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

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01196377
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 16
• Arms: 4
• Duration (Days): 30

Study Details

Study Description

Brief Summary

Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

Condition or Disease	Intervention/Treatment	Phase
Acute Asthma	Drug: Albuterol	N/A

Detailed Description

The objective of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in randomly permuted blocks of four. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nebulized albuterol 10mg/hr continuous Active control arm, 10mg/hr continuous.	Drug: Albuterol; Nebulized albuterol; Other Names: proventil
Experimental: 10mg/hr pulsed Experimental 10mg/hr pulsed albuterol regimen.	Drug: Albuterol; Nebulized albuterol; Other Names: proventil
Experimental: 25mg/hr continuous Experimental 25mg/hr continuous albuterol.	Drug: Albuterol; Nebulized albuterol; Other Names: proventil
Experimental: 25mg/hr pulsed Experimental 25mg/hr pulsed albuterol	Drug: Albuterol; Nebulized albuterol; Other Names: proventil

Outcome Measures

Primary Outcome Measures

1. %FEV1 [2 hours]

   % predicted forced expiratory volume in 1-second as a measure of airway obstruction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Doctor diagnosed asthma

• Acute asthma exacerbation

• Treatment with systemic corticosteroids and nebulized albuterol

• Ages 5 to 17 years

Exclusion Criteria:

• Other acute or chronic lung disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Vanderbilt University Medical Center
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Donald H Arnold, MD, MPH, Vanderbilt University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Donald H Arnold, Associate Professor of Pediatrics and Emergency Medicine, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT01196377
• Other Study ID Numbers: 100725; K23HL080005
• First Posted: Sep 8, 2010
• Last Update Posted: Sep 29, 2017
• Last Verified: Sep 1, 2017

• Keywords provided by Donald H Arnold, Associate Professor of Pediatrics and Emergency Medicine, Vanderbilt University Medical Center: Asthma; Acute asthma; Pediatrics
• Additional relevant MeSH terms: Asthma; Albuterol

Study Results

Participant Flow

Recruitment Details	We recruited 16 patients ages 5 to 17 years for this double blind randomized trial.

Arm/Group Title	Nebulized Albuterol 10mg/hr Continuous	10mg/hr Pulsed	25mg/hr Continuous	25mg/hr Pulsed
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

Baseline Characteristics

Arm/Group Title	Nebulized Albuterol 10mg/hr Continuous	10mg/hr Pulsed	25mg/hr Continuous	25mg/hr Pulsed	Total
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 Participants	4	4	4	4	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.8 (2)	7.9 (2)	7.6 (4)	7.7 (2)	7.7 (2)
Sex: Female, Male (Count of Participants)
Female	2 50%	2 50%	2 50%	2 50%	8 50%
Male	2 50%	2 50%	2 50%	2 50%	8 50%
Region of Enrollment (participants) [Number]
United States	4 100%	4 100%	4 100%	4 100%	16 100%

Outcome Measures

1. Primary Outcome

Title	%FEV1
Description	% predicted forced expiratory volume in 1-second as a measure of airway obstruction
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nebulized Albuterol 10mg/hr Continuous	10mg/hr Pulsed	25mg/hr Continuous	25mg/hr Pulsed
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
Measure Participants	4	4	4	4
Baseline, pretreatment	20	34	26	31
2-hours (post-treatment)	41	47	67	44

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)		0/4 (0%)		0/4 (0%)
Serious Adverse Events
	Nebulized Albuterol 10mg/hr Continuous		10mg/hr Pulsed		25mg/hr Continuous		25mg/hr Pulsed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)		0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Nebulized Albuterol 10mg/hr Continuous		10mg/hr Pulsed		25mg/hr Continuous		25mg/hr Pulsed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)		0/4 (0%)		0/4 (0%)

Limitations/Caveats

Limitations: small sample size and not powered to detect differences in outcomes (pilot feasibility study).

More Information

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.