Is Levalbuterol an Effective Treatment With Less Cardiac Side Effects Than Albuterol in Hyperkalemia Patients: A Randomized-controlled Clinical Trial Protocol.

Hyperkalemia is a common life-threatening electrolyte disturbance which may impair cardiac and many other organs' functions. Unfortunately, a well-established guideline for the treatment of hyperkalemia in the emergency setting is still missing. However, the last "Kidney Disease: Improving Global Outcomes (KDIGO)" conference proposed a treatment protocol for hyperkalemia and addressed controversies in this matter. Beta2-agonists were one of the main lines in the approach towards managing a patient with hyperkalemia. However, this evidence was only available for racemic albuterol.
Levalbuterol is the isolated R-enantiomer of racemic albuterol which is comprised of S- and R-enantiomers. Several lab and clinical studies have assessed the effect, affinity, and selectivity of each of the enantiomers. Few studies in medical literature have compared the difference between these two drugs regarding cardiac effects with inconclusive results, and even fewer studies have compared the efficacies of these two drugs regarding potassium lowering effect.
To the investigators' knowledge, no study to date has compared the efficacy and safety of albuterol compared to levalbuterol in hyperkalemic patients with the properly adjusted dosing. So, in clinical practice, the investigators wanted to know based on evidence if levalbuterol can be an effective substitute for albuterol in lowering potassium levels in hyperkalemia patients while yielding fewer cardiac side effects. To answer this question, the investigators designed a single-centered controlled clinical trial that includes adult hyperkalemia patients in Aleppo University Hospital.

Start Date04 Nov 2021

Sponsor / Collaborator

University of Aleppo

NCT03952286

/ CompletedPhase 4IIT

ED-Initiated School-based Asthma Medication Supervision

Asthma is a common chronic condition that causes substantial morbidity among children and much of it is attributable to medication non-adherence. The National Asthma Education and Prevention Program (NAEPP) and the American Academy of Asthma, Allergy, and Immunology have urged others to develop more effective adherence programs.Schools are a logical setting to deploy such interventions because they are where children congregate, spend much of their day, and are frequently monitored. Because many schools serve a high proportion of minority and low-income students, engaging them presents a unique opportunity to reach populations who experience the greatest burden of preventable morbidity.
Supervising inhaled corticosteroid (ICS) use in the school setting can increase medication adherence and reduce episodes of poor asthma control. Under certain conditions, it can also be cost-effective. However, recruiting children from school settings tends to enroll children with mild asthma and infrequent health care use. Therefore, initiating supervised treatment in these children tends to burden school personnel with unnecessary work and diminishes the program's cost-effectiveness. To address this inefficiency, the investigators propose to recruit children who are discharged from the Hospital Emergency Departments (EDs) following successful treatment of an asthma attack. Such children have much higher risk of a future asthma attack than their peers.
The Pediatric Emergency Care Applied Research Network (PECARN) com- prises10 hospital-affiliated EDs that serve 1 million acutely ill and injured children annually. Their primary research mission is to reduce childhood morbidity and mortality by establishing creative partnerships between emergency medical service providers and their surrounding communities. The networks size and geographic diversity make it uniquely situated to develop, implement, and evaluate the feasibility and effectiveness of ED-Initiated School-Based Asthma Medication Supervision (ED-SAMS).
Approximately one-third of children treated for an asthma attack within PECARN experience a second ED-managed attack within 6 months. While the NAEPP guidelines recommend that long-term ICS treatment should be initiated at ED discharge, <20% of children actually receive a prescription for controller therapy. Observational data indicate that patients who use ICS following discharge are almost half as likely as non-users to experience a repeat ED visit. Many have also argued that ED-initiated treatment could be cost-effective. However, simply providing patients with a prescription does not ensure that they will actually use it once discharged. To ensure better medication adherence, the investigators propose to dispense ICS at discharge and supervise its use in the school setting.

Start Date01 Aug 2019

Sponsor / Collaborator

University of Arizona

NCT02802111

/ CompletedNot ApplicableIIT

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

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. The investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR) following administration of albuterol and

Start Date01 Jun 2015

Sponsor / Collaborator

Children's Hospital Los Angeles

100 Clinical Results associated with Levalbuterol hydrochloride

100 Translational Medicine associated with Levalbuterol hydrochloride

100 Patents (Medical) associated with Levalbuterol hydrochloride

405

Literatures (Medical) associated with Levalbuterol hydrochloride

01 Jun 2025·Drug Testing and Analysis

Beta₂‐adrenergic agonist salbutamol exhibits enantioselective disposition in skeletal muscle of lean young men following oral administration

Article

Author: Hostrup, Morten ; Narkowicz, Christian K. ; Jacobson, Glenn A. ; Nichols, David S. ; Eibye, Kasper ; Jessen, Søren

Abstract:

Salbutamol is a common short‐acting beta2‐adrenergic agonist used in treatment of asthma and exercise‐induced bronchoconstriction but also possesses anabolic and metabolic actions in skeletal muscle. As a chiral compound, salbutamol is a racemic 1:1 mixture of two enantiomers, (R)‐salbutamol and (S)‐salbutamol, which exhibit divergent pharmacokinetic and pharmacodynamic actions. Despite salbutamol being available for decades, information on the enantioselective disposition of salbutamol enantiomers in human skeletal muscle is absent. In this study, we determined concentrations of (R)‐salbutamol and (S)‐salbutamol by UHPLC–MS/MS in arterial plasma and vastus lateralis muscle samples from 12 lean young men 2½ and 7 h following ingestion of 24 mg oral salbutamol. Mean (range) arterial plasma concentrations were 10‐fold higher (p < 0.001) for (S)‐salbutamol than (R)‐salbutamol, being 33(9–62) and 49(30–84) ng·mL−1 for (S)‐salbutamol and 4 (1‐6) and 4 (2‐5) ng·mL−1 for (R)‐salbutamol 2½ and 7 h following administration, respectively, reflecting faster elimination of the (R)‐enantiomer. Mean (range) muscle concentrations were higher (p < 0.001) for (S)‐salbutamol than (R)‐salbutamol 2½ h (0.17 [0.1–0.26] vs. 0.04 [0.02–0.06]) and 7 h (0.31 [0.21–0.46] vs. 0.06 [0.04–0.12] ng·mgd.w.−1) after administration. However, muscle:plasma partition coefficient was two‐fold higher (p < 0.001) for (R)‐salbutamol than (S)‐salbutamol 7 h following administration. These observations demonstrate that oral salbutamol exhibits enantioselective disposition in systemic circulation and muscle favoring the (S)‐enantiomer but with higher relative partitioning of the (R)‐enantiomer in skeletal muscle. Furthermore, the concentration‐time profiles of salbutamol enantiomers are different in skeletal muscle and systemic circulation following oral ingestion. These findings have implications for the application of chiral switch (R)‐salbutamol in doping control.

01 May 2025·ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY

Exacerbation burden in patients treated as intermittent or mild-persistent asthma using short-acting β2-agonist rescue

Article

Author: Gandhi, Hitesh N ; Tkacz, Joseph P ; Lugogo, Njira L ; Lanz, Miguel J ; Gilbert, Ileen A

BACKGROUND:

Most people in the United States with asthma use therapies for intermittent/mild-persistent disease; however, exacerbations and death occur in patients with infrequent symptoms or labeled as mild asthma.

OBJECTIVE:

To evaluate relationships between short-acting β₂-agonist (SABA) use, exacerbations, and maintenance adherence in intermittent/mild-persistent asthma.

METHODS:

Retrospective cohort study using US Merative MarketScan administrative claims (January 2010 to December 2017) for patients aged 12 years or older treated as intermittent/mild-persistent asthma. Patients were indexed on a random SABA claim, with 12 months continuous enrollment pre- and post-index. Post-index SABA groups were defined as low (index fill only), medium (2-3 fills), and high (≥4 fills). Severe exacerbations were compared within the treatment, SABA fill, and adherence (medication possession ratio) groups through unadjusted comparison of proportions, χ², and odds ratios (OR [95% CI]); P less than or equal to .05.

RESULTS:

A total of 533,679 patients were included: 68.1% female; mean age (SD) 34.6 (18.3) years; 70.0% intermittent (SABA only) and 30.0% mild-persistent (8.6% low-dose inhaled corticosteroid [ICS]; 21.4% leukotriene modifier [LM]). The proportion of patients with high SABA fills differed among the treatments: SABA only (14.8%), low-dose ICS (37.0%), and LM (25.5%) (P < .001). The proportion experiencing 1 or more exacerbations was higher in SABA only (61.2%) vs low-dose ICS (40.4%) or LM (50.4%): OR (95% CI) 2.32 (2.28-2.37) and 1.55 (1.53-1.57), respectively (both P < .001). The medication possession ratio was less than 50% in 59.3% of patients with mild-persistent asthma; however, adherence was only related to exacerbations in the high SABA group.

CONCLUSION:

Patients treated as intermittent/mild-persistent asthma rely on SABA and experience exacerbations. Shifting from SABA only to an anti-inflammatory rescue therapy could decrease morbidity.

01 Nov 2024·Journal of Cystic Fibrosis

Development and preliminary validation of the personalized cystic fibrosis medication questionnaire (PCF-MQ)

Article

Author: Sawicki, Gregory S ; Riekert, Kristin A ; Daines, Cori L ; Phan, Hanna ; Frederick, Carla ; Oates, Gabriela ; McWilliams, Emma ; Psoter, Kevin J ; Woo, Ti ; Goodman, Andrea ; Milla, Carlos

BACKGROUND:

A personalized approach to assessing medication knowledge may identify opportunities for education to support self-management of cystic fibrosis (CF). This project describes the development, scoring, and preliminary validity of the Personalized CF Medication Questionnaire (PCF-MQ), designed to assess knowledge of prescribed CF medication purpose, administration, and dose and frequency.

METHODS:

Participants completed the PCF-MQ, the Knowledge of Disease Management (KDM-CF), and the Cystic Fibrosis-Medication Beliefs Questionnaire (CF-MBQ). Prescribed regimens were abstracted from medical records. Eligibility criteria were age 12 years and older, diagnosed with CF, and prescribed a CF medication. Statistical analyses were conducted using R software. Spearman rho was used to test correlations between measures.

RESULTS:

Sixty people with CF (pwCF) were enrolled; three people reported a regimen that substantially deviated from the medical record and were excluded from the analyses. The mean (SD) age was 20.2 (7.3) years, 54 % were female, and 74 % had a FEV1pp ≥70 %. The mean (SD) PCF-MQ total score was 77.8 (12.3) and knowledge scores ranged from a low of 58.3 for levalbuterol to 100 for ivacaftor. The PCF-MQ total score correlated with the KDM total score and subscales (Spearman Rho= 0.32-0.59, p < 0.05) and was not correlated with the CF-MBQ subscales (p > 0.05)).

CONCLUSIONS:

The PCF-MQ was correlated with another measure of general CF knowledge, but not health beliefs; because of the small sample size, this should be considered preliminary evidence of its validity. Advantages over existing CF knowledge measures include its practicality for use to help assess pwCF's knowledge about their prescribed regimen.

News (Medical) associated with Levalbuterol hydrochloride

09 Sep 2022

·endpts.com

Brand name inhalers are very good at blocking competition, better even than nebulizers, study finds

While just three brand-name inhalers approved between 1986 and 2020 now face generic competition (thanks in a large part to patent thickets and companies shifting old active ingredients to new devices), the same sort of long monopoly extensions are not as prevalent for nebulizers, a new study published today in Nature Biotechnology explains. The Harvard and University of Calgary authors note that nearly one-third of brand-name nebulizer solutions, which include drugs for asthma or other conditions in an aerosol mist form, faced generic competition before expiration of FDA-listed patents, compared to just 2% of brand-name inhalers. What’s more is that when considering actual market exclusivity (i.e., “the time from brand-name drug approval to generic competition, brand-name drug discontinuation, or 31 December 2020, whichever occurred first”), 13 brand-name solutions for nebulization had a median of just 5.2 years (IQR: 3.5–10.4 years) without generic competition. In contrast, inhalers saw 17.4 years of median protection when counting hops to new devices as a single product line (IQR: 13.2–23.2 years). Brand-name inhalers making such shifts to new devices, they wrote, as to a means to obtaining a longer period of exclusivity include Merck’s Proventil and Foradil, GSK’s Ventolin, Boehringer Ingelheim’s Combivent and Atrovent, and AstraZeneca’s Pulmicort. So why the wide discrepancy between inhalers and nebulizers? First author William Feldman of Harvard Medical School told Endpoints News via email: But nebulizers also saw shorter periods of market exclusivity because of delays in the release of brand-name nebulizer solutions, Feldman , Doni Bloomfield, Reed Beall and Aaron Kesselheim wrote. “The time between the release of inhalers and the release of the same ingredients in nebulized form has meant that certain at-risk patients lacked access to preferred forms of treatment,” they wrote. “Physicians frequently rely on nebulizers to treat asthma and COPD, because some patients may not be able to use inhalers and because some simply favor nebulizers. A recent study of Black and Latino/Latina patients with moderate-to-severe asthma, for example, found that 67% chose to use nebulizers for SABA administration.” Another concerning finding cited by the authors is a recent turn by brand name manufacturers to enantiomers of older racemic formulations — levalbuterol (an enantiomer of racemic albuterol) and arformoterol (an enantiomer of racemic formoterol) — “despite little, if any, clinical benefit associated with the newer products compared to the older ones,” they added. So how to fix this situation? The authors point to regulatory reforms, saying it’s:

17 May 2022

·www.biospace.com

Exciting Advancements in Multiple Myeloma, Asthma and Alzheimer’s

In recent months, the biotech and biopharma industries have been struggling with layoffs and dropping stocks. However, some companies are still experiencing success. Sanofi, AstraZeneca, Avillion and Diadem have recently announced positive clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease. Sanofi's Sarclisa Scores in Multipe Myeloma Sanofi’s drug isatuximab, marketed under the brand name Sarclisa, showed positive results in a Stage III clinical trial. Sarclisa is a drug that, when used in combination with carfilzomib and dexamethasone, can treat patients suffering from relapsed multiple myeloma. Sarclisa is a monoclonal antibody that targets the CD38 receptor on multiple myeloma cells. In the Phase III Ikema clinical trial, Sarclisa and its combination drugs improved patients’ median progression-free survival rate. When patients were treated with only dexamethasone, the median progression-free survival time was only 19.2 months. However, with Sarclisa and carfilzomib, the survival time went up to 35.7 months. The combination of Sarclisa, carfilzomib and dexamethasone created a median progression-free survival time of 41.7 months. AstraZeneca and Avillion AstraZeneca’s drug PT027 is a novel inhaled corticosteroid, and a fixed-dose combination of albuterol and budesonide, PT027, is designed to help patients with asthma. AstraZeneca is working with Avillion LLP, a drug development company, to help move the drug through regulatory approvals. Avillion announced that PT027 showed positive results in its Phase III Mandala clinical trial. The data showed that PT027 reduces the risk of severe asthma attack exacerbation by 27% compared to albuterol alone. Patients also experienced an improvement in symptom control while using PT027. The data is published in the New England Journal of Medicine, and it will be presented at the American Thoracic Society (ATS) 2022 International Conference. Following the good news, Avillion said that it plans on filing a new drug application (NDA) with the FDA, as well as a new clinical trial. “We have enjoyed an excellent collaboration with AstraZeneca, under which we have delivered these large and complex trials during a pandemic and have ongoing regulatory responsibility for the NDA filing,” said Allison Jeynes, MD, CEO at Avillion. “Furthermore, this partnership has recently expanded to include a new decentralized, randomised trial in patients with mild asthma, which is anticipated to kick off in the coming months." Diadem Italy-based Diadem SpA shared exciting news about its AlzoSure Predict product, a blood test for Alzheimer’s disease. The blood test measures a patient’s levels of p53 protein, a protein associated with Alzheimer’s disease. By measuring the protein, AlzoSure can determine whether an individual has Alzheimer’s disease, as well as accurately predict whether patients who currently have no or very mild cognitive impairments will suffer from full-blown Alzheimer’s disease within the next six years. The product was tested in a retrospective longitudinal study with 482 individuals aged 60 or older. The data from the study showed that AlzoSure’s blood biomarker test was more accurate than the Aβ-PET imaging scans, which are currently the main method used for diagnosing patients with Alzheimer’s disease and giving them a prognosis for how quickly the disease will progress. The results from the clinical study on AlzoSure are being published in the Journal of Prevention of Alzheimer's Disease. The article is titled, "A Conformational Variant of p53 (U-p53AZ) as Blood-Based Biomarker for the Prediction of the Onset of Symptomatic Alzheimer's Disease.” AlzoSure recently received an FDA Breakthrough Device Designation and an CE-IVD marking for the EU.

Clinical ResultCollaborateAntibody

100 Deals associated with Levalbuterol hydrochloride

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R&D Status

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Indication	Country/Location	Organization	Date
Airway Obstruction	China	Joincare Pharmaceutical Group Industry Co., Ltd.	26 Sep 2019
Bronchial Spasm	United States	Hikma Pharmaceuticals USA, Inc.	25 Mar 1999

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03952286 (EDSAMS, CTgov)	Phase 4	Childhood asthma	13	budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home and School Supervision)	vzmtdpwkag = khdiomuxbh rtcwwtirlo (yfpisbgbzj, tnujlejpgz - uilcijfkvj) View more	-	19 Nov 2025
				budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home Supervision)	vzmtdpwkag = nhxuccdxep rtcwwtirlo (yfpisbgbzj, fwduzsrtjw - trgbydilkd) View more
NCT02802111 (CTgov)	Not Applicable	Hypoxia	24	Albuterol (Albuterol 5 mg First, Then Levalbuterol 2.5 mg)	ubffnkdupr(wgjdvynzyw) = zvdupuffsi zjabxuyhvf (oadpgzgnwu, mazniyvmvs - scjusvjvxf) View more	-	28 Oct 2020
				Levalbuterol (Levalbuterol 2.5 mg First, Then Albuterol 5 mg)	ubffnkdupr(wgjdvynzyw) = qonrjhjnmu zjabxuyhvf (oadpgzgnwu, fzobwhdbgz - qatqrklinm) View more
NCT01833026 (CTgov)	Not Applicable	Pulmonary Disease, Chronic Obstructive	56	Spirometry test+Levalbuterol (COPD Assessment and Management Recommendations)	onkwdryzlh = omqniebpyd wjkvyykkyy (wipfmaougy, okmueemsxn - itxjeodejg) View more	-	24 Dec 2019
				Spirometry test+Levalbuterol (Usual Care)	onkwdryzlh = ezzxeetkvj wjkvyykkyy (wipfmaougy, dujftgutty - dhskcmshot) View more
NCT01151579 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive \| Arrhythmias, Cardiac \| Sepsis ... View more	89	Levalbuterol+Albuterol	xzkjxmbgzn(hdcquvhxjr) = gtfgirabob gnsvajgagv (mqcyyvmnug, 5.4) View more	-	23 Oct 2015
NCT00585039 (Xopenex, CTgov)	Phase 4	Acute asthma	101	Levalbuterol (Xopenex) (Levalbuterol (Xopenex))	vmtnekqtqp(sztrkdqppq) = rvnylvnxxo zrxaxyujkl (zbduigcvyo, ytegicecjr - gcgbdochsv) View more	-	16 Aug 2011
				Albuterol (Albuterol)	vmtnekqtqp(sztrkdqppq) = fqolzuahch zrxaxyujkl (zbduigcvyo, prngcvvtqq - nvpamlhxst) View more

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