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)

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
http://clinicaltrials.gov/ct2/sh...

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

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

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):

12/05/2016

	Plasma	Urine	Bronchial Lavage	Total
Day 0	2,070	598	416	3,084
Day 3	1,933	935	246	3,114
Day 6	312	142	2	456
Day 12	156	3	0	159

Visits (Subjects):

12/05/2016

	Plasma
	Total number of subjects	Average volume (ml) per subject
Day 0	277	3.50
Day 3	250	3.54
Day 6	55	4.98
Day 12	26	5.72

	Urine
	Total number of subjects	Average volume (ml) per subject
Day 0	265	3.72
Day 3	236	6.36
Day 6	49	4.69
Day 12	1	4.15

	Bronchial Lavage
	Total number of subjects	Average volume (ml) per subject
Day 0	99	2.31
Day 3	61	2.42
Day 6	1	1.90

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Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (4)

Materials Available

BRONCHIAL LAVAGE
PLASMA
URINE

More Details

Study Documents

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