Back to Search
Start Over
Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler(®)) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial.
- Source :
-
Pulmonary pharmacology & therapeutics [Pulm Pharmacol Ther] 2015 Feb; Vol. 30, pp. 121-7. Date of Electronic Publication: 2014 Aug 01. - Publication Year :
- 2015
-
Abstract
- 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.<br />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.<br />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 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.<br />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.<br />Conclusion: NEXThaler(®) is an effective and well-tolerated delivery device for treatment of patients with asthma who need a regular treatment.<br /> (Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Subjects :
- Administration, Inhalation
Adolescent
Adult
Aged
Anti-Asthmatic Agents administration & dosage
Anti-Asthmatic Agents adverse effects
Beclomethasone administration & dosage
Beclomethasone adverse effects
Double-Blind Method
Dry Powder Inhalers
Ethanolamines administration & dosage
Ethanolamines adverse effects
Female
Formoterol Fumarate
Humans
Male
Metered Dose Inhalers
Middle Aged
Particle Size
Treatment Outcome
Young Adult
Anti-Asthmatic Agents therapeutic use
Asthma drug therapy
Beclomethasone therapeutic use
Ethanolamines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1522-9629
- Volume :
- 30
- Database :
- MEDLINE
- Journal :
- Pulmonary pharmacology & therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 25088067
- Full Text :
- https://doi.org/10.1016/j.pupt.2014.07.006