scholarly journals Salmeterol and Fluticasone Propionate (50/250 μg) Administered via Combination Diskus Inhaler: As Effective as When Given via Separate Diskus Inhalers

1999 ◽  
Vol 6 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Kenneth R Chapman ◽  
Nils Ringdal ◽  
Vibeke Backer ◽  
Mona Palmqvist ◽  
Seppo Saarelainen ◽  
...  
Keyword(s):  
Fluticasone Propionate ◽  
Inhaled Corticosteroids ◽  
Safety Data ◽  
Serum Cortisol ◽  
Forced Expiratory Volume ◽  
New Combination ◽  
Double Blind ◽  
Asthma Patients ◽  
Symptomatic Asthma ◽  
The Difference

OBJECTIVE: To compare the efficacy and safety of a new combination Diskus inhaler containing both salmeterol 50 μg and fluticasone propionate 250 μg (Seretide) with the two drugs delivered via separate Diskus inhalers.DESIGN: A multicentre, double-blind, double-dummy study. Three hundred and seventy-one symptomatic asthma patients (age range 13 to 75 years, mean 42 years) receiving inhaled corticosteroids were randomly assigned to two treatement groups: 28 weeks’ treatment with either salmeterol/fluticasone propionate (50/250 μg bid) via a single Diskus inhaler (combination) and placebo bid via another Diskus inhaler, or salmeterol 50 μg bid via one Diskus inhaler and fluticasone propionate 250 μg bid via another (concurrent). Morning peak expiratory flow rate (PEFR) and symptoms were measured for the first 12 weeks and safety data were collected throughout the study.RESULTS: Over weeks 1 to 12, adjusted mean improvements in morning PEFR were 43 and 36 L/min for combination and concurrent therapies, respectively. The difference between the two treatment arms was 6 L/min (90% CI –13 to 0 L/min; P=0.114), which was within the predefined criteria for clinical equivalence. Adjusted mean improvements in forced expiratory volume in 1 s from baseline for week 28 were also similar between the two therapies. Thirty-five per cent of patients receiving combination inhaler and 31% of those receiving concurrent therapy had a mean daytime symptom score of zero over weeks 1 to 12 compared with 1% and 2%, respectively, at baseline. There was no difference in the incidence of adverse events between the two treatment arms. Mean serum cortisol levels were similar, and no differences in frequency of abnormal results were noted between the two groups.CONCLUSIONS: This study shows that the combination of salmeterol and fluticasone propionate in a single inhaler is as efficacious in achieving asthma control and as well tolerated over a 28-week period as the two drugs administered individually.

scholarly journals A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma

2016 ◽  
Vol 49 (1) ◽  
pp. 1601100 ◽  
Author(s):  
Eckard Hamelmann ◽  
Jonathan A. Bernstein ◽  
Mark Vandewalker ◽  
Petra Moroni-Zentgraf ◽  
Daniela Verri ◽  
...  
Keyword(s):  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Controlled Trial ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Double Blind ◽  
Once Daily ◽  
Symptomatic Asthma ◽  
Baseline Response ◽  
Randomised Controlled

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.

scholarly journals Effects of a Short Course of Inhaled Corticosteroids in Noneosinophilic Asthmatic Subjects

2011 ◽  
Vol 18 (5) ◽  
pp. 278-282 ◽  
Author(s):  
Catherine Lemière ◽  
Caroline Tremblay ◽  
Mark FitzGerald ◽  
Shawn D Aaron ◽  
Richard Leigh ◽  
...  
Keyword(s):  
Placebo Group ◽  
Fluticasone Propionate ◽  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Poor Response ◽  
Treated Group ◽  
Forced Expiratory Volume ◽  
Open Label ◽  
Double Blind ◽  
Asthma Control Questionnaire

BACKGROUND: Noneosinophilic asthma has been regarded as a distinct phenotype characterized by a poor response to inhaled corticosteroids (ICS).OBJECTIVE: To determine whether noneosinophilic, steroid-naive asthmatic subjects show an improvement in asthma control, asthma symptoms and spirometry after four weeks of treatment with ICS, and whether they further benefit from the addition of a long-acting beta-2 agonists to ICS.METHODS: A randomized, double-blind, placebo-controlled, multicentre study comparing the efficacy of placebo versus inhaled fluticasone propionate 250 μg twice daily for four weeks in mildly uncontrolled, steroid-naive asthmatic subjects with a sputum eosinophil count ≤2%. This was followed by an open-label, four-week treatment period with fluticasone propionate 250 μg/salmeterol 50 μg, twice daily for all subjects.RESULTS: After four weeks of double-blind treatment, there was a statistically significant and clinically relevant improvement in the mean (± SD) Asthma Control Questionnaire score in the ICS-treated group (n=6) (decrease of 1.0±0.5) compared with the placebo group (n=6) (decrease of 0.09±0.4) (P=0.008). Forced expiratory volume in 1 s declined in the placebo group (−0.2±0.2 L) and did not change in the ICS group (0.04±0.1 L) after four weeks of treatment (P=0.02). The open-label treatment with fluticasone propionate 250 μg/salmeterol 50 μg did not produce additional improvements in those who were previously treated for four weeks with inhaled fluticasone alone.CONCLUSION: A clinically important and statistically significant response to ICS was observed in mildly uncontrolled noneosinophilic asthmatic subjects.

scholarly journals Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
François Maltais ◽  
Leif Bjermer ◽  
Edward M. Kerwin ◽  
Paul W. Jones ◽  
Michael L. Watkins ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Inhaled Corticosteroids ◽  
Randomised Trial ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Short Term ◽  
Double Blind ◽  
Once Daily ◽  
Clinically Important Deterioration ◽  
Exacerbation Risk

Abstract Background Prospective evidence is lacking regarding incremental benefits of long-acting dual- versus mono-bronchodilation in improving symptoms and preventing short-term disease worsening/treatment failure in low exacerbation risk patients with chronic obstructive pulmonary disease (COPD) not receiving inhaled corticosteroids. Methods The 24-week, double-blind, double-dummy, parallel-group Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised patients at low exacerbation risk not receiving inhaled corticosteroids, to umeclidinium/vilanterol 62.5/25 μg once-daily, umeclidinium 62.5 μg once-daily or salmeterol 50 μg twice-daily. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at Week 24. The study was also powered for the secondary endpoint of Transition Dyspnoea Index at Week 24. Other efficacy assessments included spirometry, symptoms, heath status and short-term disease worsening measured by the composite endpoint of clinically important deterioration using three definitions. Results Change from baseline in trough FEV1 at Week 24 was 66 mL (95% confidence interval [CI]: 43, 89) and 141 mL (95% CI: 118, 164) greater with umeclidinium/vilanterol versus umeclidinium and salmeterol, respectively (both p < 0.001). Umeclidinium/vilanterol demonstrated consistent improvements in Transition Dyspnoea Index versus both monotherapies at Week 24 (vs umeclidinium: 0.37 [95% CI: 0.06, 0.68], p = 0.018; vs salmeterol: 0.45 [95% CI: 0.15, 0.76], p = 0.004) and all other symptom measures at all time points. Regardless of the clinically important deterioration definition considered, umeclidinium/vilanterol significantly reduced the risk of a first clinically important deterioration compared with umeclidinium (by 16–25% [p < 0.01]) and salmeterol (by 26–41% [p < 0.001]). Safety profiles were similar between treatments. Conclusions Umeclidinium/vilanterol consistently provides early and sustained improvements in lung function and symptoms and reduces the risk of deterioration/treatment failure versus umeclidinium or salmeterol in symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids. These findings suggest a potential for early use of dual bronchodilators to help optimise therapy in this patient group.

scholarly journals Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
James F. Donohue ◽  
Edward Kerwin ◽  
Sanjay Sethi ◽  
Brett Haumann ◽  
Srikanth Pendyala ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Health Outcomes ◽  
Pulmonary Disease ◽  
Inhaled Corticosteroids ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Open Label ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Long Acting

Abstract Background Revefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Although shorter duration studies have documented the efficacy of revefenacin in COPD, longer-term efficacy has not been described. In a recent 52-week safety trial, revefenacin was well tolerated and had a favorable benefit-risk profile. Here we report exploratory efficacy and health outcomes in patients receiving revefenacin 175 μg or 88 μg daily during the 52-week trial. Methods In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 175 μg or 88 μg in a double-blind manner, or open-label active control tiotropium. Results Over the 52-week treatment period, both doses of revefenacin, as well as tiotropium, elicited significant (all p < 0.0003) improvements from baseline in trough forced expiratory volume in 1 s (FEV1). The trough FEV1 profile (least squares mean change from baseline) for revefenacin 175 μg ranged from 52.3–124.3 mL and the trough FEV1 profile for tiotropium ranged from 79.7–112.8 mL. In subgroup comparisons, the effect of revefenacin on trough FEV1 was comparable in patients taking concomitant long-acting β-agonists, with or without inhaled corticosteroids, with patients who were not taking these medications. There were statistically significant (p < 0.05) improvements in all measured health status outcomes (evaluated using St. George’s Respiratory Questionnaire, COPD Assessment Test, Clinical COPD Questionnaire and Baseline and Transition Dyspnea Index) from 3 months onward, in all treatment arms. Conclusions Significant sustained improvements from baseline in trough FEV1 and respiratory health outcomes were demonstrated for 175-μg revefenacin over 52 weeks, further supporting its use as a once-daily bronchodilator for the nebulized treatment of patients with COPD. Trial registration NCT02518139; Registered 5 August 2015.

scholarly journals Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients

2019 ◽  
Vol 53 (6) ◽  
pp. 1801824 ◽  
Author(s):  
Christian Vogelberg ◽  
Stanley J. Szefler ◽  
Elianne J.L.E. Vrijlandt ◽  
Attilio L. Boner ◽  
Michael Engel ◽  
...  
Keyword(s):  
Unmet Need ◽  
Comprehensive Analysis ◽  
Double Blind ◽  
Once Daily ◽  
Safety Database ◽  
Treatment Groups ◽  
Asthma Symptoms ◽  
Paediatric Patients ◽  
Asthma Patients ◽  
Symptomatic Asthma

There remains an unmet need for effective, well-tolerated therapeutic options in paediatric patients with not fully controlled asthma, for whom safety is of paramount importance.Data were pooled from five randomised, double-blind, placebo-controlled studies evaluating tiotropium 5 or 2.5 µg versus placebo add-on therapy in patients with symptomatic asthma aged 1–17 years. Analysis included adverse events (AEs) and serious AEs (SAEs) reported throughout and for 30 days following treatment.Of 1691 patients treated, 1119 received tiotropium. Reporting of AEs was low and comparable across all groups: tiotropium 5 µg (51%), tiotropium 2.5 µg (51%) and placebo (54%). Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex. The number of AEs related to asthma symptoms and exacerbations was lower with tiotropium (5 µg) than with placebo, particularly during the seasonal peaks of these AEs.This comprehensive analysis of a large safety database allowed subgroup analyses that are often impractical with individual trials and provides further support for the safety of once-daily tiotropium Respimat add-on therapy in paediatric patients with symptomatic asthma.

Bronchiolitis als mögliche unerwünschte Wirkung von Immuncheckpoint-Inhibitoren

2020 ◽  
Vol 8 (3) ◽  
pp. 152-153
Author(s):  
Nicolas Carlos Kahn
Keyword(s):  
Inhaled Corticosteroids ◽  
Respiratory Infections ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Airway Disease ◽  
Forced Expiratory Volume ◽  
Functional Improvement ◽  
High Dose ◽  
Double Blind ◽  
Dose Prednisone

Immune checkpoint inhibitors (ICIs) have been shown to improve overall and progression-free survival in various cancers but have been associated with various immune-related adverse events (IRAEs), including interstitial lung disease, especially organizing pneumonia. We report 2 cases of isolated severe airway disease attributable to ICIs, a rarely reported pattern of lung toxicity. The first patient received nivolumab with or without ipilimumab in a randomized double-blind trial for locoregional metastatic melanoma. The second patient was treated with nivolumab for lung adenocarcinoma. An IRAE was suspected in both cases due to a temporal relationship between ICI initiation and symptom onset. ICIs were stopped, and high-dose prednisone, inhaled corticosteroids, and bronchodilators were administered, allowing a rapid clinical and functional improvement in Patient 1. In Patient 2, despite prolonged high-dose prednisone, only a stabilization of forced expiratory volume in 1 s could be achieved, and the disease course was complicated by respiratory infections resulting in further loss of lung function. The patient died 1 year later due to progression of metastatic disease. These 2 cases suggest that pulmonary IRAEs secondary to ICIs may present as isolated bronchitis or bronchiolitis, with variable outcomes following ICI withdrawal and systemic corticosteroids.

scholarly journals Nebulised budesonide using a novel device in patients with oral steroid-dependent asthma

2014 ◽  
Vol 45 (5) ◽  
pp. 1273-1282 ◽  
Author(s):  
Claus Vogelmeier ◽  
Peter Kardos ◽  
Thomas Hofmann ◽  
Sebastian Canisius ◽  
Gerhard Scheuch ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Forced Expiratory Volume ◽  
Oral Steroid ◽  
Open Label ◽  
Double Blind ◽  
Novel Device ◽  
Steroid Dependent ◽  
Global Initiative For Asthma ◽  
Asthma Patients ◽  
Global Initiative

This phase 2/3 randomised, parallel-group, placebo-controlled trial investigated oral corticosteroid (OCS)-sparing efficacy, safety and tolerability of nebulised budesonide (Bud) administered with a novel computer-controlled, compressor-driven inhalation system (AKITA) as add-on therapy to Global Initiative for Asthma step 5.Patients (18–65 years) with OCS-dependent asthma were randomised (2:1:1:1) to receive 18-week, twice-daily, double-blind treatment with AKITA inhaled corticosteroid (AICS)-Bud 1 mg, AICS-Bud 0.5 mg, AICS-placebo or open-label Bud 1 mg administered by conventional nebuliser (CN-Bud). OCS doses were tapered until week 14.199 patients started treatment. More AICS-Bud 1 mg (80.0%) than placebo-treated (62.5%) patients had daily OCS doses reduced ≥50%, with clinical stability to week 18 (one-sided p=0.02; treatment difference: 17.5% (95% CI 0.1–34.9%), two-sided p=0.04). Mean±sdforced expiratory volume in 1 s improved (from baseline to week 18) for AICS-Bud 1 mg (239±460 mL, p<0.001) and AICS-Bud 0.5 mg (126±345 mL, p=0.01) but not placebo (93±419 mL, p=0.36) or CN-Bud (137±459 mL, p=0.18). Fewer AICS-Bud 1 mg-treated patients experienced asthma exacerbations (7.5%) compared with placebo (17.5%) or CN-Bud (22.5%). All treatments were well tolerated.Budesonide applied with AKITA allowed significant meaningful OCS reduction in OCS-dependent asthma patients while improving pulmonary function and maintaining exacerbation control.

scholarly journals Efficacy of indacaterol/glycopyrronium versus salmeterol/fluticasone in current and ex-smokers: a pooled analysis of IGNITE trials

2020 ◽  
pp. 00816-2020
Author(s):  
David M.G. Halpin ◽  
Claus F. Vogelmeier ◽  
Karen Mezzi ◽  
Pritam Gupta ◽  
Konstantinos Kostikas ◽  
...  
Keyword(s):  
Rescue Medication ◽  
Inhaled Corticosteroids ◽  
Smoking Status ◽  
Medication Use ◽  
Pooled Analysis ◽  
Forced Expiratory Volume ◽  
Limited Information ◽  
Asthmatic Patients ◽  
St George's Respiratory Questionnaire ◽  
The Difference

Inhaled corticosteroids have proven to be less effective in smoking asthmatic patients; however, there is limited information on the efficacy of inhaled corticosteroid-containing regimens in COPD patients who continue smoking. We evaluate the differential efficacy of once-daily indacaterol/glycopyrronium 110/50 µg compared with twice-daily salmeterol/fluticasone 50/500 µg in current smokers and ex-smokers, with COPD.A pooled analysis of data from ILLUMINATE, LANTERN and FLAME studies, was conducted to assess the efficacy of indacaterol/glycopyrronium compared with salmeterol/fluticasone in current smokers and ex-smokers, with COPD. Efficacy was assessed in terms of improvements in trough forced expiratory volume in 1 s (FEV1), transition dyspnoea index (TDI) focal score, St George's Respiratory Questionnaire (SGRQ) total score, reduced rescue medication use and exacerbation prevention at 26 weeks after the start of the therapy.In total, 1769 (38%) current smokers and 2848 (62%) ex-smokers were included. Patients treated with indacaterol/glycopyrronium experienced greater improvements in trough FEV1versus salmeterol/fluticasone in both current and ex-smokers (least squares mean treatment difference, 105 mL and 78 mL, respectively). Improvements in TDI focal score, SGRQ total score and reduction in rescue medication use were also greater with indacaterol/glycopyrronium versus salmeterol/fluticasone in current and ex-smokers. Further, indacaterol/glycopyrronium reduced all exacerbations (moderate/severe) compared with salmeterol/fluticasone, irrespective of smoking status. The difference in efficacy in favour of indacaterol/glycopyrronium was more prominent in current smokers in most cases.Indacaterol/glycopyrronium demonstrated greater efficacy versus salmeterol/fluticasone and the differences were generally more prominent in current smokers suggesting smoking may reduce the effects of salmeterol/fluticasone.

scholarly journals Long-term adherence to inhaled corticosteroids and asthma control in adult-onset asthma

2021 ◽  
Vol 7 (1) ◽  
pp. 00715-2020
Author(s):  
Iida Vähätalo ◽  
Hannu Kankaanranta ◽  
Leena E. Tuomisto ◽  
Onni Niemelä ◽  
Lauri Lehtimäki ◽  
...  
Keyword(s):  
Asthma Control ◽  
Inhaled Corticosteroids ◽  
Early Recognition ◽  
Forced Expiratory Volume ◽  
Rapid Decline ◽  
Adult Onset ◽  
Lung Function Decline ◽  
Adult Asthma ◽  
Asthma Patients

BackgroundIn short-term studies, poor adherence to inhaled corticosteroids (ICS) has been associated with worse asthma control, but the association of long-term adherence and disease control remains unclear.ObjectiveTo assess the relationship between 12-year adherence to ICS and asthma control in patients with adult-onset asthma.MethodsAs part of the Seinäjoki Adult Asthma Study, 181 patients with clinically confirmed new-onset adult asthma and regular ICS medication were followed-up for 12 years. Adherence (%) to ICS was assessed individually ((µg dispensed/µg prescribed)×100) during the follow-up. Asthma control was evaluated after 12 years of treatment according to the Global Initiative for Asthma 2010 guideline.ResultsAsthma was controlled in 31% and not controlled (partly controlled or uncontrolled) in 69% of the patients. Patients with not-controlled asthma were more often male, older, nonatopic and used higher doses of ICS than those with controlled disease. The mean±sd 12-year adherence to ICS was 63±38% in patients with controlled asthma and 76±40% in patients with not-controlled disease (p=0.042). Among patients with not-controlled asthma, those with lower 12-year adherence (<80%) had more rapid decline in forced expiratory volume in 1 s (−47 mL·year−1) compared to patients with better adherence (≥80%) (−40 mL·year−1) (p=0.024). In contrast, this relationship was not seen in patients with controlled asthma.ConclusionsIn adult-onset asthma, patients with not-controlled disease showed better 12-year adherence to ICS treatment than those with controlled asthma. In not-controlled disease, adherence <80% was associated with more rapid lung function decline, underscoring the importance of early recognition of such patients in routine clinical practice.

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