AsthmaPhase 4NCT00124176
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
A Phase 4 study testing Racemic albuterol (R+S albuterol) and Levalbuterol (R albuterol) in people with Asthma, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Racemic albuterol (R+S albuterol) and Levalbuterol (R albuterol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Feb 2006
- Phase
- Phase 4
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6-18 years of age
- Diagnosis of asthma with two previous visits to emergency department (ED) or primary care provider for asthma care
- Clinical decision by ED attending physician to begin continuous albuterol after standardized initial ED treatment.
Who cannot join
- Clinical decision to begin continuous intravenous beta-agonist infusion (e.g. terbutaline)
- Clinical decision to admit to the Pediatric Intensive Care Unit
- Drug allergy or other contraindication to RAC or LEV
- Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac disease
- Pregnancy
- Prior enrollment in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma.
Primary hypothesis
Read more
- Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol.
Secondary hypotheses
- Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.
- Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
Read the detailed description
High-dose nebulized albuterol is standard therapy for severe asthma exacerbations at The Children's Hospital of Philadelphia (CHOP) and other tertiary care pediatric hospitals throughout the United States. For the most severe exacerbations, albuterol is provided continuously at high doses until improvement is observed. This regimen has been standardized in a treatment protocol that has been used at CHOP for more than 5 years. Recently, levalbuterol (LEV), the purified active (R)-enantiomer of albuterol, has been approved for use in acute asthma. Preliminary evidence suggests that LEV may improve pulmonary function and clinical outcomes in children with asthma based on studies using standard dosing regimens. Laboratory and clinical evidence suggest that the (S)-enantiomer of albuterol may have detrimental effects that contribute to poor response to racemic albuterol (RAC). Limited data exist about the efficacy of LEV in high-dose regimens.
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of LEV compared to RAC when delivered continuously in a high-dose regimen for severe exacerbations of asthma. Children treated for asthma exacerbations in the CHOP emergency department (ED) will be eligible for study enrollment. Those that meet enrollment criteria will be randomized to receive either high dose RAC according to the standard asthma care protocol or equivalent dosing of LEV. Approximately 128 patients with 64 in each arm of the study will be enrolled. An interim safety analysis will be conducted after the first 40 patients are enrolled. This study should be completed in six to nine months. The primary outcome will be duration of continuous therapy. Secondary outcomes will include improvement of clinical asthma score and change in forced expiratory volume in one second (FEV1). In addition, (R)-albuterol and (S)-albuterol levels will be measured at study entry and at 6-hour intervals in the first 40 patients enrolled. These values will be used to determine prior RAC exposure and to determine serum levels of (R) and (S) albuterol during continuous therapy.
- Conditions
- Asthma
- Being tested
- Racemic albuterol (R+S albuterol), Levalbuterol (R albuterol)
- Keywords
- Asthma, Levalbuterol, Albuterol, Children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racemic albuterol (R+S albuterol)Drug
20mg/hr continuous racemic albuterol
Levalbuterol (R albuterol)Drug
Also called Xopenex
10mg/hr continuous nebulized levalbuterol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nebulized levalbuterol 10mg/hr given continuously Receives: Drug: Levalbuterol (R albuterol) |
| 2 | Active comparator | Racemic albuterol 20mg/hr given continuously Receives: Drug: Racemic albuterol (R+S albuterol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Continuous Therapy
standard intention to treat (ITT) analysis
Measured: During hospitalization
Secondary outcomes (4)
Change in Pediatric Asthma Severity Score
Change in Pediatric Asthma Severity Score. Range 0 (best) - 6 (worst)
Score at each time point is calculated by adding 3 elements:
Wheeze (0= None/Mild, 1=Moderate, 2=Severe) Prolonged expiration (0= None/Mild, 1=Moderate, 2=Severe) Work of breathing (0= None/Mild, 1=Moderate, 2=Severe)
Measured: After 12 hours of continuous nebulization
Heart Rate
Measured: After 12 hours of continuous nebulization
Serum Potassium Levels
Measured: After 12 hours of continuous nebulization
Serum Albuterol S Isomer Levels
Measured: After 6 hours of continuous albuterol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
- Study startApr 2004
- Primary completionFeb 2006
- Study completionFeb 2006
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 AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Joseph J Zorc, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124176
- Sponsor's protocol ID
- #2004-12-4130
- Status last verified
- Dec 2012
- First submitted
- 25 Jul 2005
- Last updated
- 14 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
- ClinicalTrials.gov ID
- NCT00124176
- Acronym / sponsor ID
- #2004-12-4130
- Conditions
- Asthma
- Keywords
- Asthma, Levalbuterol, Albuterol, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Apr 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 27 Jul 2005 (estimated)
- Results
- Posted 14 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma.
Primary hypothesis
- Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol.
Secondary hypotheses
- Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.
- Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
Detailed description
High-dose nebulized albuterol is standard therapy for severe asthma exacerbations at The Children's Hospital of Philadelphia (CHOP) and other tertiary care pediatric hospitals throughout the United States. For the most severe exacerbations, albuterol is provided continuously at high doses until improvement is observed. This regimen has been standardized in a treatment protocol that has been used at CHOP for more than 5 years. Recently, levalbuterol (LEV), the purified active (R)-enantiomer of albuterol, has been approved for use in acute asthma. Preliminary evidence suggests that LEV may improve pulmonary function and clinical outcomes in children with asthma based on studies using standard dosing regimens. Laboratory and clinical evidence suggest that the (S)-enantiomer of albuterol may have detrimental effects that contribute to poor response to racemic albuterol (RAC). Limited data exist about the efficacy of LEV in high-dose regimens.
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of LEV compared to RAC when delivered continuously in a high-dose regimen for severe exacerbations of asthma. Children treated for asthma exacerbations in the CHOP emergency department (ED) will be eligible for study enrollment. Those that meet enrollment criteria will be randomized to receive either high dose RAC according to the standard asthma care protocol or equivalent dosing of LEV. Approximately 128 patients with 64 in each arm of the study will be enrolled. An interim safety analysis will be conducted after the first 40 patients are enrolled. This study should be completed in six to nine months. The primary outcome will be duration of continuous therapy. Secondary outcomes will include improvement of clinical asthma score and change in forced expiratory volume in one second (FEV1). In addition, (R)-albuterol and (S)-albuterol levels will be measured at study entry and at 6-hour intervals in the first 40 patients enrolled. These values will be used to determine prior RAC exposure and to determine serum levels of (R) and (S) albuterol during continuous therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levalbuterol (R albuterol)Nebulized levalbuterol 10mg/hr given continuously |
| 2 | Active comparator | Drug: Racemic albuterol (R+S albuterol)Racemic albuterol 20mg/hr given continuously |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 6-18 years of age
- Diagnosis of asthma with two previous visits to emergency department (ED) or primary care provider for asthma care
- Clinical decision by ED attending physician to begin continuous albuterol after standardized initial ED treatment.
Key exclusion criteria (6 listed)
- Clinical decision to begin continuous intravenous beta-agonist infusion (e.g. terbutaline)
- Clinical decision to admit to the Pediatric Intensive Care Unit
- Drug allergy or other contraindication to RAC or LEV
- Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac disease
- Pregnancy
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 |
|---|---|---|
| Racemic albuterol (R+S albuterol)20mg/hr continuous racemic albuterol | Drug | 2 |
| Levalbuterol (R albuterol)Also: Xopenex10mg/hr continuous nebulized levalbuterol | Drug | 1 |
Primary outcome
Duration of Continuous Therapy
Time frame: During hospitalization
standard intention to treat (ITT) analysis
4 secondary outcomes
Change in Pediatric Asthma Severity Score
Time frame: After 12 hours of continuous nebulization
Heart Rate
Time frame: After 12 hours of continuous nebulization
Serum Potassium Levels
Time frame: After 12 hours of continuous nebulization
Serum Albuterol S Isomer Levels
Time frame: After 6 hours of continuous albuterol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
- 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.
Joseph J Zorc, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Racemic albuterol (R+S albuterol) and Levalbuterol (R albuterol) in people with Asthma, run by Children's Hospital of Philadelphia at 1 site in United States.
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 3 inclusion and 6 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 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2013). 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?
Duration of Continuous Therapy (time frame: During hospitalization). 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 14 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.