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Abstract
Objective
When selecting inhaled therapies, it is important to consider both the active molecules and the device. Extrafine formulation beclomethasone dipropionate plus formoterol fumarate (BDP/FF) has been available for some years delivered via pressurized metered-dose inhaler (pMDI). More recently, a breath-activated, multi-dose dry-powder inhaler (DPI), the NEXThaler, has been approved. The current study aimed to demonstrate the non-inferiority of BDP/FF delivered via the DPI vs. via the pMDI, in Chinese adults with asthma.
Methods
After a four-week run-in period, when all patients received BDP/FF pMDI 100/6 µg, two inhalations twice daily (BID), patients were randomized equally to BDP/FF pMDI or DPI, both 100/6 µg, two inhalations BID for 12 weeks. The primary objective was to demonstrate non-inferiority of BDP/FF DPI vs. BDP/FF pMDI in terms of average pre-dose morning peak expiratory flow (PEF) over the entire treatment period.
Results
Of 252 and 242 patients in the DPI and pMDI groups, respectively, 88.5% and 88.8% completed the study. The primary objective was met, with no statistically significant difference between the treatments in average pre-dose morning PEF, and with the lower limit of the 95% CI above the −15 L/min non-inferiority margin (adjusted mean difference: 5.25 L/min [95% CI: −0.56, 11.06]). Adverse events were reported by 48.4% and 49.6% patients in the DPI and pMDI groups, respectively, most mild or moderate.
Conclusions
The NEXThaler DPI is a similarly effective device to the pMDI for the administration of BDP/FF in adults, so extending the options available for the management of asthma.
Declaration of interest
In addition to the medical writing support declared above, the authors have the following conflicts of interest to declare: Jinping Zheng declares advisory board membership with Chiesi, GlaxoSmithKline and AstraZeneca, all outside the scope of the current manuscript. Jianyong Zhang has no other declarations. Xiuhua Fu has no other declarations. Changqing Lin has no other declarations. Xinri Zhang has no other declarations. Xiaodong Mei has no other declarations. Massimo Corradi received a research contract from Chiesi Farmaceutici SpA during the conduct of the study. Glauco Cappellini is an employee of Chiesi Farmaceutici SpA, the sponsor of the study. Emanuele Calabro is an employee of Chiesi Farmaceutici SpA, the sponsor of the study. Cissy Zhu is an employee of Chiesi Pharmaceutical Consulting (Shanghai) Co. Ltd. Eva Topole is an employee of Chiesi Farmaceutici SpA, the sponsor of the study.
Data availability statement
Chiesi commits to sharing with qualified scientific and medical researchers, conducting legitimate research, the anonymized patient-level and study-level data, the clinical protocol and the full clinical study report of Chiesi Farmaceutici SpA-sponsored interventional clinical trials in patients for medicines and indications approved by the European Medicines Agency and/or the US Food and Drug Administration after 1 January 2015, following the approval of any received research proposal and the signature of a Data Sharing Agreement. Chiesi provides access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Other information on Chiesi’s data sharing commitment, access and research request’s approval process are available in the Clinical Trial Transparency section of http://www.chiesi.com/en/research-and-development/.