formoterol fumarate (PT005) / AstraZeneca - LARVOL DELTA

Extending the Geographic Range of Pterosaurs in the Araripe Basin: First Record from the Romualdo Formation (Araripe Basin) in Piauí, Brazil. (PubMed, An Acad Bras Cienc) - "This study reports the first pterosaur fossils from the Romualdo Formation in Piauí, represented by two three-dimensionally preserved, incomplete wing phalanges: LPP Pt-002 and LPP Pt-005...These differences indicate that the specimens represent distinct individuals. Although the reasons for the lower abundance of pterosaur remains in the southern Araripe Basin are unclear, these findings expand the known geographic range of Pterosauria within the basin and underscore the importance of further paleontological exploration in underrepresented regions to better understand pterosaur diversity and distribution during the Cretaceous."

Journal

Synthesis and Biological Evaluation of Novel MB327 Analogs as Resensitizers for Desensitized Nicotinic Acetylcholine Receptors after Intoxication with Nerve Agents. (PubMed, Toxicol Lett) - "By means of in silico studies based on our recently presented allosteric binding pocket at the nAChR, i.e. the MB327-PAM-1 binding site, three promising MB327 analogs with a 4-aminopyridinium ion partial structure (PTM0056, PTM0062 and PTM0063) were identified...More potent compounds were identified compared to MB327, as some of them showed a higher affinity towards MB327-PAM-1 and also a higher recovery of neuromuscular transmission at lower compound concentrations. To improve the treatment of organophosphate poisoning, direct targeting of nAChRs with appropriate compounds is a key step, and this study is an important contribution to this research."

Journal

PT005. Poster Spotlight Presentation (CPHM) Friday (ASM Microbe 2023) - No abstract available

PT005 - Join Pfizer | Learn About A Now Approved Oral Rx Treatment for Moderate-to-Severe Atopic Dermatitis (AAD 2022) - "Description Introducing CIBINQO™ (abrocitinib) for adults with refractory, moderate-to-sevIntroducing CIBINQO™ (abrocitinib) for adults with refractory, moderate-to-severe atopic dermatitis. Exhibiting Company: Pfizer, Inc. Theater 1: Booth 4471"

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Incidence of oral thrush in patients with COPD prescribed inhaled corticosteroids: Effect of drug, dose, and device. (PubMed) - Respir Med - "ICS use increases oral thrush incidence in COPD and this effect is dose-dependent for FP/SAL therapies. Of the therapies assessed, FP/SAL pMDI and BUD/FOR DPI may be more protective against oral thrush."

Journal • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology

Activated protein phosphatase PP2A by formoterol enhances nuclear translocation of glucocorticoid receptor induced by budesonide (ERS 2011) - FM directly activates PP2A in a β2-adrenoceptor-independent manner; PP2A overexpression enhanced BUD-induced GR translocation and further increased enhancement of GR translocation by formoterol (FM)

MOA • Asthma

Lung Deposition of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Administered Via pMDI in Healthy, Asthmatic and COPD Patients (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Chiesi Farmaceutici S.p.A.

New P1 trial • Asthma • Biosimilar • Chronic Obstructive Pulmonary Disease • Gene Therapies • Immunology

A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma (clinicaltrials.gov) - P3; N=422; Not yet recruiting; Sponsor: GlaxoSmithKline

New P3 trial • Asthma • Biosimilar • Immunology • Inflammation

Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Patients With Asthma (clinicaltrials.gov) - P4; N=400; Active, not recruiting; Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.; Recruiting -> Active, not recruiting ; N=500 -> 400

Enrollment change • Enrollment closed • Asthma • Biosimilar • Immunology • Inflammation

Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2) (clinicaltrials.gov) - P3; N=1376; Recruiting; Sponsor: Pearl Therapeutics, Inc.; Not yet recruiting -> Recruiting

Enrollment open • Biosimilar • Immunology

Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD (clinicaltrials.gov) - P3; N=138; Completed; Sponsor: Pearl Therapeutics, Inc.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation

FLASH: A Dose Ranging Study of CHF 1531 in Asthmatic Subjects (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Chiesi Farmaceutici S.p.A.; Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Biosimilar • Gene Therapies • Immunology

A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma (clinicaltrials.gov) - P3; N=423; Completed; Sponsor: GlaxoSmithKline; Recruiting ➔ Completed

Trial completion • Asthma • Biosimilar • Immunology

AVANT: Study to Patients With Stable COPD to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate (DUAKLIR) (clinicaltrials.gov) - P3; N=1060; Recruiting; Sponsor: AstraZeneca; Trial completion date: Mar 2019 ➔ Jul 2019; Trial primary completion date: Mar 2019 ➔ Jul 2019

Trial completion date • Trial primary completion date • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology

BOTH: The Effect of Twice Daily vs. Once Daily Bronchodilation on Hyperinflation in COPD Patients During 24 Hours. (clinicaltrials.gov) - P4; N=49; Recruiting; Sponsor: Maastricht University Medical Center; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Chronic Obstructive Pulmonary Disease

ACTIVATE: EFFECT OF ACLIDINIUM/FORMOTEROL ON LUNG HYPERINFLATION, EXERCICE CAPACITY AND PHYSICAL ACTIVITY IN MODERATE TO SEVERE COPD PATIENTS (clinicaltrials.gov) - P4; N=269; Recruiting; Sponsor: AstraZeneca; Trial primary completion date: Apr 2016 ➔ Jul 2016

Trial primary completion date • Biosimilar • Chronic Obstructive Pulmonary Disease

Microbiome Use to Stratify Use of Inhaled Corticosteroids: MUSIC Trial (clinicaltrials.gov) - P4; N=200; Recruiting; Sponsor: University of Dundee; Trial completion date: May 2018 ➔ Apr 2020; Trial primary completion date: May 2018 ➔ Apr 2020

Trial completion date • Trial primary completion date • Biosimilar • Chronic Obstructive Pulmonary Disease

A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Pearl Therapeutics, Inc.; Trial completion date: Dec 2017 ➔ Apr 2018; Trial primary completion date: Dec 2017 ➔ Dec 2017

Trial completion date • Trial primary completion date • Biosimilar • Chronic Obstructive Pulmonary Disease

Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3; N=3686; Active, not recruiting; Sponsor: Chiesi Farmaceutici S.p.A.; Recruiting -> Active, not recruiting

Enrollment closed • Biosimilar • Chronic Obstructive Pulmonary Disease

Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. (PubMed) - Lancet - P3; "We provide evidence for the clinical benefits of stepping up patients with COPD from an inhaled corticosteroid/long-acting β2-agonist combination treatment to triple therapy using a single inhaler."

Journal • Biosimilar • Chronic Obstructive Pulmonary Disease

24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI (clinicaltrials.gov) - P3; N=40; Not yet recruiting; Sponsor: Pearl Therapeutics, Inc.

New P3 trial • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation

Microbiome Use to Stratify Use of Inhaled Corticosteroids: MUSIC Trial (clinicaltrials.gov) - P4; N=200; Active, not recruiting; Sponsor: University of Dundee; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers (clinicaltrials.gov) - P3; N=43; Completed; Sponsor: McGill University Health Center; Recruiting ➔ Completed; Trial completion date: Jul 2019 ➔ Feb 2019

Clinical • Trial completion • Trial completion date

TRI-D: Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2; N=366; Completed; Sponsor: Chiesi Farmaceutici S.p.A.; Recruiting ➔ Completed

Clinical • Trial completion

A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD (clinicaltrials.gov) - P3; N=20; Recruiting; Sponsor: AstraZeneca; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open