AsthmaNCT02073747
The Various Effects of Gaseous Albuterol on Serum Lactate
A study testing Normal Saline and Albuterol in people with Asthma, run by University Medical Center of Southern Nevada at 1 site in United States.
Trial summary
Empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy. It is not clear if this increased serum lactate is in response to a physiological response to the asthmatic process or from the albuterol treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Normal Saline and Albuterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Aug 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
Who cannot join
- Pregnant
- Prisoner
- beta agonist allergy
- hypokalemia
- taking furosemide, insulin, thiazide diuretics, metformin or acetazolamide
- coronary artery disease
Show all 10Show fewer
- hyperthyroidism
- abnormal heart rhythm
- baseline serum lactate level >2.2 mmol/L
- baseline heart rate > 120
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
About this study
Empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy.
It is not clear if this increased serum lactate is in response to a physiological response to the asthmatic process or from the albuterol treatment.
This study is designed to determine if administration of inhaled albuterol increases serum lactate in healthy subjects.
Read the detailed description
Approximately 30 healthy volunteers will be randomized to Albuterol or placebo. We powered our study to detect a difference of 0.5 mmol/L, but hypothesize that the difference will be greater than 1.0 mmol/L.
All volunteer subjects will sign a written consent, approved by the Institutional Review Board. The intended pool of volunteers will be from residents, attendings, and medical students in the hospital. The consent form will clearly specify that their participation in the study will not impact their academic status or employment.
The subjects randomized to the Albuterol arm will receive a one hour 10 mg continuous Albuterol nebulizer treatment. Those randomized to placebo will receive a one-hour saline nebulizer treatment. The chief pharmacist for the study will randomly assign a number between one and thirty to fifteen Albuterol treatments and fifteen placebo treatments.
Subjects will be monitored with cardiac monitor and serum lactate levels will be drawn every 15 minutes.
- Conditions
- Asthma
- Being tested
- Normal Saline, Albuterol
- Keywords
- Albuterol, Serum Lactate, Lactic Acidosis, Asthma
- Medical subject headings
- Asthma, Acidosis, Lactic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Also called NS, Saline
One hour inhaled normal saline
AlbuterolDrug
Also called Ventilin, Proventil
One hour inhaled ten milligrams of albuterol
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Control Group | Placebo comparator | Control group will be administered a one hour normal saline inhaled treatment. Receives: Drug: Normal Saline |
| Albuterol Trial Group | Active comparator | Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol Receives: Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.
We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.
Measured: Change in serum lactate from baseline to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionAug 2015
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center of Southern Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Anthony Zitek, University Medical Center of Southern Nevada
- Investigators
- Tony Zitek, MD, Principal investigator, Emergency Medicine Residency Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073747
- Sponsor's protocol ID
- EM 2014.01
- Status last verified
- Jul 2017
- First submitted
- 19 Feb 2014
- Last updated
- 14 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No IPD will be shared.
Publications
Appel D, Rubenstein R, Schrager K, Williams MH Jr. Lactic acidosis in severe asthma. Am J Med. 1983 Oct;75(4):580-4. doi: 10.1016/0002-9343(83)90436-9.
PubMed 6414303Roncoroni AJ, Adrougue HJ, De Obrutsky CW, Marchisio ML, Herrera MR. Metabolic acidosis in status asthmaticus. Respiration. 1976;33(2):85-94. doi: 10.1159/000193721.
PubMed 778959Manthous CA. Lactic acidosis in status asthmaticus : three cases and review of the literature. Chest. 2001 May;119(5):1599-602. doi: 10.1378/chest.119.5.1599.
PubMed 11348975Maury E, Ioos V, Lepecq B, Guidet B, Offenstadt G. A paradoxical effect of bronchodilators. Chest. 1997 Jun;111(6):1766-7. doi: 10.1378/chest.111.6.1766.
PubMed 9187208Chaulier K, Chalumeau S, Ber CE, Bret M, Rimmele T. [Metabolic acidosis in a context of acute severe asthma]. Ann Fr Anesth Reanim. 2007 Apr;26(4):352-5. doi: 10.1016/j.annfar.2007.01.016. Epub 2007 Mar 8. French.
PubMed 17349773Rodrigo GJ, Rodrigo C. Elevated plasma lactate level associated with high dose inhaled albuterol therapy in acute severe asthma. Emerg Med J. 2005 Jun;22(6):404-8. doi: 10.1136/emj.2003.012039.
PubMed 15911945
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Various Effects of Gaseous Albuterol on Serum Lactate
- ClinicalTrials.gov ID
- NCT02073747
- Acronym / sponsor ID
- EM 2014.01
- Conditions
- Asthma
- Keywords
- Albuterol, Serum Lactate, Lactic Acidosis, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Medical Center of Southern NevadaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Posted 14 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy.
It is not clear if this increased serum lactate is in response to a physiological response to the asthmatic process or from the albuterol treatment.
This study is designed to determine if administration of inhaled albuterol increases serum lactate in healthy subjects.
Detailed description
Approximately 30 healthy volunteers will be randomized to Albuterol or placebo. We powered our study to detect a difference of 0.5 mmol/L, but hypothesize that the difference will be greater than 1.0 mmol/L.
All volunteer subjects will sign a written consent, approved by the Institutional Review Board. The intended pool of volunteers will be from residents, attendings, and medical students in the hospital. The consent form will clearly specify that their participation in the study will not impact their academic status or employment.
The subjects randomized to the Albuterol arm will receive a one hour 10 mg continuous Albuterol nebulizer treatment. Those randomized to placebo will receive a one-hour saline nebulizer treatment. The chief pharmacist for the study will randomly assign a number between one and thirty to fifteen Albuterol treatments and fifteen placebo treatments.
Subjects will be monitored with cardiac monitor and serum lactate levels will be drawn every 15 minutes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Control Group | Placebo comparator | Drug: Normal SalineControl group will be administered a one hour normal saline inhaled treatment. |
| Albuterol Trial Group | Active comparator | Drug: AlbuterolTrial group to be administered one hour treatment of ten milligrams of inhaled albuterol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older
Key exclusion criteria (10 listed)
- Pregnant
- Prisoner
- beta agonist allergy
- hypokalemia
- taking furosemide, insulin, thiazide diuretics, metformin or acetazolamide
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 |
|---|---|---|
| Normal SalineAlso: NS, SalineOne hour inhaled normal saline | Drug | Normal Saline Control Group |
| AlbuterolAlso: Ventilin, ProventilOne hour inhaled ten milligrams of albuterol | Drug | Albuterol Trial Group |
Primary outcome
Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.
Time frame: Change in serum lactate from baseline to 1 hour
We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6414303Appel D, Rubenstein R, Schrager K, Williams MH Jr. Lactic acidosis in severe asthma. Am J Med. 1983 Oct;75(4):580-4. doi: 10.1016/0002-9343(83)90436-9.
- Background: PubMed 778959Roncoroni AJ, Adrougue HJ, De Obrutsky CW, Marchisio ML, Herrera MR. Metabolic acidosis in status asthmaticus. Respiration. 1976;33(2):85-94. doi: 10.1159/000193721.
- Background: PubMed 11348975Manthous CA. Lactic acidosis in status asthmaticus : three cases and review of the literature. Chest. 2001 May;119(5):1599-602. doi: 10.1378/chest.119.5.1599.
- Background: PubMed 9187208Maury E, Ioos V, Lepecq B, Guidet B, Offenstadt G. A paradoxical effect of bronchodilators. Chest. 1997 Jun;111(6):1766-7. doi: 10.1378/chest.111.6.1766.
- Background: PubMed 17349773Chaulier K, Chalumeau S, Ber CE, Bret M, Rimmele T. [Metabolic acidosis in a context of acute severe asthma]. Ann Fr Anesth Reanim. 2007 Apr;26(4):352-5. doi: 10.1016/j.annfar.2007.01.016. Epub 2007 Mar 8. French.
- Background: PubMed 15911945Rodrigo GJ, Rodrigo C. Elevated plasma lactate level associated with high dose inhaled albuterol therapy in acute severe asthma. Emerg Med J. 2005 Jun;22(6):404-8. doi: 10.1136/emj.2003.012039.
- Individual participant dataSharing planned: No. No IPD will be shared.
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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.
Tony Zitek, MD principal investigator
Emergency Medicine Residency Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline and Albuterol in people with Asthma, run by University Medical Center of Southern Nevada 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 1 inclusion and 10 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 Aug 2017. 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. Some participants in this study may receive a placebo. 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 14 Aug 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?
Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment. (time frame: Change in serum lactate from baseline to 1 hour). 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 NCT02073747, which also lists 6 linked publications.
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 Aug 2017.