ANCHOR is a prospective, multi-center, phase IV, interventional, single-arm, open-label study of 2,000 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy.

Start Date10 May 2024

Sponsor / Collaborator

AstraZeneca PLC

[+1]

CTR20240652

/ CompletedNot Applicable

酒石酸左沙丁胺醇吸入气雾剂在中国健康受试者空腹状态下的单中心、随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of levosalbutamol tartrate inhalation aerosol in Chinese healthy subjects under fasting condition

主要研究目的：研究健康受试者空腹经口吸入受试制剂酒石酸左沙丁胺醇吸入气雾剂（0.045 mg/INH*2次）和参比制剂“Xopenex Hfa®”（0.045 mg/INH*2次）的药代动力学，评价空腹经口吸入酒石酸左沙丁胺醇吸入气雾剂的生物等效性。次要研究目的：研究受试制剂酒石酸左沙丁胺醇吸入气雾剂和参比制剂“Xopenex Hfa®”在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation salbutamol tartrate inhalation aerosol (0.045 mg/INH*2 times) and the reference preparation "Xopenex Hfa®" (0.045 mg/INH*2 times) in healthy subjects after oral inhalation on an empty stomach, and to evaluate the bioequivalence of the salbutamol tartrate inhalation aerosol after oral inhalation on an empty stomach. The secondary purpose of the study is to study the safety of the test preparation salbutamol tartrate inhalation aerosol and the reference preparation "Xopenex Hfa®" in healthy subjects.

Start Date26 Feb 2024

Sponsor / Collaborator

Yangzhou Sanyao Pharmaceutical Co. Ltd.

NCT05366764

/ CompletedPhase 1

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SAR443765 in Healthy Adult Participants and of a Single Dose of SAR443765 in Participants With Mild-to-moderate Asthma

This is a 3-part, parallel group treatment, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics after sequential single and multiple ascending doses of SAR443765 in healthy adult participants, and after a single dose of SAR443765 in participants with mild-to-moderate asthma.

Start Date08 Jun 2022

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Levalbuterol Tartrate

100 Translational Medicine associated with Levalbuterol Tartrate

100 Patents (Medical) associated with Levalbuterol Tartrate

195

Literatures (Medical) associated with Levalbuterol Tartrate

01 Nov 2024·Journal of Cystic Fibrosis

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

Article

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

BACKGROUNDA 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.METHODSParticipants 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.RESULTSSixty 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)).CONCLUSIONSThe 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.

19 May 2024·Cureus

Estimating the Economic Impact of Levalbuterol’s Potential Transition From the National Reimbursement Drug List for the Treatment of Pediatric Asthma in China: A Budget Impact Analysis

Article

Author: Tang, Tingke ; Lin, Chunlong ; Wu, Yingyu ; Zhi, Canghong ; Li, Xuan

Background Levalbuterol is a short-acting β₂-agonist (SABA) indicated for treating or preventing asthma exacerbation. It was included in the 2020 Chinese National Reimbursement Drug List (NRDL). This study estimates the economic impact of levalbuterol's status change within and withdrawal from the NRDL in treating pediatric asthma from a publicly funded medical insurance perspective. Methodology A prevalence-based budget impact model was developed. The analysis compared a world with a levalbuterol scenario to a world without levalbuterol. Epidemiological data were obtained from the existing literature. Cost data were estimated based on the drug dosage in clinical trials, real-world settings, and expert opinions. Scenario analysis considered the same length of stay (LOS) in the two groups. One-way sensitivity analyses were carried out to show the impact of varying individual parameters. Results In the base-case analysis, compared to the world without scenario, the preservation of levalbuterol resulted in cost savings of ¥82.8 million in China over three years. In the scenario analysis, savings decreased to ¥76.1 million over three years. Sensitivity analysis showed that, for the most part, the results were robust to changes in input parameter values. Conclusions Using levalbuterol may lead to substantial cost savings for Chinese society.

26 Apr 2024·Cureus

Quantifying the Length of Stay and Economic Impact of Albuterol and Levalbuterol in Hospitalized Patients With Chronic Obstructive Pulmonary Disease: A Retrospective Cohort Study

Article

Author: Zhang, Hongmei ; Liu, Xun ; Li, Xuan ; Yang, Zaixing ; Zeng, Liang ; Ran, Yalan ; Wang, Li ; Qiu, Yao ; Lu, Junyu ; Zhi, Canghong

Introduction Chronic obstructive pulmonary disease (COPD) affects millions in China and imposes a considerable economic burden on hospitalized patients who experience exacerbations. Nebulized short-acting beta-2 agonists (SABA) are recommended as initial therapy for exacerbation patients, but the optimal SABA remains uncertain. This study aimed to evaluate the impact of different SABAs, such as albuterol and levalbuterol, on the length of stay (LOS) and direct medical costs among hospitalized patients diagnosed with COPD. Methods This retrospective cohort study uses linked hospital administrative data from three hospitals in Chongqing. Patients with COPD, aged 40 years and older, who had been continuously treated with nebulized albuterol or levalbuterol during hospitalization, were eligible for the study. Patients were matched 1:1 by sex, age, and severity according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades 1-4. Patients were grouped according to the different SABA treatments they received. Demographic, economic, and clinical data were retrieved. LOS and direct healthcare costs were assessed. Results A total of 158 COPD patients were included, with 79 in each treatment group. Patients treated with levalbuterol had a significantly shorter median LOS (7.0 days vs. 8.0 days, P=0.003) and fewer direct healthcare median costs (total cost: ¥8,868.3 vs. ¥10,290.7, P=0.014; COPD-related western medicine fees: ¥383.8 vs. ¥505.3). Patients aged 60 or older were more likely to experience longer LOS and higher direct costs. Conclusion This retrospective cohort analysis supports that albuterol was associated with longer LOS and higher costs than levalbuterol.

News (Medical) associated with Levalbuterol Tartrate

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:

02 Aug 2022

·www.globenewswire.com

C4 Therapeutics Appoints Experienced Clinical Development Leaders Laura Bessen, M.D. and Donna Grogan, M.D. to Board of Directors

– Dr. Laura Bessen Brings More Than Two Decades of Experience Across Medical Affairs and Clinical Development in Support of Successful Product Launches – – Dr. Donna Grogan Joins as Accomplished Drug Development and Regulatory Strategy Leader With More than 25 Years of Experience in Developing Novel Therapeutics – – Appointments Highlight C4T’s Continued Commitment to Evolving Board Composition – WATERTOWN, Mass., Aug. 02, 2022 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced the appointments of Laura Bessen, M.D. and Donna Grogan, M.D. to its board of directors. “We are delighted to announce Laura and Donna as C4T’s newest directors after an extensive search that included a talented and diverse pool of clinical development leaders experienced in helping companies bring innovative therapies to patients,” said Bruce Downey, chairman of C4 Therapeutics. “On behalf of the board of directors, I look forward to working closely with Laura and Donna as C4T continues to evolve in our pursuit of delivering on the potential of targeted protein degradation science to create a new generation of medicines and change how diseases are treated.” “I am eager to use my broad experiences in medical affairs and clinical development to help C4T advance multiple oncology programs to benefit patients,” said Laura Bessen, M.D. “C4T is at a transformational stage, with two programs in the clinic and additional programs preparing to advance into clinical trials. I am excited to help C4T capitalize upon opportunities ahead.” Commenting on joining the C4T board of directors, Donna Grogan, M.D. said, “It is an exciting time to join C4T and partner with the company to navigate drug development and regulatory milestones to advance an innovative portfolio of small-molecule medicines. I look forward to working with my C4T colleagues to help the Company apply its industry-leading targeted protein degradation science to transform how patients are treated.” About Laura Bessen, M.D.Laura Bessen, M.D. currently serves as managing partner at Maxsam Advisors LLC where she provides strategic clinical and medical affairs advice to clients across the biotechnology and pharmaceutical industries. Previously, she held roles of increasing responsibility over a 15-year career at Bristol Myers Squibb (BMS), most recently as Vice President, Head of US Medical. During her tenure at BMS, she helped launch 11 new products including Opdivo®, Yervoy®, elotuzomab, and Eliquis® and co-led BMS’ partnership with Gilead to develop Atripla®. Dr. Bessen also co-led the development of BMS product commercialization model, life cycle management and launch investment principles. Earlier in her career, Dr. Bessen served in medical affairs roles at DuPont Pharmaceuticals. She currently serves on the Board of Directors of Artiva Biotherapeutics, an oncology company developing and advancing off-the-shelf, allogeneic natural killer cell therapies for patients with hematologic cancers or solid tumors. Dr. Bessen received her M.D. degree from New York University School of Medicine and B.S. in biochemistry from the State University of New York at Binghamton. About Donna Grogan, M.D.Donna Grogan, M.D. currently serves as Principal of Grogan Consulting LLC where she supports clients across drug development, regulatory strategy, trial design and data interpretation. Between September 2013 and June 2019, Dr. Grogan served as Chief Medical Officer of Clementia Pharmaceuticals, which was acquired by Ipsen in April 2019. She previously served as Chief Medical Officer for several HealthCare Ventures portfolio companies including Anexon, Apofore, and DecImmune. Between February 2007 and August 2011, Dr. Grogan served as Chief Medical Officer, Senior Vice President Clinical Development at FoldRx Pharmaceuticals, which was acquired by Pfizer in October 2010. Earlier in her career, she held roles of increasing responsibility at Sepracor, Inc. where she was involved in multiple high-profile product approvals including Lunesta®, Xopenex HFA®, and Brovana™. Dr. Grogan previously served as a board member, including membership on the Compensation Committee and the Scientific Committee, of Momenta Pharmaceuticals until it was acquired by J&J in October 2020. She holds a M.D. from University of Illinois College of Medicine and a B.A. from College of the Holy Cross. About C4 TherapeuticsC4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transform patients’ lives. C4T is leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines that harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. C4T is advancing multiple targeted oncology programs to the clinic and expanding its research platform to deliver the next wave of medicines for difficult-to-treat diseases. For more information, please visit www.c4therapeutics.com. Forward-Looking StatementsThis press release contains “forward-looking statements” of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our TORPEDO® platform in the development of novel, selective, orally bioavailable degraders; the potential timing, design and advancement of our pre-clinical studies and clinical trials, including the potential timing for regulatory authorization related to clinical trials and other clinical development activities; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our pre-clinical studies or clinical trials in any future studies or trials; and regulatory developments in the United States and foreign countries. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing, advancement and conduct of pre-clinical and clinical studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will cost more to develop or may not be successfully developed and commercialized; and the risk that the results of pre-clinical studies and/or clinical trials will or will not be predictive of results in connection with future studies or trials. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in C4 Therapeutics’ most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4 Therapeutics undertakes no duty to update this information unless required by law. Investor Contact: Kendra Adams SVP, Communications & Investor Relations Kendra.Adams@c4therapeutics.com Media Contact: Loraine Spreen Director, Corporate Communications & Patient Advocacy LSpreen@c4therapeutics.com Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/99a1b2ca-915c-446c-95e3-28fb99720bcb https://www.globenewswire.com/NewsRoom/AttachmentNg/4480470b-bbb5-4eb9-bc72-241940f28d18

Cell TherapyCollaborate

100 Deals associated with Levalbuterol Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
D04703	Levalbuterol Tartrate	R03AC02	DB13139

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bronchial Spasm	US	Lupin, Inc.	11 Mar 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
airway disease	Preclinical	US	Sumitomo Pharma America, Inc.	01 Jul 2014
Allergic asthma	Discovery	-	Sumitomo Pharma America, Inc.	01 Apr 2006
Asthma	Discovery	CA	Sumitomo Pharma America, Inc.	01 Jan 2003
Asthma, Exercise-Induced	Discovery	US	Sumitomo Pharma America, Inc.	01 Oct 2002
Pulmonary Disease, Chronic Obstructive	Discovery	US	Sumitomo Pharma America, Inc.	01 Feb 2002
Pulmonary Disease, Chronic Obstructive	Discovery	CA	Sumitomo Pharma America, Inc.	01 Feb 2002
Acute asthma	Discovery	US	Sumitomo Pharma America, Inc.	01 Nov 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02414854 (LIBERTY ASTHMA QUEST \| QUEST, CTgov)	Phase 3	Persistent asthma	1,902	Placebo+Levalbuterol+Albuterol/Salbutamol (Placebo (for Dupilumab 200 mg) q2w)	ddpfnhaadv(lpzppoxfyp) = dnfhwbvekd ibfgjwrkhh (bduvkwjkun, wnhnonwmuj - vxadnzrejr) View more	-	23 Oct 2018
				Inhaled corticosteroid (ICS) therapy+Dupilumab+Levalbuterol+Albuterol/Salbutamol (Dupilumab 200 mg q2w)	ddpfnhaadv(lpzppoxfyp) = sudscnawxq ibfgjwrkhh (bduvkwjkun, stqahxaily - lumtwxdxvv) View more
NCT02528214 (LIBERTY ASTHMA VENTURE \| VENTURE, CTgov)	Phase 3	Asthma	210	Placebo+Albuterol/Salbutamol+Oral corticosteroid therapy (prednisone/prednisolone)+Levalbuterol (Placebo q2w)	zlrtizmuvc(exkahjtiij) = jrmcirtouf qprhglumns (dlepprmncy, zljjsmlfqe - zezojbvduh) View more	-	23 Oct 2018
				Inhaled corticosteroid (ICS) therapy+Albuterol/Salbutamol+Dupilumab+Oral corticosteroid therapy (prednisone/prednisolone)+Levalbuterol (Dupilumab 300 mg q2w)	zlrtizmuvc(exkahjtiij) = rgrhnjlaqw qprhglumns (dlepprmncy, ugliyxskru - ubqnbyezxs) View more
NCT01312961 (CTgov)	Phase 2	Asthma \| Eosinophilic Asthma	104	Placebo (for Dupilumab)+Levalbuterol+Albuterol+Fluticasone monotherapy+Fluticasone/Salmeterol combination therapy (Placebo (for Dupilumab))	dhsawhwrrb(ieyikgevmv) = nevshlgqvf rjunsfzniu (zmspiuqnym, xscncbvvmj - ittuizeffr) View more	-	08 Jun 2017
				Dupilumab+Levalbuterol+Albuterol+Fluticasone monotherapy+Fluticasone/Salmeterol combination therapy (Dupilumab 300 mg qw)	dhsawhwrrb(ieyikgevmv) = gwvcfzpqro rjunsfzniu (zmspiuqnym, nswjwmupyq - ogxqhvqmno) View more
NCT02150499 (CTgov)	Phase 3	Asthma \| airway disease	18	placebo+levalbuterol tartrate HFA inhalation aerosol (Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA)	dbcuqqkdoq(gtsjxjgnzh) = eywuriimfg jevrxmiuoz (sfybonhmqd, kecyfipugf - xcbicskilx) View more	-	03 Feb 2016
				levalbuterol tartrate HFA inhalation aerosol (Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol)	dbcuqqkdoq(gtsjxjgnzh) = iyihhkmhdl jevrxmiuoz (sfybonhmqd, yvvnbvljjy - cwaihrowji) View more
NCT01151579 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive \| Arrhythmias, Cardiac \| Sepsis \| Shock	89	Levalbuterol+Albuterol	hbhpwpeyvc(plcedrewah) = jlrqjzgjgz igitcrvscp (bujhyygvpp, uanhvthcyl - qkgisvsbyp) View more	-	23 Oct 2015
NCT00809757 (CTgov)	Phase 3	Asthma	197	Placebo (Placebo)	tykjmpfgmu(ogrhfmdhae) = hqirzjczag ppaclfxuec (btnhswxwxo, yuqwaapybq - fypfapbfqh) View more	-	28 Jul 2014
				Levalbuterol (Levalbuterol MDI)	tykjmpfgmu(ogrhfmdhae) = yjxqdoxcgk ppaclfxuec (btnhswxwxo, yjwkwzdfml - vwzjvzpxij) View more
AAAAI2007	Not Applicable	IL-6	-	(R)-albuterol	enffzrziny(easuxxbftw) = talzmleofs jstmryinqc (ugvvmokorh )	-	01 Jan 2007
				(S)-albuterol	enffzrziny(easuxxbftw) = iqkjjsnfxg jstmryinqc (ugvvmokorh )
AAAAI2006	Not Applicable	-	-	Levalbuterol (1.25mg)	wucvichahv(degqsqdrrw) = nnqrhelokh qzxkzbnwfm (qcusagyzan )	-	01 Feb 2006
				Racemic Albuterol (2.5mg)	wucvichahv(degqsqdrrw) = lquhhaiodd qzxkzbnwfm (qcusagyzan )
AAAAI2005	Not Applicable	-	-	(R)-albuterol	mbuorbehbq(dvxmjyoxpd) = wqdfwbipfl gvgvktkafn (htxeafwxws )	-	19 Mar 2005
				(S)-albuterol	mbuorbehbq(dvxmjyoxpd) = uuphjdgrom gvgvktkafn (htxeafwxws )

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