Effects of beclomethason/formoterol and budesonide/formoterol fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma – An exploratory study. (April 2015)

• Record Type: Journal Article
• Authors: Kirsten, Anne-Marie; Watz, Henrik; Brindicci, Caterina; Piccinno, Annalisa; Magnussen, Helgo
• Is Part Of: Pulmonary pharmacology & therapeutics. Volume 31(2015:Apr.)
• Page Start: 79
• Page End: 84
• Publication Date: 2015-04
• Subjects: Controlled asthma -- Inhaled corticosteroids/long-acting beta-2-agonists fixed combination -- Spirometry -- Bodyplethysmography -- Impulse oscillometry -- Nitric oxide measurements; Respiratory organs -- Diseases -- Chemotherapy -- Periodicals; 615.7205
• DOI: 10.1016/j.pupt.2014.08.007
• Languages: English
• ISSNs: 1094-5539

Abstract

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 ( C Alv ), and assessed sputum cellularity. Results: C Alv 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 C Alv 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.