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Trial record 24 of 857 for:    ALBUTEROL

Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study (OARS)

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ClinicalTrials.gov Identifier: NCT01196377
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Donald H Arnold, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Asthma
Intervention Drug: Albuterol
Enrollment 16
Recruitment Details We recruited 16 patients ages 5 to 17 years for this double blind randomized trial.
Pre-assignment Details  
Arm/Group Title Nebulized Albuterol 10mg/hr Continuous 10mg/hr Pulsed 25mg/hr Continuous 25mg/hr Pulsed
Hide Arm/Group Description Active control arm, 10mg/hr continuous. Experimental 10mg/hr pulsed albuterol regimen. Experimental 25mg/hr continuous albuterol. Experimental 25mg/hr pulsed
Period Title: Overall Study
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Arm/Group Title Nebulized Albuterol 10mg/hr Continuous 10mg/hr Pulsed 25mg/hr Continuous 25mg/hr Pulsed Total
Hide Arm/Group Description Active control arm, 10mg/hr continuous. Experimental 10mg/hr pulsed albuterol regimen. Experimental 25mg/hr continuous albuterol. Experimental 25mg/hr pulsed Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
7.8  (2) 7.9  (2) 7.6  (4) 7.7  (2) 7.7  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
Female
2
  50.0%
2
  50.0%
2
  50.0%
2
  50.0%
8
  50.0%
Male
2
  50.0%
2
  50.0%
2
  50.0%
2
  50.0%
8
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
4 4 4 4 16
1.Primary Outcome
Title %FEV1
Hide Description % predicted forced expiratory volume in 1-second as a measure of airway obstruction
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebulized Albuterol 10mg/hr Continuous 10mg/hr Pulsed 25mg/hr Continuous 25mg/hr Pulsed
Hide Arm/Group Description:

Active control arm, 10mg/hr continuous.

Albuterol: Nebulized albuterol

Experimental 10mg/hr pulsed albuterol regimen.

Albuterol: Nebulized albuterol

Experimental 25mg/hr continuous albuterol.

Albuterol: Nebulized albuterol

Experimental 25mg/hr pulsed

Albuterol: Nebulized albuterol

Overall Number of Participants Analyzed 4 4 4 4
Mean (Full Range)
Unit of Measure: %-predicted
Baseline, pretreatment
20
(17 to 25)
34
(19 to 41)
26
(16 to 36)
31
(14 to 41)
2-hours (post-treatment)
41
(32 to 48)
47
(17 to 77)
67
(61 to 73)
44
(34 to 55)
Time Frame 2 hours
Adverse Event Reporting Description Report is to data safety and monitoring committee and IRB.
 
Arm/Group Title Nebulized Albuterol 10mg/hr Continuous 10mg/hr Pulsed 25mg/hr Continuous 25mg/hr Pulsed
Hide Arm/Group Description Active control arm, 10mg/hr continuous. Experimental 10mg/hr pulsed albuterol regimen. Experimental 25mg/hr continuous albuterol. Experimental 25mg/hr pulsed
All-Cause Mortality
Nebulized Albuterol 10mg/hr Continuous 10mg/hr Pulsed 25mg/hr Continuous 25mg/hr Pulsed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nebulized Albuterol 10mg/hr Continuous 10mg/hr Pulsed 25mg/hr Continuous 25mg/hr Pulsed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nebulized Albuterol 10mg/hr Continuous 10mg/hr Pulsed 25mg/hr Continuous 25mg/hr Pulsed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Limitations: small sample size and not powered to detect differences in outcomes (pilot feasibility study).
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
Layout table for Results Point of Contact information
Name/Title: Dr. Donald H Arnold
Organization: Vanderbilt University School of Medicine
Phone: 6155790516
EMail: don.arnold@vanderbilt.edu
Layout table for additonal information
Responsible Party: Donald H Arnold, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01196377     History of Changes
Other Study ID Numbers: 100725
K23HL080005 ( U.S. NIH Grant/Contract )
First Submitted: September 3, 2010
First Posted: September 8, 2010
Results First Submitted: December 10, 2014
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017