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

NCT01833026 / CompletedNot ApplicableIIT

Comparative Effectiveness of COPD Assessment and Management Bundle Versus Usual Care in Patients Suspected of Having COPD

Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease that makes it harder to breathe over time. To date, there is no cure for COPD, but it can be managed when diagnosed and proper medical care is provided.
The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient outcomes (the condition of a patient's health) compared to usual care which may or may not include the use of spirometry. Spirometry is a standardized test used in medical practice that measures how much air your lungs can hold and how forcefully you can breathe out.
For this study, the investigators will compare two groups: 1) intervention (treatment) group and 2) usual care group (control). The intervention group will have a spirometry test and the results will be provided to the primary care physician. The usual care group will not initially have a spirometry test. Both groups will be followed for outcomes.

Start Date01 Mar 2013

Sponsor / Collaborator

University of Illinois

[+1]

100 Clinical Results associated with Levalbuterol hydrochloride

100 Translational Medicine associated with Levalbuterol hydrochloride

100 Patents (Medical) associated with Levalbuterol hydrochloride

Literatures (Medical) associated with Levalbuterol hydrochloride

01 Apr 2008·The Journal of the American Osteopathic Association

Paradoxical response to levalbuterol.

Article

Author: Dennis E Amundson ; Sarah E Broski

Asthma is a common condition that can substantially affect patients' quality of life. Although several drugs, most commonly beta-adrenergic agonists, alleviate symptoms of asthma, they may cause paradoxical bronchospasm or paradoxical bronchoconstriction. Levalbuterol hydrochloride-a pure form of the (R)-stereoisomer in racemic albuterol-eliminates the adrenergic properties that can cause such adverse effects. However, we report a case of paradoxical bronchoconstriction in a 36-year-old man who was recently diagnosed as having new-onset asthma and was treated with levalbuterol.

01 Jul 2004·The Journal of the American Osteopathic Association

Levalbuterol in the treatment of patients with asthma and chronic obstructive lung disease.

Review

Author: Gilbert E. D'Alonzo

Effective asthma control requires long-term (anti-inflammatory) controller medications for patients with mild-persistent to severe-persistent disease, and quick-relief bronchodilator medication for all patients with asthma to control intermittent symptoms of cough, wheeze, and bronchoconstriction, as well as acute exacerbations. For patients with chronic obstructive pulmonary disease, quick-relief and long-acting bronchodilators are primarily used in the maintenance and treatment of associated symptoms, including shortness of breath. For many years, the most widely used bronchodilator has been racemic (R, S)-albuterol, a short-acting beta2-adrenergic agonist, commonly dispensed as an inhaled aerosol or solution. Until the introduction of levalbuterol inhalation solution (Xopenex) in 1999, all marketed forms of albuterol (including Ventolin and Proventil brands) were racemic mixtures composed of a 1:1 ratio of (R)- and (S)-stereoisomers. Administered as a proportionally equivalent nebulized dose, levalbuterol [(R)-albuterol] provides greater bronchodilation than racemic albuterol and, in the appropriate clinical setting, offers the possibility for improving clinical outcomes in patients with asthma and other obstructive airway diseases. Additionally, levalbuterol can be given at lower doses than racemic albuterol to provide comparable bronchodilation, with the potential for reduced beta-mediated adverse effects in adults and children. Only since the past decade has the technology to separate stereoisomers become available, and thus the biologic activities of the albuterol stereoisomers had not been established. Binding studies have demonstrated that (R)-albuterol binds to the beta2-adrenergic receptor with a high affinity, whereas (S)-albuterol binds with 100-fold less affinity than (R)-albuterol. Other evaluations have suggested that (R)-albuterol possesses the bronchodilatory, bronchoprotective, and ciliary-stimulatory properties of racemic albuterol, while (S)-albuterol does not contribute beneficially to the therapeutic effects of the racemate and was originally assumed to be inert. However, preclinical evaluations have shown that (S)-albuterol has effects that work in opposition to (R)-albuterol and may diminish the therapeutic effects of (R)-albuterol.

01 Jun 2004·The Annals of pharmacotherapyQ4 · MEDICINE

Compatibility of Budesonide Inhalation Suspension with Four Nebulizing Solutions

Q4 · MEDICINE

Article

Author: Cruz-Rivera, Mario ; McKenzie, Jane E

BACKGROUND::

Nebulizable medications often are mixed to simplify asthma medication regimens.

OBJECTIVE::

To establish the in vitro chemical compatibility and stability of budesonide inhalation suspension 0.25 mg/2 mL and 0.5 mg/2 mL mixed in Pari LC Plus jet nebulizer cups with 3 mL of levalbuterol hydrochloride 0.63 mg/3 mL and 1.25 mg/3 mL; 0.5 mL of albuterol sulfate 5 mg/mL; 2 mL of cromolyn sodium 20 mg/2 mL; or 2.5 mL of ipratropium bromide 0.2 mg/mL.

METHODS::

We developed and validated isocratic HPLC methods to permit separation of the admixture components from aliquots taken 0, 5, 15, and 30 minutes after mixing. Admixtures were prepared and analyzed at room temperature. Each assay was conducted 3 times using separate nebulizer cups. All components were quantified by external standards using HPLC-derived peak area. Appearance and pH of the admixtures were recorded.

RESULTS::

No additional peaks occurred in any HPLC chromatogram for any medication from any admixture. With the exception of ipratropium bromide at 93%, each admixture retained >97% of the initial concentration of each medication in the nebulizer cup. There was no significant change in pH or visual identification of a precipitate in any admixture of active drugs.

CONCLUSIONS::

These data support the chemical compatibility of budesonide inhalation suspension for up to 30 minutes with other commonly used nebulized medications for controlling pediatric asthma symptoms.

News (Medical) associated with Levalbuterol hydrochloride

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

External Link

KEGG	Wiki	ATC	Drug Bank
-	Levalbuterol hydrochloride	R03CC	DBSALT001453

R&D Status

10 top approved records.

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02802111 (CTgov)	Not Applicable	-	24	Albuterol (Albuterol 5 mg First, Then Levalbuterol 2.5 mg)	alnnliacxn(jaszcejslf) = cuxbnnwehd mwjwvsksio (proxvtcaiy, dycartefrb - oeotounlfv) View more	-	28 Oct 2020
				Levalbuterol (Levalbuterol 2.5 mg First, Then Albuterol 5 mg)	alnnliacxn(jaszcejslf) = cjofmdsmne mwjwvsksio (proxvtcaiy, ihihivyswo - abhaqilcdb) View more
NCT00585039 (Xopenex, CTgov)	Phase 4	Acute asthma	101	Levalbuterol (Xopenex) (Levalbuterol (Xopenex))	vmrnlhinre(ioyftbinbz) = olqomveeuz gdzmalutvf (msmcttxkia, uzlbkuundi - hfeeceruyw) View more	-	16 Aug 2011
				Albuterol (Albuterol)	vmrnlhinre(ioyftbinbz) = knmvpuriji gdzmalutvf (msmcttxkia, mehhlvabtm - juyvqbekyi) View more

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