Glycopyrronium 7.2micrograms/dose / Formoterol 5micrograms/dose inhaler CFC free

AIM: This study aims to systematically evaluate which single-inhaler triple therapy (inhaled corticosteroids [ICS], long-acting β2-agonists [LABA], and long-acting muscarinic antagonists [LAMA]) is safer and more effective for treating chronic obstructive pulmonary disease (COPD). METHODS: A comprehensive search was performed in PubMed, Embase, Ovid, Cochrane library and Google Scholar from database establishment to November 2025. Searches were limited to English articles. The RCTs that compared single-inhaler triple therapy (ICS/LABA/LAMA) with triple therapy (ICS/LABA+LAMA) or dual therapy (ICS/LABA or LABA/LAMA) for COPD were included. Minimum duration ≥ 12 weeks and minimum participant numbers ≥ 300 patients. Outcomes included forced expiratory volume in 1 s (FEV1), moderate and severe exacerbations, St George’s Respiratory Questionnaire (SGRQ) total score and SGRQ responders, transition dyspnea index (TDI) focal score and safety. RESULTS: 12 RCTs (n = 28930 patients) were included in this network meta-analysis. Fluticasone furoate/vilanterol/umeclidinium (FF/VIL/UMEC) was statistically significantly more effective at increasing trough FEV1 (based on change from baseline) than dual therapies (ICS/LABA or LABA/LAMA), free triple therapy (ICS/LABA+LAMA), budesonide/formoterol fumarate/glycopyrronium bromide (BUD/FOR/GLY) and beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FOR/GLY). In addition, FF/VIL/UMEC, BUD/FOR/GLY, and free triple therapy (ICS/LABA+LAMA) showed significant improvement in the total SGRQ score to dual therapies (ICS/LABA or LABA/LAMA). FF/VIL/UMEC and free triple therapy (ICS/LABA+LAMA) showed borderline significant improvement in the total SGRQ score to BDP/FOR/GLY. CONCLUSION: The four available single-inhaler triple therapies and free triple therapy appear to have similar effectiveness and safety. Given the absence of direct comparison studies differences cannot be found with a sufficient level of certainty. Further analysis is needed, as additional evidence becomes available.

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Hyperhidrosis (HH), characterized by excessive sweating, poses a significant challenge to patients’ quality of life. This meta-analysis evaluates the safety and efficacy of topical glycopyrronium bromide (GBP) in treating primary hyperhidrosis, a chronic condition affecting various body regions. Despite its prevalence, primary axillary hyperhidrosis is often undertreated due to a lack of awareness and social stigma. Following PRISMA guidelines, we conducted a systematic review and meta-analysis of randomized controlled trials comparing GBP to a placebo in primary hyperhidrosis patients. Eligibility criteria included outcomes related to perspiration suppression and symptom improvement. Four RCTs involving 1401 patients were included. GBP significantly increased Hyperhidrosis Disease Severity Scale (HDSS) responders (RR = 2.33, 95% CI [1.99 to 2.74], p < 0.00001) and Axillary Sweating Daily Diary (ASDD/ASDD-C) responders (MD = 3.07, 95% CI [2.32 to 4.06], p < 0.002) without significantly causing adverse events. Dermatology life quality index was also significantly improved in the GBP group (MD = -2.32, 95% CI [-3.09, -1.55], P < 0.00001). GBP demonstrated effectiveness in reducing sweat production while improving HDSS and DLQI scores. Adverse events included dry mouth and anticholinergic effects. Dry eye and local skin reactions were not significant, which makes GBP promising in managing primary hyperhidrosis, offering improvements in symptoms and quality of life. While adverse events should be considered, further research with larger sample sizes and long-term follow-up is warranted for comprehensive clinical integration. • We found that topical glycopyrronium can be an effective treatment for hyperhidrosis, reducing sweat production and improving patients’ symptoms. • We also found that the increase in certain adverse events necessitates careful consideration in clinical decision-making.

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Introduction The efficacy of the fixed extrafine combination of beclomethasone/formoterol/glycopyrronium (BDP/FF/G 87/5/9 μg) has been evaluated in randomized controlled trials of patients with chronic obstructive pulmonary disease (COPD). However, only few data exist on its effectiveness on small airways dysfunction (SAD). Methods The MASCOT (MAnaging Small airways dysfunction in COPD patients in real life on the fixed Triple combination of BDP/FF/G 87/5/9 μg pMDI) prospective observational study evaluated the effectiveness of this combination on SAD in a period of 4 weeks, after direct switch from long-acting β2-agonists (LABA) and long-acting muscarinic antagonists (LAMA) in COPD patients with SAD (forced expiratory flow at 25–75% of the vital capacity, FEF25-75% <60% predicted). The primary endpoint was improvement in R5-19 in oscillometry; secondary endpoints included other oscillometry parameters, lung function and health status (COPD assessment test-CAT, Saint-George’s Respiratory Questionnaire-SGRQ). Results Between May 2022 and July 2023 we recruited 93 COPD patients (mean age 68.5 years, 82% men) with forced expiratory volume in 1 second (FEV1, mean ± SD) 1.53 ± 0.47L (53.4 ± 14.5% predicted) and small airways dysfunction (FEF25-75% predicted 27.7 ± 15.4%). We observed statistically significant improvement in R5-19 between baseline (V1) and follow-up (V2) visits [median (IQR) V2 0.70 (0.41–1.10) vs V1 0.90 (0.60–1.83); mean change (95% CI) −0.49, −0.66 to −0.33 cmH2O/L/sec, p < 0.0001). There were improvements in multiple parameters, including FEF25-75% (3.43, 1.20% to 5.66%, p = 0.0005), FEV1 (0.142, 0.078 to 0.205 L, p < 0.0001) and RV/TLC (−6.09, −9.61% to −2,56% predicted, p < 0.0001), as well as improvement in CAT score −4.09 (−5.09 to −3.08) και SGRQ total score (−8.75, −11.58 to −5.93 points, p < 0.0001). Conclusion Extrafine triple therapy improved SAD and spirometric parameters, leading to improvement in health status at 4 weeks. These results need to be confirmed in longer studies.

Abstract licence: CC BY-NC

BackgroundCOPD and cardiovascular disease (CVD) are leading causes of death with overlapping and syndemic pathophysiological interactions. Inhaled triple therapies containing inhaled corticosteroids (ICS), long-acting muscarinic antagonists (LAMA) and long-acting β2-agonists (LABA) reduce COPD exacerbation rates and improve lung function versus dual LAMA/LABA therapy. The effect of inhaled triple therapies on combined cardiac and pulmonary (i.e., cardiopulmonary) events in people with COPD and elevated cardiopulmonary risk has not been prospectively tested in randomised clinical trials.MethodsTHARROS is a multinational, event-driven cardiopulmonary outcomes trial evaluating budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) triple therapy versus glycopyrronium/formoterol fumarate dihydrate dual therapy in patients with COPD and elevated cardiopulmonary risk not using ICS-containing maintenance therapy. Eligibility requirements include symptomatic COPD (COPD Assessment Test scores ≥10) without a requirement for prior COPD exacerbations, blood eosinophils ≥100 cells·mm-3, established CVD or CVD risk based on clinical characteristics, clinical risk scores or imaging-based risk criteria. The composite primary end-point is time to first severe cardiac or COPD event and includes three event types, including severe cardiac events (heart failure acute healthcare visit/hospitalisation, myocardial infarction hospitalisation), severe COPD exacerbations and cardiopulmonary death. Approximately 5000 patients will be randomised to achieve 632 participants with ≥1 primary severe adjudicated cardiopulmonary event.ConclusionThis first-of-its-kind cardiopulmonary outcomes trial will determine the effect of BGF on a novel composite end-point comprising severe cardiopulmonary events in a broad COPD population with elevated cardiopulmonary risk not currently using ICS-containing maintenance therapy.

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