Lonhala Magnair (glycopyrrolate) / Sumitomo Pharma, Pari - LARVOL DELTA

Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD. (PubMed, NPJ Prim Care Respir Med) - "These secondary analyses and real-world data complement the primary results with nebulized GLY from Phase III studies and support the need for the inclusion of patients representative of real-world clinical practice in RCTs. In addition, these data suggest that RCTs for COPD therapies should be complemented with real-world observational studies."

Clinical • Journal • Review • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Immunology • Mood Disorders • Psychiatry • Pulmonary Disease • Respiratory Diseases

Efficacy of Nebulized Glycopyrrolate on Lung Hyperinflation in Patients with COPD. (PubMed, Pulm Ther) - P4 | "This is the first study to evaluate the effect of nebulized GLY on lung deflation. Nebulized GLY resulted in marked improvements in RV up to 6 h post-treatment, compared with placebo. Improvements were also observed with GLY in spirometric and plethysmographic parameters of lung function."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

"Wonderful overview of managing ventricular arrhythmias in structural heart disease by #ConnorBarrett #EP101" (@narrowQRS)

Atrial Fibrillation • Cardiovascular • Heart Failure

"Day 2! #EP101 @BSCCardiology @narrowQRS #DrEstes" (@pcw_EP)

Cardiovascular

"Thank you for your interesting presentation. It is possible to receive all Presentations of EP 101 Programs in 2021 as Online Film on BSc Website or PDF receive?" (@vorhofflatter)

"Fabulous lecture as always by @Ed_Gerst on day #1 of #EP101 !!" (@narrowQRS)

"EP with a view 🤓 #EP101 w/ @narrowQRS #DrMarkEstes" (@alexandra_regia)

""How to read multi-channel EGM recordings." The basics of orientation make the biggest difference! Other important factors--channel color, grouping, and clipping @narrowQRS @BSCCardiology #EP101 #EPeeps" (@pcw_EP)

Cardiovascular

"“The forest and the trees.” Big and small telling the story of the heart. @Zo_EP2 @BSCCardiology @narrowQRS #EP101 #Epeeps" (@pcw_EP)

Cardiovascular

"Dr. Sam Asirvatham going to town on his virtual whiteboard, dropping some knowledge about SVT maneuvers! #EP101" (@narrowQRS)

An ultrasensitive LC-MS/MS method and application to clinical dose-range finding for glycopyrrolate via an e-Nebulizer. (PubMed, Bioanalysis) - "Pharmacokinetic analysis showed good dose proportionality over the studied dose range, where C was found to be Y = 1.354*X + 1.968 (r = 0.9984), and AUC was Y = 4.661*X + 23.32 (r = 0.9976). The study clearly demonstrated the importance of an ultrasensitive (500 fg/ml LLOQ) method."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Exacerbations in Patients with Chronic Obstructive Pulmonary Disease Treated with Nebulized Glycopyrrolate versus Other Long-Acting Muscarinic Antagonists: A U.S. Healthcare Administrative Database Analysis (ATS 2021) - "Compared to patients new to LAMA products, patients newly initiated GLY had a greater reduction in both moderate and severe exacerbations during 6-month after treatment initiation compared to 6-month prior. This retrospective analysis was limited by the small cohort size and short observation window."

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

"Please join Dr. Estes and myself for the annual EP101 "rite of passage" conference for incoming EP Fellows!!! #VirtualLearning #AmazingFaculty" (@narrowQRS)

Impact of Comorbidity Prevalence and Cardiovascular Disease Status on the Efficacy and Safety of Nebulized Glycopyrrolate in Patients with COPD. (PubMed, Int J Chron Obstruct Pulmon Dis) - "A simple comorbidity count demonstrated that a majority of patients with COPD in the GOLDEN 3 and 4 studies had multiple comorbidities, with CVD being common in those with high comorbidity count. Results from this post hoc analysis demonstrate that GLY improved FEV and SGRQ scores in individuals with COPD, independent of their comorbidities or CVD status."

Clinical • Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Hypertension • Immunology • Osteoarthritis • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology

Effect of SGRQ-Defined Chronic Bronchitis at Baseline on Treatment Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Significant improvements in EXACT-RS total scores were observed only in the CB group. Together, these results support the use of GLY 25 μg BID in patients with COPD, regardless of their CB status."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Improvement in Lung Function and Patient-Reported Outcomes in Patients with COPD with Comorbid Anxiety and Depression Receiving Nebulized Glycopyrrolate in the GOLDEN 3 and 4 Studies. (PubMed, Int J Chron Obstruct Pulmon Dis) - "GLY 25 µg BID resulted in numerical improvements in FEV, SGRQ total scores and SGRQ responder rates in patients with moderate-to-very-severe COPD, regardless of A/D status at baseline; significant improvements were noted only in the A/D (+) group. The results emphasize the importance of considering underlying comorbidities including A/D when evaluating the efficacy of COPD treatments."

Clinical • Journal • Patient reported outcomes • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Immunology • Mood Disorders • Psychiatry • Respiratory Diseases

Drugs for COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Infectious Disease • Tobacco Cessation

Comparison table: Inhaled long-acting bronchodilators for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease

[VIRTUAL] Impact of Cleaning and Supplemental Maintenance Instructions of the Magnair Vibrating Membrane Nebulizer on Device Nebulization Times (ATS-I 2020) - "These results highlight the consistency of Magnair nebulization and delivery of drug over continuous use with regular cleaning, irrespective of backwashing the aerosol head. When the recommended cleaning is performed as recommended, the Magnair device still delivers the drug within specifications for up to 60 days, and the supplemental backwash procedure is not necessary."

Clinical

GOLDEN-3-Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (clinicaltrials.gov) - P3; N=645; Active, not recruiting; Sponsor: Sunovion Respiratory Development Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation

A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD (clinicaltrials.gov) - P3; N=1050; Recruiting; Sponsor: Sunovion Respiratory Development Inc.

New P3 trial • Biosimilar • Immunology • Inflammation

Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4) (clinicaltrials.gov) - P3; N=645; Recruiting; Sponsor: Sunovion Respiratory Development Inc.; Not yet recruiting -> Recruiting

Enrollment open • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation

Patient Device Satisfaction with eFlow Closed System Nebulizer: Results from the GOLDEN-5 Study in Patients with Moderate-to Very-Severe Chronic Obstructive Pulmonary Disease (COPD) (ATS 2017) - "In this study, patients reported high rates of device satisfaction with SUN-101 administered via the eFlow nebulizer system, and a majority were satisfied with overall device performance and confident in drug delivery. These findings support the eFlow system as a potential delivery system for SUN-101 in maintenance treatment of patients with moderate-to-very severe COPD."

Clinical • Biosimilar • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology

Improvement in Respiratory Symptoms in Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease Patients Treated With SUN-101 (glycopyrrolate/eflow®) – Patient-Reported Outcomes From the Phase 3 GOLDEN Studies (ATS 2017) - "Treatment of moderate-to-very severe COPD patients with SUN-101 25 mcg and 50 mcg twice-daily resulted in improvements in COPD respiratory symptoms that were maintained throughout these studies."

Clinical • P3 data • Biosimilar • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology

"@US_FDA accepts for review resubmission of NDA for @Sunovion's SUN-101/eFlow® (glycopyrrolate) for long term, maintenance tx of COP" (@NewAdisInsight)

Clinical • Biosimilar