that were intubated and receiving mechanical ventilation, had bilateral pulmonary infiltrates consistent with edema on frontal chest radiograph, had a ratio of PaO2 to FiO2 (fraction of inspired oxygen) of 300 or less (adjusted for altitude as appropriate), and did not have clinical evidence of left atrial hypertension.
Design
Study staff conducted a multicenter, randomized, placebo-controlled clinical trial in which subjects 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.
Conclusions
Ventilator-free days were not significantly different between the albuterol and placebo groups. The results suggest that aerosolized albuterol does not improve clinical outcomes in patients with ALI. Routine use of beta-2 agonist therapy in mechanically ventilated patients with ALI cannot be recommended (Am J Respir Crit Care Med. 2011; 184(5): 561-8).
Additional Details
Albuterol: 152
Placebo: 130
|
|
Albuterol |
Placebo |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
17-20 |
5 |
3.29 |
4 |
3.08 |
9 |
3.19 |
|
21-25 |
5 |
3.29 |
8 |
6.15 |
13 |
4.61 |
|
26-30 |
10 |
6.58 |
6 |
4.62 |
16 |
5.67 |
|
31-35 |
5 |
3.29 |
4 |
3.08 |
9 |
3.19 |
|
36-40 |
5 |
3.29 |
11 |
8.46 |
16 |
5.67 |
|
41-45 |
19 |
12.50 |
10 |
7.69 |
29 |
10.28 |
|
46-50 |
21 |
13.82 |
17 |
13.08 |
38 |
13.48 |
|
51-55 |
21 |
13.82 |
24 |
18.46 |
45 |
15.96 |
|
56-60 |
14 |
9.21 |
12 |
9.23 |
26 |
9.22 |
|
61-65 |
8 |
5.26 |
8 |
6.15 |
16 |
5.67 |
|
66-70 |
19 |
12.50 |
7 |
5.38 |
26 |
9.22 |
|
71-75 |
7 |
4.61 |
12 |
9.23 |
19 |
6.74 |
|
76-80 |
8 |
5.26 |
2 |
1.54 |
10 |
3.55 |
|
81-85 |
2 |
1.32 |
4 |
3.08 |
6 |
2.13 |
|
86-89 |
3 |
1.97 |
1 |
0.77 |
4 |
1.42 |
|
|
Albuterol |
Placebo |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
Female |
67 |
44.08 |
59 |
45.38 |
126 |
44.68 |
|
Male |
85 |
55.92 |
71 |
54.62 |
156 |
55.32 |
|
|
Albuterol |
Placebo |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
Unknown/Not Reported |
3 |
1.97 |
3 |
2.31 |
6 |
2.13 |
|
White |
115 |
75.66 |
102 |
78.46 |
217 |
76.95 |
|
Black |
26 |
17.11 |
20 |
15.38 |
46 |
16.31 |
|
Other |
8 |
5.26 |
5 |
3.85 |
13 |
4.61 |
|
|
Albuterol |
Placebo |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
Hispanic or Latino |
15 |
9.87 |
14 |
10.77 |
29 |
10.28 |
|
Not Hispanic or Latino |
137 |
90.13 |
116 |
89.23 |
253 |
89.72 |
Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process
06/15/2020
| Plasma | ||
|---|---|---|
| Total number of subjects | Average volume (ml) per subject | |
| Day 0 | 277 | 2.92 |
| Day 3 | 250 | 3.23 |
| Day 6 | 55 | 4.62 |
| Day 12 | 26 | 5.47 |
| Urine | ||
|---|---|---|
| Total number of subjects | Average volume (ml) per subject | |
| Day 0 | 265 | 3.71 |
| Day 3 | 236 | 6.19 |
| Day 6 | 49 | 4.49 |
| Day 12 | 1 | 4.15 |
| Bronchial Lavage | ||
|---|---|---|
| Total number of subjects | Average volume (ml) per subject | |
| Day 0 | 99 | 1.83 |
| Day 3 | 61 | 1.93 |
| Day 6 | 1 | 1.90 |
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Resources Available
Specimens and Study DatasetsMaterials Available
- Bronchial Lavage
- Plasma
- Urine
- More Details
Study Documents
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