Oxygen ConsumptionNCT02802111

Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

A study testing Albuterol and Levalbuterol in people with Oxygen Consumption, run by Children's Hospital Los Angeles.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction. Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Oxygen Consumption
What is being tested?: Albuterol and Levalbuterol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Jun 2015to Sep 2017
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers between the ages of 18 and 60 years

Who cannot join

Coronary artery disease, history of intolerance to beta agonists

About this study

Official title: Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison With Levalbuterol in Healthy Adult Volunteers

Read the detailed description

Inhaled β2 adrenoceptor agonists are frequently used to treat reversible lower airway obstruction, or to assist with mucociliary clearance. Albuterol remains the most commonly used β agonist and contains a racemic mixture of two enantiomers. The R enantiomer is the active moiety responsible for the bronchodilation, while the S enantiomer was initially thought to be inactive, although recent studies suggest otherwise. Levalbuterol contains the single R form enantiomer, and in clinical practice it is frequently prescribed not only because of its bronchodilator benefits, but to limit cardiovascular toxicity. Adverse cardiovascular effects remain the main dose-limiting factor for β2 agonists. The primary objective of the investigators study is to compare the change in oxygen consumption following albuterol to that of levalbuterol, in healthy adult volunteers. The investigators hypothesized there would be no clinically significant difference in V'O2 between the two drugs, if equal doses of the R-enantiomer were administered. Secondary objectives were to compare the changes in heart rate and other vital signs between the two drugs.

Conditions: Oxygen Consumption
Being tested: Albuterol, Levalbuterol
Keywords: Beta Agonists, Asthma, Albuterol, Levalbuterol
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlbuterolDrug
Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
LevalbuterolDrug
Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention

Study groups in NCT02802111
Study group	Role	What they receive
Albuterol 5 mg first, then levalbuterol 2.5 mg	Experimental	Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention. Receives: Drug: Albuterol
Levalbuterol 2.5 mg first, then albuterol 5 mg	Experimental	Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention. Receives: Drug: Levalbuterol

What is being measured

The primary outcome is the main question the study is designed to answer.

Oxygen Consumption
Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol
Measured: 0 to 60 minutes

Secondary outcomes (1)

Heart Rate
Vital signs including heart rate will be measured for up to 60 minutes following beta agonist
Measured: 0 to 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Sep 2017

First posted16 Jun 2016 (estimated)
Study startJun 2015
Primary completionSep 2017
Study completionSep 2017

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 Oxygen ConsumptionStudies of the same condition, open and under way.
More trials run by Children's Hospital Los AngelesThe 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02802111
Sponsor's protocol ID: CCI-14-00101
Status last verified: Oct 2020
First submitted: 10 Jun 2016
Last updated: 28 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
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Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
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Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving Heart Failure With Preserved Ejection Fraction
HFpEF - Heart Failure With Preserved Ejection Fraction
RecruitingObservational study
Changes in Energy Expenditure in Response to Physical Activity in Healthy Adults
Physical Activities
Active, not recruitingPhase 1
Adaptive Training Recommendations for Improved Physical Performance
Maximal Oxygen Consumption, Physical Performance

All Oxygen Consumption trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison With Levalbuterol in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT02802111
Acronym / sponsor ID: CCI-14-00101
Conditions: Oxygen Consumption
Keywords: Beta Agonists, Asthma, Albuterol, Levalbuterol
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Children's Hospital Los AngelesUniversity, hospital or other
Study start: Jun 2015
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 16 Jun 2016 (estimated)
Results: Posted 28 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Albuterol 5 mg first, then levalbuterol 2.5 mg	Experimental	Drug: AlbuterolPatient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Levalbuterol 2.5 mg first, then albuterol 5 mg	Experimental	Drug: LevalbuterolPatient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy volunteers between the ages of 18 and 60 years

Key exclusion criteria (1 listed)

Coronary artery disease, history of intolerance to beta agonists

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
AlbuterolPatient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.	Drug	Albuterol 5 mg first, then levalbuterol 2.5 mg
LevalbuterolPatient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention	Drug	Levalbuterol 2.5 mg first, then albuterol 5 mg

Primary outcome

Oxygen Consumption
Time frame: 0 to 60 minutes
Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol

1 secondary outcome

Heart Rate
Time frame: 0 to 60 minutes

Results and safety

Results posted to the registry on 28 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Albuterol 5 mg First, Then Levalbuterol 2.5 mg	12	12
Levalbuterol 2.5 mg First, Then Albuterol 5 mg	12	12

Primary outcome: Oxygen Consumption

Time frame: 0 to 60 minutes. Median (Inter-Quartile Range). Unit: mls/kg/min

Measure	Albuterol 5 mg First, Then Levalbuterol 2.5 mg n = 24	Levalbuterol 2.5 mg First, Then Albuterol 5 mg n = 24
Value	.28 (.15 to .36)	.27 (.19 to .35)

Population analysed: Healthy volunteers, median age 32 years. The population is 24 individuals they are randomized to which bronchodilator they received first. Half were randomized to Albuterol and half to levalbuterol but each subject received both medication. It is a matter of which they received first. There was a four hour wash out period between the first and second medication.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: We observed the volunteers over 4 hours following use of either albuterol first or levalbuterol first then for another 4 hours following the second medication.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Albuterol 5 mg First, Then Levalbuterol 2.5 mg	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Levalbuterol 2.5 mg First, Then Albuterol 5 mg	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Oxygen Consumption

Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
Critically Ill Patients, Circulatory Shock
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving Heart Failure With Preserved Ejection Fraction
HFpEF - Heart Failure With Preserved Ejection Fraction
RecruitingObservational study
Changes in Energy Expenditure in Response to Physical Activity in Healthy Adults
Physical Activities
Active, not recruitingPhase 1
Adaptive Training Recommendations for Improved Physical Performance
Maximal Oxygen Consumption, Physical Performance

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.

Patrick A Ross, MD principal investigator

Children's Hospital Los Angeles

Questions about this trial

What is this clinical trial studying?

A study testing Albuterol and Levalbuterol in people with Oxygen Consumption, run by Children's Hospital Los Angeles.

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 1 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 28 Oct 2020. 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 28 Oct 2020). 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?

Oxygen Consumption (time frame: 0 to 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02802111.

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 28 Oct 2020.