Once-Daily Tiotropium Respimat Add-on to Medium-Dose Inhaled Corticosteroids Improves Lung Function and Asthma Control in Adult Patients With Moderate Symptomatic Asthma, Independent of Prior Long-Acting _2-Agonist Use

CHEST Journal ◽  
2015 ◽  
Vol 148 (4) ◽  
pp. 732A ◽  
Author(s):  
Leon Greos ◽  
William Berger ◽  
Petra Moroni-Zentgraf ◽  
Michael Engel ◽  
Reinhold Luehmann ◽  
...  
CHEST Journal ◽  
2013 ◽  
Vol 144 (4) ◽  
pp. 89A ◽  
Author(s):  
Jonathan A Bernstein ◽  
Huib AM Kerstjens ◽  
Petra Moroni-Zentgraf ◽  
Michael Engel ◽  
Hendrik Schmidt ◽  
...  

CHEST Journal ◽  
2013 ◽  
Vol 144 (4) ◽  
pp. 90A ◽  
Author(s):  
Donald P Tashkin ◽  
Petra Moroni-Zentgraf ◽  
Michael Engel ◽  
Hendrik Schmidt ◽  
Huib AM Kerstjens

2015 ◽  
Vol 1 (1) ◽  
pp. 00022-2015 ◽  
Author(s):  
Tari Haahtela ◽  
Olof Selroos ◽  
Paul M. O'Byrne

The term “early intervention” with inhaled corticosteroids (ICS) in asthma is used in different ways, thereby causing confusion and misinterpretation of data. We propose that the term should be reserved for start of ICS therapy in patients with a diagnosis of asthma but within a short period of time after the first symptoms, not from the date of diagnosis. Prospective clinical studies suggest a time frame of 2 years for the term “early” from the onset of symptoms to starting anti-inflammatory treatment with ICS.The current literature supports early intervention with ICS for all patients with asthma including patients with mild disease, who often have normal or near-normal lung function. This approach reduces symptoms rapidly and allows patients to achieve early asthma control. Later introduction of ICS therapy may not reduce effectiveness in terms of lung function but delays asthma control and exposes patients to unnecessary morbidity. Results of nationwide intervention programmes support the early use of ICS, as it significantly minimises the disease burden.Acute asthma exacerbations are usually preceded by progressing symptoms and lung function decline over a period of 1–2 weeks. Treatment with an increased dose of ICS together with a rapid- and long-acting inhaled β2-agonist during this phase has reduced the risk of severe exacerbations.


2016 ◽  
Vol 49 (1) ◽  
pp. 1601100 ◽  
Author(s):  
Eckard Hamelmann ◽  
Jonathan A. Bernstein ◽  
Mark Vandewalker ◽  
Petra Moroni-Zentgraf ◽  
Daniela Verri ◽  
...  

We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma.In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12–17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV1) within 3 h post-dosing (FEV1(0–3h)) and trough FEV1, respectively, after 12 weeks of treatment.Tiotropium 5 µg provided numerical improvements in peak FEV1(0–3h) response, compared with placebo (90 mL; p=0.104), and significant improvements were observed with tiotropium 2.5 µg (111 mL; p=0.046). Numerical improvements in trough FEV1 response and asthma control were observed with both tiotropium doses, compared with placebo. The safety and tolerability of tiotropium were comparable with those of placebo.Once-daily tiotropium Respimat add-on to ICS plus one or more controller therapies in adolescents with severe symptomatic asthma was well tolerated. The primary end-point of efficacy was not met, although positive trends for improvements in lung function and asthma control were observed.


2021 ◽  
Vol 8 (1) ◽  
pp. e000856 ◽  
Author(s):  
Hironori Sagara ◽  
Nathalie Barbier ◽  
Tsuyoshi Ishii ◽  
Hajime Yoshisue ◽  
Ivan Nikolaev ◽  
...  

Background and objectiveThe 52-week IRIDIUM study demonstrated the efficacy of indacaterol acetate/glycopyrronium bromide/mometasone furoate (IND/GLY/MF) versus IND/MF and salmeterol xinafoate/fluticasone propionate (SAL/FLU) in patients with symptomatic asthma, despite long-acting β2-agonist/inhaled corticosteroids (LABA/ICS) medium-dose or high-dose, predicted forced expiratory volume in 1 s (FEV1) <80% and at least one exacerbation in the previous year. Here, we present data from a post hoc analysis of the IRIDIUM study in the Asian subpopulation.MethodsThis post hoc analysis evaluated improvements in lung function, asthma control and reduction in asthma exacerbations with IND/GLY/MF medium- (150/50/80 µg) and high-dose (150/50/160 µg) versus IND/MF medium- (150/160 µg) and high-dose (150/320 µg), all one time per day and SAL/FLU high-dose (50/500 µg) two times per day, in Asian patients from the IRIDIUM study.ResultsIn total, 258 patients (IND/GLY/MF medium-dose, 52; IND/GLY/MF high-dose, 52; IND/MF medium-dose, 51; IND/MF high-dose, 51; SAL/FLU high-dose, 52) were included. IND/GLY/MF medium- and high-dose showed greater improvement in trough FEV1 at week 26 versus respective doses of IND/MF (Δ, 100 mL and 101 mL; both p<0.05, respectively), and SAL/FLU high-dose (Δ, 125 mL; p=0.0189, and 136 mL; p=0.0118, respectively), which were maintained over 52 weeks. Both doses of IND/GLY/MF showed greater improvement in morning and evening peak expiratory flow versus respective doses of IND/MF and SAL/FLU high-dose at week 52. The changes in Asthma Control Questionnaire-7 scores from baseline were comparable in all treatment groups. IND/GLY/MF medium- and high-dose showed greater reductions in severe (34%, 69%), moderate or severe (18%, 54%) and all exacerbations (21%, 34%) compared with SAL/FLU high-dose over 52 weeks.ConclusionOne time per day, single-inhaler IND/GLY/MF improved lung function, reduced asthma exacerbations and provided comparable asthma control versus IND/MF and SAL/FLU in Asian patients with inadequately controlled asthma despite LABA/ICS. The results of this analysis were consistent with the overall population in the IRIDIUM study.


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