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Trial record 1 of 1 for:    NCT00434993
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Drug Study of Albuterol to Treat Acute Lung Injury (ALTA)

This study has been terminated.
(Stopped for futility by DSMB)
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00434993
First received: January 29, 2007
Last updated: June 7, 2013
Last verified: December 2012
Results First Received: December 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Respiratory Distress Syndrome, Adult
Interventions: Drug: Albuterol Sulfate
Procedure: Mini-Bronchoalveolar Lavage (BAL)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted with a combined Phase II/III design to enroll 1000 patients with a safety review performed after 100 subjects were enrolled and interim analysis looks at 250, 500, and 700 subjects. The first subject was entered in August 2007 and the last subject in July of 2008 when the study was stopped for futility at 282 enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Albuterol Sulfate Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
Placebo Preservative-free 0.9% sterile sodium chloride every 4 hours

Participant Flow:   Overall Study
    Albuterol Sulfate     Placebo  
STARTED     152     130  
COMPLETED     152     130  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized patients were analyzed.

Reporting Groups
  Description
Albuterol Sulfate Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
Placebo Preservative-free 0.9% sterile sodium chloride every 4 hours
Total Total of all reporting groups

Baseline Measures
    Albuterol Sulfate     Placebo     Total  
Number of Participants  
[units: participants]
  152     130     282  
Age  
[units: participants]
     
<=18 years     2     3     5  
Between 18 and 65 years     111     100     211  
>=65 years     39     27     66  
Age  
[units: years]
Mean ± Standard Deviation
  52.3  ± 16.4     50.9  ± 16.2     51.6  ± 16.2  
Gender  
[units: participants]
     
Female     67     59     126  
Male     85     71     156  
Region of Enrollment  
[units: participants]
     
United States     152     130     282  



  Outcome Measures
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1.  Primary:   Number of Ventilator Free Days (VFD)   [ Time Frame: Determined 28 days after a subject entered the study ]

2.  Secondary:   Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60   [ Time Frame: Determined 60 days after a subject entered the study ]

3.  Secondary:   Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90   [ Time Frame: Determined 90 days after a subject entered the study ]

4.  Secondary:   Number of ICU-free Days at 28 Days After Randomization   [ Time Frame: Determined 28 days after a subject entered the study ]

5.  Secondary:   Number of Organ Failure-free Days at Day 28 Following Randomization   [ Time Frame: Daily from baseline to study day 28 ]

6.  Secondary:   Ventilator Free Days to Day 28 in the Subset of Participants With ARDS   [ Time Frame: Determined 28 days after a subject entered the study ]

7.  Secondary:   Hospital Mortality to Day 60 in the Subset of Participants With ARDS   [ Time Frame: Determined 60 days after a subject entered the study ]

8.  Secondary:   Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock   [ Time Frame: Determined 28 days after a subject entered the study ]

9.  Secondary:   Hospital Mortality up to Day 60 in Subjects With Baseline Shock   [ Time Frame: Determined 60 days after a subject entered the study ]

10.  Secondary:   Plasma Levels of IL-6 and IL-8 on Study Day 3   [ Time Frame: Measured at baseline and 3 days after randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Schoenfeld, ARDSNet CCC PI
Organization: Acute Respiratory Distress Syndrome (ARDS) Network
phone: 617-726-6111
e-mail: dschoenfeld@partners.org


No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Publications automatically indexed to this study:

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00434993     History of Changes
Other Study ID Numbers: 474, N01 HR056179, HHSN268200536179C
Study First Received: January 29, 2007
Results First Received: December 4, 2012
Last Updated: June 7, 2013
Health Authority: United States: Federal Government