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Home > Studies > 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)

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

Dataset(s) Last Updated
January 3, 2018

Study Website
http://www.ardsnet.org/

Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT00434993

Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/21562125

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

Study Population

Subjects:

Albuterol: 152

Placebo: 130

Age:

 

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

 
Sex:
 

 

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

 
Race:

 

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

 

Available Biospecimens

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

Visits (Vials):

03/08/2021

  Plasma Urine Bronchial Lavage Total
Day 0 1,501 600 357 2,458
Day 3 1,627 932 210 2,769
Day 6 274 156 2 432
Day 12 159 3 0 162
Visits (Subjects):

03/08/2021

  Plasma
Total number of subjects Average volume (ml) per subject
Day 0 277 2.91
Day 3 250 3.22
Day 6 55 4.58
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 1.71
Day 3 61 1.76
Day 6 1 1.90
 

Please note that researchers must be registered on this site to submit a request, and you will be prompted to log in. If you are not registered on this site, you can do so via the Request button. Registration is quick, easy and free.

Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (15)

Materials Available

  • Bronchial Lavage
  • Plasma
  • Urine
  • More Details

Study Documents

  • PDF Data Dictionary (PDF - 5.1 MB)
  • PDF Forms (PDF - 1.2 MB)
  • PDF Protocol (PDF - 910.5 KB)

Persons using assistive technology may not be able to fully access information in the study documents. For assistance, Contact BioLINCC and include the web address and/or publication title in your message. If you need help accessing information in different file formats such as PDF, XLS, DOC, see Instructions for Downloading Viewers and Players.

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