Acute AsthmaOARSNCT01196377
Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
A study testing Albuterol in people with Acute Asthma, run by Vanderbilt University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Acute Asthma
- What is being tested?
- Albuterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Doctor diagnosed asthma
- Acute asthma exacerbation
- Treatment with systemic corticosteroids and nebulized albuterol
- Ages 5 to 17 years
Who cannot join
- Other acute or chronic lung disease
About this study
Official title: Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
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.
Read the 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.
- Conditions
- Acute Asthma
- Being tested
- Albuterol
- Keywords
- Asthma, Acute asthma, Pediatrics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuterolDrug
Also called proventil
Nebulized albuterol
| Study group | Role | What they receive |
|---|---|---|
| Nebulized albuterol 10mg/hr continuous | Active comparator | Active control arm, 10mg/hr continuous. Receives: Drug: Albuterol |
| 10mg/hr pulsed | Experimental | Experimental 10mg/hr pulsed albuterol regimen. Receives: Drug: Albuterol |
| 25mg/hr continuous | Experimental | Experimental 25mg/hr continuous albuterol. Receives: Drug: Albuterol |
| 25mg/hr pulsed | Experimental | Experimental 25mg/hr pulsed albuterol Receives: Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
%FEV1
% predicted forced expiratory volume in 1-second as a measure of airway obstruction
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute AsthmaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Donald H Arnold, Vanderbilt University Medical Center
- Investigators
- Donald H Arnold, MD, MPH, Principal investigator, Vanderbilt University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196377
- Sponsor's protocol ID
- 100725
- Other IDs
- K23HL080005
- Acronym
- OARS
- Status last verified
- Sep 2017
- First submitted
- 3 Sep 2010
- Last updated
- 29 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
- ClinicalTrials.gov ID
- NCT01196377
- Acronym / sponsor ID
- OARS / 100725
- Conditions
- Acute Asthma
- Keywords
- Asthma, Acute asthma, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Posted 29 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nebulized albuterol 10mg/hr continuous | Active comparator | Drug: AlbuterolActive control arm, 10mg/hr continuous. |
| 10mg/hr pulsed | Experimental | Drug: AlbuterolExperimental 10mg/hr pulsed albuterol regimen. |
| 25mg/hr continuous | Experimental | Drug: AlbuterolExperimental 25mg/hr continuous albuterol. |
| 25mg/hr pulsed | Experimental | Drug: AlbuterolExperimental 25mg/hr pulsed albuterol |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Doctor diagnosed asthma
- Acute asthma exacerbation
- Treatment with systemic corticosteroids and nebulized albuterol
- Ages 5 to 17 years
Key exclusion criteria (1 listed)
- Other acute or chronic lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbuterolAlso: proventilNebulized albuterol | Drug | 10mg/hr pulsed, 25mg/hr continuous, 25mg/hr pulsed, Nebulized albuterol 10mg/hr continuous |
Primary outcome
%FEV1
Time frame: 2 hours
% predicted forced expiratory volume in 1-second as a measure of airway obstruction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald H Arnold, MD, MPH principal investigator
Vanderbilt University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Albuterol in people with Acute Asthma, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%FEV1 (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.