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A Phase II, randomised, double-blind, placebo-controlled, parallel-group, dose-ranging, efficacy and safety trial of BI 730357 given for 12 weeks in patients with active psoriatic arthritis

开始日期2022-04-04

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2020-12-01·Pulmonary Therapy

Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis

Article

作者: Goldstein, Stanley ; Hamelmann, Eckard H ; Moroni-Zentgraf, Petra M ; Szefler, Stanley J ; Sigmund, Ralf ; Given, John ; Engel, Michael ; Bensch, George W ; Vogelberg, Christian ; Jugovic, Branko

AbstractIntroductionIn pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV1) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEF25–75%) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEF25–75% with FEV1 as an endpoint to assess bronchodilator responsiveness in children with asthma.MethodsChange from baseline in trough FEF25–75% and trough FEV1 following treatment with either tiotropium (5 µg or 2.5 µg) or placebo Respimat® was analyzed in four phase III trials in children (aged 6–11 years) and adolescents (aged 12–17 years) with symptomatic moderate (VivaTinA-asthma® and PensieTinA-asthma®) and mild (CanoTinA-asthma® and RubaTinA-asthma®) asthma. Data from all treatment arms were pooled and correlations between FEF25–75% and FEV1 were calculated and analyzed.ResultsA total of 1590 patients were included in the analysis. Tiotropium Respimat® consistently improved FEF25–75% and FEV1 versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEF25–75% response with tiotropium versus placebo were largely more pronounced than improvements in FEV1. Statistical assessment of the correlation of FEV1 and FEF25–75% showed moderate-to-high correlations (Pearson’s correlation coefficients 0.73–0.80).ConclusionsIn pediatric patients, FEF25–75% may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV1 and should be evaluated as an additional lung function measurement.

2020-09-01·The Journal of Allergy and Clinical Immunology: In Practice1区 · 医学

Tiotropium Respimat Efficacy and Safety in Asthma: Relationship to Age

1区 · 医学

Article

作者: Zaremba-Pechmann, Liliana ; Moroni-Zentgraf, Petra ; Kerstjens, Huib A M ; Bleecker, Eugene R ; Doherty, Dennis E

BACKGROUNDData are limited on the differential response to long-acting bronchodilators in older versus younger adults with asthma.OBJECTIVETo determine whether the response to tiotropium Respimat differed in older versus younger patients with asthma.METHODSPost hoc analyses of 4 randomized, double-blind, placebo-controlled studies in adults with asthma were carried out. Two studies compared tiotropium Respimat 5 μg once daily with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β₂-agonist (ie, severe asthma). The other 2 evaluated tiotropium Respimat 2.5 or 5 μg once daily, salmeterol 50 μg twice daily, or placebo, all added to medium-dose ICS (moderate asthma). Data were analyzed in 2 pools: (1) severe and (2) moderate asthma. Efficacy end points: trough and peak FEV₁; trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage, all at week 24. One set of analyses was performed with age as a continuous covariate; the second was conducted in categories less than 40, 40 to 60, and more than 60 years, with treatment-by-age subgroup interaction P values obtained. Safety was analyzed in age categories.RESULTSAcross the age categories, treatment-by-age subgroup interaction P values for trough FEV₁ were .13 and .77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the 2 continuum analyses. The other end points (including safety) were also not impacted by age.CONCLUSIONSOnce-daily tiotropium Respimat add-on to ICS or ICS/long-acting β₂-agonist therapy was effective and well tolerated in patients with asthma independent of age.

2020-06-01·Pulmonary Therapy

Comparative Responses in Lung Function Measurements with Tiotropium in Adolescents and Adults, and Across Asthma Severities: A Post Hoc Analysis

Article

作者: Frith, Peter A ; van Hecke, Benjamin ; Moroni-Zentgraf, Petra M ; Halpin, David M G ; Szefler, Stanley J ; Unseld, Anna ; Hamelmann, Eckard H ; Kerstjens, Huib A M

INTRODUCTIONAirway obstruction is usually assessed by measuring forced expiratory volume in 1 s (FEV₁), forced vital capacity (FVC) and peak expiratory flow (PEF). This post hoc study investigated comparative responses of lung function measurements in adults and adolescents (full analysis set, N = 3873) following treatment with tiotropium Respimat^®.METHODSLung function outcomes were analysed from five phase III trials in adults (≥ 18 years) with symptomatic severe, moderate and mild asthma (PrimoTinA-asthma^®, MezzoTinA-asthma^® and GraziaTinA-asthma^®, respectively), and one phase III trial in adolescents (12-17 years) with symptomatic moderate asthma (RubaTinA-asthma^®). Changes from baseline versus placebo in FEV₁, FVC, PEF and FEV₁/FVC ratio with tiotropium 5 µg or 2.5 µg added to at least stable inhaled corticosteroids at week 24 (week 12 in GraziaTinA-asthma) were analysed.RESULTSAll lung function measures improved in all studies with tiotropium 5 µg (mean change from baseline versus placebo), including peak FEV₁ (110-185 mL), peak FVC (57-95 mL) and morning PEF (15.8-25.6 L/min). Changes in adolescents were smaller than those in adults, and were statistically significant primarily for FEV₁ and PEF, but not for FVC.CONCLUSIONConsistent improvements were seen across all lung function measures with the addition of tiotropium to other asthma treatments in adults across all severities, whereas the improvements with tiotropium in adolescents primarily impacted measures of flow rather than lung volume. This may reflect less pronounced airway remodelling and air trapping in adolescents with asthma versus adults.

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