US EPA

2262816 

Journal Article 

Abstract 

Budesonide/formoterol maintenance and reliever therapy at two different maintenance doses: effect on fractional excretion of nitric oxide (FENO) 

Brusselle, GG; Kardos, P; Louis, R; Schmoller, T; Jorgensen, L; Aubier, M; Haughney, J; van Schayck, CP; Ekstrom, T; Buhl, R 

2010 

Yes 

American Journal of Respiratory and Critical Care Medicine
ISSN: 1073-449X
EISSN: 1535-4970 

181 

A5407 

English 

10.1164/ajrccm-conference.2010.181.1_MeetingAbstracts.A5407 

WOS:000208771003484 

is part of a larger document 3452678 Proceedings of the American Thoracic Society 2010 International Conference, May 14-19, 2010, New Orleans

Rationale: In a pan-European, randomized (n = 8,424), open-label, 6-month study (ClinicalTrials.gov identifier NCT00463866), the efficacy and safety of budesonide/formoterol (Symbicort Turbuhaler) maintenance and reliever therapy (Symbicort SMART) at the standard (160/4.5 µg twice daily [bid]; 1x2) or the highest (2x160/4.5 µg bid; 2x2) recommended maintenance doses were examined in adult asthma patients symptomatic on inhaled corticosteroid (ICS) or ICS plus a long-acting β2-agonist (LABA).

Methods: The fractional excretion of nitric oxide (FENO), a marker of eosinophilic airway inflammation, was measured in parts per billion (ppb) at baseline and during the study (NIOX MINO) in a subgroup of 228 patients (mean age 49 years, females 63%, forced expiratory volume in 1 second 89% predicted normal, ICS dose 975 µg/day [beclomethasone dipropionate equivalents]). Changes in FENO were compared between treatments using a multiplicative analysis of variance model with treatment as fixed factor and the baseline value as a log-transformed covariate.

Results: FENO at baseline followed a log normal distribution with geometric mean (coefficient of variation) of 24.6 (2.3) ppb in 1x2 and 20.7 (2.5) ppb in 2x2 (difference at baseline: 3.9). FENO at baseline was the most important covariate, influencing FENO change from baseline to end of study. FENO was significantly decreased (geometric mean) at 6 months vs. baseline, to 21.0 ppb in 1x2 (P<0.001) and 16.2 ppb in 2x2 (P<0.001), although the steroid intake was substantially reduced in 1x2 during the study. The difference between treatments, while statistically significant (P=0.042), was small and within the range associated with good clinical control.

Conclusion: Budesonide/formoterol maintenance and reliever therapy, given either as a standard or the highest maintenance dose, significantly reduces the fractional excretion of nitric oxide in adult asthma patients symptomatic on ICS ± LABA.
Disclosure: This analysis was funded by AstraZeneca. 

American Thoracic Society 2010 International Conference 

New Orleans, LA 

May 14-19, 2010