Anne-Marie Kirsten1, Henrik Watz2, Caterina Brindicci3, Annalisa Piccinno3, Helgo Magnussen2. 1. Pulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany. Electronic address: a.kirsten@pulmoresearch.de. 2. Pulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany. 3. Chiesi Farmaceutici S.p.A., Parma, Italy.
Abstract
RATIONALE: Asthma is a chronic inflammatory airway disease of the whole bronchial tree. In this exploratory study we investigated the effects of beclomethasone/formoterol (becl/form) and budesonide/formoterol (bud/form) fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma. METHODS: 22 adult patients with asthma (mean FEV1 91.6% pred.) were recruited to this prospective phase IV, double-blind, double-dummy, two-way cross-over, single-centre, randomised study. After a 7 days run-in period with bud 200 μg bid patients were randomised to receive 4 weeks of becl/form (100/6 μg) bid in a pressurised metered dose inhaler or bud/form (160/4.5 μg) bid administered via dry powder inhaler. We measured spirometry, bodyplethysmography, impulse oscillometry, nitric oxide (NO) and its alveolar fraction (CAlv), and assessed sputum cellularity. RESULTS:CAlv significantly decreased after 4 weeks of treatment in each treatment period. The adjusted geometric mean (log transformed data, end of treatment vs. baseline) was 0.942 ppb (95% CI: 0.778-1.141 ppb) for becl/form and 0.903 ppb (95% CI: 0.741-1.099 ppb) for bud/form. Impulse oscillometry revealed a significant decrease in mean Delta R5-R20 of -0.033 kPa * L(-1) * sec(-1) for becl/form (95% CI: -0.064 to -0.002) and of -0.048 033 kPa * L(-1) * sec(-1) for bud/form (95% CI: -0.079 to -0.017). Other parameters of lung function and NO showed numerically small and in most cases statistically non-significant changes. CONCLUSIONS: In patients with mild to moderate asthma pre-treated withinhaled corticosteroids, the use of ICS/LABA formulations led to improvements of CAlv and Delta R5-R20 indicating that these parameters might be helpful to further assess the effects of inhaled ICS/LABA combinations on lung function and airway inflammation.
RCT Entities:
RATIONALE: Asthma is a chronic inflammatory airway disease of the whole bronchial tree. In this exploratory study we investigated the effects of beclomethasone/formoterol (becl/form) and budesonide/formoterol (bud/form) fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma. METHODS: 22 adult patients with asthma (mean FEV1 91.6% pred.) were recruited to this prospective phase IV, double-blind, double-dummy, two-way cross-over, single-centre, randomised study. After a 7 days run-in period with bud 200 μg bid patients were randomised to receive 4 weeks of becl/form (100/6 μg) bid in a pressurised metered dose inhaler or bud/form (160/4.5 μg) bid administered via dry powder inhaler. We measured spirometry, bodyplethysmography, impulse oscillometry, nitric oxide (NO) and its alveolar fraction (CAlv), and assessed sputum cellularity. RESULTS: CAlv significantly decreased after 4 weeks of treatment in each treatment period. The adjusted geometric mean (log transformed data, end of treatment vs. baseline) was 0.942 ppb (95% CI: 0.778-1.141 ppb) for becl/form and 0.903 ppb (95% CI: 0.741-1.099 ppb) for bud/form. Impulse oscillometry revealed a significant decrease in mean Delta R5-R20 of -0.033 kPa * L(-1) * sec(-1) for becl/form (95% CI: -0.064 to -0.002) and of -0.048 033 kPa * L(-1) * sec(-1) for bud/form (95% CI: -0.079 to -0.017). Other parameters of lung function and NO showed numerically small and in most cases statistically non-significant changes. CONCLUSIONS: In patients with mild to moderate asthma pre-treated with inhaled corticosteroids, the use of ICS/LABA formulations led to improvements of CAlv and Delta R5-R20 indicating that these parameters might be helpful to further assess the effects of inhaled ICS/LABA combinations on lung function and airway inflammation.
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: 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