Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434993
Status:
TERMINATED
Last Update Posted:
2017-02-10
First Post:
2007-01-29
Brief Title:
Drug Study of Albuterol to Treat Acute Lung Injury
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Prospective Randomized Multicenter Trial of Aerosolized Albuterol Versus Placebo in Acute Lung Injury
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped for futility by DSMB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALTA
Brief Summary:
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
Detailed Description:
Aerosolized beta-2 agonist therapy is anticipated to diminish the formation of lung edema enhance clearance of lung edema and decrease pulmonary inflammation in patients with acute lung injury Because beta-2 agonists have been shown to reduce permeability induced lung injury it is anticipated that the severity of lung injury will be reduced by aerosolized beta-2 agonist therapy The therapy may work by enhancing resolution of pulmonary edema by upregulating alveolar epithelial fluid transport mechanisms that will in turn enhance the clearance of alveolar edema A reduction in the severity of lung injury and the quantity of alveolar edema should result in earlier extubation and more ventilator free days improved pulmonary oxygen uptake and improved lung compliance
Study design phase IIIII prospective randomized double-blind placebo controlled trial
In Phase II patients will be treated with aerosolized albuterol 50 mg vs normal saline n40-50administered every 4 hours for 10 days following randomization or until 24 hours following extubation whichever occurs first The protocol stipulates that the 50 mg dose will be reduced to 25 mg if patients exceed defined heart rate limits
In Phase III the 50 mg dose will be used unless there is evidence that this dose has an unacceptable safety profile or dose reductions for tachycardia occur in a large fraction of patients In that case a lower dose of 25 mg will be used
Patients will be followed for 90 days or until discharge from the hospital to home with unassisted breathing whichever occurs first
Study design phase IIIII prospective randomized double-blind placebo controlled trial
In Phase II patients will be treated with aerosolized albuterol 50 mg vs normal saline n40-50administered every 4 hours for 10 days following randomization or until 24 hours following extubation whichever occurs first The protocol stipulates that the 50 mg dose will be reduced to 25 mg if patients exceed defined heart rate limits
In Phase III the 50 mg dose will be used unless there is evidence that this dose has an unacceptable safety profile or dose reductions for tachycardia occur in a large fraction of patients In that case a lower dose of 25 mg will be used
Patients will be followed for 90 days or until discharge from the hospital to home with unassisted breathing whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN268200536179C | None | None | None |
| N01 HR056179 | None | None | None |