BACKGROUND: The fixed combination of extrafine beclomethasone dipropionate and formoterol fumarate (BDP/FF) pMDI (Foster(®)) is approved for treatment of adult asthmatic patients. In order to provide an alternative drug delivery system for BDP/FF to physicians and patients, a dry powder inhaler (NEXThaler(®)) has been developed, capable to deliver extrafine particles to the lungs and therefore improve the dosing of the drugs, especially in patients with poor hand-breath coordination. OBJECTIVE: This trial was performed to compare efficacy and safety of extrafine BDP/FF NEXThaler(®) with extrafine BDP/FF pMDI or non-extrafine BDP DPI alone in adult patients with controlled asthma. METHODS: In this 8-week randomised, double-blind, parallel-group trial, patients were randomized to receive either extrafine BDP/FF NEXThaler(®) 100/6 μg bid, extrafine BDP/FF 100/6μg pMDI bid or non-extrafine BDP DPI 100 μg bid. The primary efficacy variable was change from baseline to the entire 8-week randomised treatment period in average pre-dose morning PEF. RESULTS: The ITT population comprised 754 patients. Extrafine BDP/FF NEXThaler(®) was non-inferior (pre-defined margin: -15 L/min) relative to extrafine BDP/FF pMDI (mean difference: -1.84; 95% CI: -6.73, 3.05) in terms of the primary efficacy variable, change from baseline in average pre-dose morning PEF. Statistical superiority of both extrafine BDP/FF formulations over non-extrafine BDP DPI was demonstrated for the primary efficacy variable (providing evidence of assays sensitivity of the trial), ACQ score and percentage of rescue medication use-free days. No significant safety signals were observed. CONCLUSION:NEXThaler(®) is an effective and well-tolerated delivery device for treatment of patients with asthma who need a regular treatment.
RCT Entities:
BACKGROUND: The fixed combination of extrafine beclomethasone dipropionate and formoterol fumarate (BDP/FF) pMDI (Foster(®)) is approved for treatment of adult asthmatic patients. In order to provide an alternative drug delivery system for BDP/FF to physicians and patients, a dry powder inhaler (NEXThaler(®)) has been developed, capable to deliver extrafine particles to the lungs and therefore improve the dosing of the drugs, especially in patients with poor hand-breath coordination. OBJECTIVE: This trial was performed to compare efficacy and safety of extrafine BDP/FF NEXThaler(®) with extrafine BDP/FF pMDI or non-extrafine BDPDPI alone in adult patients with controlled asthma. METHODS: In this 8-week randomised, double-blind, parallel-group trial, patients were randomized to receive either extrafine BDP/FF NEXThaler(®) 100/6 μg bid, extrafine BDP/FF 100/6 μg pMDI bid or non-extrafine BDPDPI 100 μg bid. The primary efficacy variable was change from baseline to the entire 8-week randomised treatment period in average pre-dose morning PEF. RESULTS: The ITT population comprised 754 patients. Extrafine BDP/FF NEXThaler(®) was non-inferior (pre-defined margin: -15 L/min) relative to extrafine BDP/FF pMDI (mean difference: -1.84; 95% CI: -6.73, 3.05) in terms of the primary efficacy variable, change from baseline in average pre-dose morning PEF. Statistical superiority of both extrafine BDP/FF formulations over non-extrafine BDPDPI was demonstrated for the primary efficacy variable (providing evidence of assays sensitivity of the trial), ACQ score and percentage of rescue medication use-free days. No significant safety signals were observed. CONCLUSION: NEXThaler(®) is an effective and well-tolerated delivery device for treatment of patients with asthma who need a regular treatment.
Authors: F Braido; N Scichilone; F Lavorini; O S Usmani; L Dubuske; L P Boulet; R Mosges; C Nunes; M Sanchez-Borges; I J Ansotegui; M Ebisawa; F Levi-Schaffer; L J Rosenwasser; J Bousquet; T Zuberbier; G Walter Canonica; A Cruz; A Yanez; A Yorgancioglu; D Deleanu; G Rodrigo; J Berstein; K Ohta; P Vichyanond; R Pawankar; S N Gonzalez-Diaz; S Nakajima; T Slavyanskaya; A Fink-Wagner; C Baez Loyola; D Ryan; G Passalacqua; J Celedon; J C Ivancevich; K Dobashi; M Zernotti; M Akdis; S Benjaponpitak; S Bonini; W Burks; L Caraballo; Z Awad El-Sayed; S Fineman; P Greenberger; E Hossny; J A Ortega-Martell; H Saito; M Tang; L Zhang Journal: World Allergy Organ J Date: 2016-10-28 Impact factor: 4.084
Authors: Dave Singh; Frans van den Berg; Brian Leaker; Massimo Corradi; Sunny Jabbal; Sara Collarini; Valentina Mongelli; Luigi Santoro; Annalisa Piccinno; Sonia Biondaro; Brian Lipworth Journal: Br J Clin Pharmacol Date: 2019-02-03 Impact factor: 4.335
Authors: F Braido; N Scichilone; F Lavorini; O S Usmani; L Dubuske; L P Boulet; R Mosges; C Nunes; M Sánchez-Borges; I J Ansotegui; M Ebisawa; F Levi-Schaffer; L J Rosenwasser; J Bousquet; T Zuberbier; G Walter Canonica Journal: Asthma Res Pract Date: 2016-10-28