Foradil Aerolizer (formoterol dry powder inhaler) / Novartis, Merck (MSD) - LARVOL DELTA

TICTAC: Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients At High Risk of Postoperative Pulmonary Complications (clinicaltrials.gov) - P=N/A | N=266 | Not yet recruiting | Sponsor: Centre Hospitalier Universitaire, Amiens

New trial

Effect of Gly16Arg Polymorphism in ADRB2 Gene on Asthma Control in Children Receiving Long Acting Beta Agonists (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Nemours Children's Clinic | Terminated ➔ Withdrawn

Trial withdrawal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

BufoSwitch: Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway (clinicaltrials.gov) - P; N=1000; Not yet recruiting; Sponsor: Orion Corporation, Orion Pharma

New trial • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Variability in airway inflammation, symptoms, lung function and reliever use in asthma: anti-inflammatory reliever hypothesis and STIFLE study design. (PubMed, ERJ Open Res) - "Participants will be randomised 1:1 to either as-needed budesonide/formoterol dry-powder inhaler or salbutamol reliever for 24 weeks, in addition to their maintenance therapy. Daily data will be captured for fractional exhaled nitric oxide, spirometry, asthma symptoms and medication use using devices connected to a smartphone via the STIFLE application. STIFLE will thereby enable not only characterisation of the variability of airway inflammation and clinical outcomes in relation to asthma worsening, but also elucidate the effect of as-needed budesonide/formoterol on airway inflammation against a background of daily maintenance therapy."

Journal • Asthma • Immunology • Respiratory Diseases

Estimated lifetime effectiveness of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) versus dual LAMA/LABA and ICS/LABA therapies in moderate-to-very severe COPD (ERS 2019) - P3; "Objective: To estimate the lifetime clinical effectiveness of BGF MDI versus LAMA/LABA (glycopyrrolate/formoterol fumarate MDI) and ICS/LABA (budesonide/formoterol dry powder inhaler) therapies in patients with moderate-to-very severe COPD. Modelling using KRONOS data demonstrated better outcomes with BGF MDI versus dual therapies over a lifetime, particularly in reducing exacerbations, for patients with COPD."

Efficacy and Safety of Inhaled Triple Therapy Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Versus Dual Therapies in Chinese Patients with Moderate-to-Very Severe COPD (ATS 2019) - P3; "Methods : In this double-blind, parallel-group study, patients who remained symptomatic despite using ≥2 inhaled maintenance therapies were randomized 2:2:1:1 to BGF MDI 320/18/9.6µg, GFF MDI 18/9.6µg, BFF MDI 320/9.6µg (all formulated using co‑suspension delivery technology), or open-label budesonide/formoterol dry powder inhaler (DPI) 400/12µg twice daily for 24 weeks. In the KRONOS China subgroup, lung function, symptom and exacerbation benefits of BGF MDI versus BFF MDI and GFF MDI were generally consistent with the global study population. There were no new or unexpected safety findings. Overall, these results support the use of BGF MDI in Chinese patients with moderate-to-very severe COPD."

Clinical

Seasonal Variation in COPD Exacerbations: a Post-Hoc Analysis from the KRONOS Phase III Study of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) (ATS 2019) - P3; "We analyzed data from patients in the modified intent-to-treat (mITT) population receiving BGF MDI 320/18/9.6 μg (n=639), GFF MDI 18/9.6 μg (n=625), BFF MDI 320/9.6 μg (n=314), or open-label budesonide/formoterol dry powder inhaler 400/12 μg (BUD/FORM DPI; n=318). In this population of patients with symptomatic, moderate-to-very severe COPD with no requirement for a history of exacerbations in the previous year, seasonal variation in exacerbation rate occurred within each treatment group. The significant reduction in annualized exacerbation rates with BGF MDI versus GFF MDI was consistently observed across all four seasons, indicating that the 6‑month study duration provided a robust assessment of COPD exacerbation rates."

P3 data • Retrospective data

Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology. (PubMed, Pulm Pharmacol Ther) - P2; "No clinically significant effects on cardiovascular safety occurred at therapeutic or supratherapeutic doses of GFF MDI, apart from a small and transient increase in heart rate following supratherapeutic dose of GFF MDI 144/38.4 μg. Furthermore, there were no unexpected safety findings reported in either healthy volunteers or patients with COPD."

Clinical • Journal

Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study. (PubMed, BMC Pulm Med) - P=N/A; "In the cross-sectional phase, a significantly greater proportion of patients using Spiromax versus Turbuhaler achieved device mastery; in the longitudinal phase, the proportion of patients maintaining device mastery with Spiromax versus Turbuhaler was similar. An exploratory independent expert-verified analysis found Spiromax was associated with higher levels of device mastery after 12 weeks. Asthma control was improved by treatment with both BF Spiromax and BF Turbuhaler."

Clinical • Journal