Trimbow pMDI 87/5/9 Patient Information Leaflet. Fostair NEXThaler 100/6 Summary of Product Characteristics. Fostair pMDI 100/6 Summary of Product Characteristics. Quality Standard QS10: Chronic obstructive pulmonary disease in adults. Trimbow NEXThaler 88/5/9 Summary of Product Characteristics. Trixeo Aerosphere (formoterol fumarate dihydrate/glycopyrronium bromide/ budesonide) is a. Trimbow pMDI 87/5/9 Summary of Product Characteristics. LABA+ICS inhalers are available for COPD. TDI: transition dyspnea index TEAE: treatment-emergent adverse event.ġ. SAE: serious adverse event SDDPI: single-dose dry powder inhaler SPC: summary of product characteristics PIL: patient information leaflet pMDI: pressurised metered dose inhaler RR: rate ratio RRR: relative risk reduction Soft mist inhalers these produce an aerosol but use spring power instead of propellant pressurised. Sometimes they come in separate inhalers and sometimes in combinations. Most people with COPD who are breathless will benefit from taking both kinds. NI: Northern Ireland NYHA: New York Heart Association o.d.: once daily PIFR: peak inspiratory flow rate They are called long-acting anti-muscarinic (LAMA) and long-acting beta agonist (LABA). MI: myocardial infarction N: number of patients in the intention-to-treat/safety population n: number of patients LABA: long-acting β 2-agonist LAMA: long-acting muscarinic antagonist MACE: major adverse cardiovascular event 6,7ĪDR: adverse drug reaction AE: adverse event ARR: absolute risk reduction AUC 0–12: area under the curve between 0 and 12 hours ī.d.: twice daily CI: confidence interval COPD: chronic obstructive pulmonary disease ĭPI: dry powder inhaler FEV 1: forced expiratory volume in one second GB: Great Britain ICS: inhaled corticosteroid
Trimbow pMDI 87/5/9 and Trimbow NEXThaler 88/5/9 are not licensed as step-up treatment for COPD patients on a LAMA only.įostair 100/6 is indicated for symptomatic treatment of patients with severe COPD (FEV 1<50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. Fostair pMDI 100/6 was met in change from baseline in pre-dose morning FEV 1 (p<0.001), change from baseline in 2-h post-dose FEV 1 (p<0.001), but unmet for TDI focal score (p=0.160), all assessed at week 26 (N=1368). 11Ĭo-primary endpoints of TRILOGY: Superiority of Trimbow pMDI 87/5/9 vs. LABA/LAMA (Ultibro ® Breezhaler ® 85/43 mcg). LABA/LAMA combination inhalers were not available at the time this guidance was developed, and were not considered by NICE.).ICS/LABA (Fostair pMDI 100/6) – secondary endpoint 10.LAMA (Spiriva ® HandiHaler ® 18 mcg) 9.Trimbow pMDI 87/5/9 demonstrated reduction in moderate to severe exacerbations vs.: 1.In the TRI-D study, Trimbow NEXThaler 88/5/9 and Trimbow pMDI 87/5/9 demonstrated similar efficacy and were generally well tolerated 8.Choice of pMDI or NEXThaler device to help meet your patients’ needs 1,2.Extrafine formulation like Fostair ®(beclometasone/formoterol) 1,2,6,7.In adult patients with moderate to severe COPD not adequately treated with a combination of an ICS/LABA or LABA/LAMA, Trimbow offers:
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