Zileuton Provides Significant Improvement in Asthma Symptoms and β-agonist and Rescue Medication Use Compared to Placebo in Asthma Patients with Reduced or Low Lung Function

2006 ◽  
Vol 117 (2) ◽  
pp. S156-S157
Author(s):  
R.A. Nathan ◽  
B.M. Prenner ◽  
J.A. Bernstein ◽  
K. Walton-Bowen
Keyword(s):  
Lung Function ◽  
Rescue Medication ◽  
Medication Use ◽  
Asthma Symptoms ◽  
Asthma Patients

Review of efficacy of ciclesonide for the treatment of asthma in children

2021 ◽  
Vol 42 (6) ◽  
pp. 461-470 ◽  
Author(s):  
Michael Blaiss ◽  
William Berger ◽  
Bradley Chipps ◽  
Vivian Hernandez-Trujillo ◽  
Wanda Phipatanakul ◽  
...  
Keyword(s):  
Lung Function ◽  
Asthma Control ◽  
Active Control ◽  
Rescue Medication ◽  
Medication Use ◽  
Asthma Symptoms ◽  
End Point ◽  
Children With Asthma ◽  
Asthma In Children ◽  
Expiratory Flow

Background: Ciclesonide (CIC) is an inhaled corticosteroid (ICS) approved for the maintenance treatment of asthma in patients ages ≥ 12 years. The prodrug aspect of CIC is associated with a safety profile that may make it ideal for children. Objective: The objective was to summarize efficacy results from the eight phase III, randomized, double-blind, controlled trials in children with asthma conducted during CIC clinical development. Methods: Four trials compared CIC 40, 80, or 160 µg/day with placebo. Two trials compared CIC 160 µg/day with fluticasone propionate 200 µg/day, one trial compared CIC 80 or 160 µg/day with fluticasone 200 µg/day, and one trial compared CIC 160 µg/day with budesonide 400 µg/day. Results: The primary end point was met by at least two CIC doses versus placebo in the trials in which the primary end point was the change from baseline in lung function outcome (forced expiratory volume in 1 second [FEV1] % predicted or morning peak expiratory flow [PEF]). A trial that compared CIC with placebo did not meet the primary end point of superiority in time-to-first severe wheeze exacerbation or lack of improvement. The primary end point of noninferiority to the active control (fluticasone or budesonide) in the change from baseline in a lung function outcome (FEV1, morning PEF, evening PEF) was met with the CIC 160-µg dose in all active control trials. CIC generally demonstrated statistically significant improvements in forced expiratory flow at 25%‐75% of forced vital capacity, asthma symptoms, rescue medication use, and asthma control when compared with placebo and noninferiority for these outcomes compared with fluticasone or budesonide. Conclusion: In children with asthma, once-daily CIC significantly improved large and small airway function, asthma symptoms, and asthma control, and reduced rescue medication use compared with placebo. CIC was comparable with other ICS used to treat asthma in children, which demonstrated its worth for the pediatric population.

scholarly journals Efficacy of umeclidinium/vilanterol according to the degree of reversibility of airflow limitation at screening: a post hoc analysis of the EMAX trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Claus F. Vogelmeier ◽  
Paul W. Jones ◽  
Edward M. Kerwin ◽  
Isabelle H. Boucot ◽  
François Maltais ◽  
...  
Keyword(s):  
Lung Function ◽  
Rescue Medication ◽  
Inhaled Corticosteroids ◽  
Full Range ◽  
Medication Use ◽  
Airflow Limitation ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Once Daily ◽  
Post Hoc

Abstract Background In patients with chronic obstructive pulmonary disease (COPD), the relationship between short-term bronchodilator reversibility and longer-term response to bronchodilators is unclear. Here, we investigated whether the efficacy of long-acting bronchodilators is associated with reversibility of airflow limitation in patients with COPD with a low exacerbation risk not receiving inhaled corticosteroids. Methods The double-blind, double-dummy EMAX trial randomised patients to umeclidinium/vilanterol 62.5/25 µg once daily, umeclidinium 62.5 µg once daily, or salmeterol 50 µg twice daily. Bronchodilator reversibility to salbutamol was measured once at screening and defined as an increase in forced expiratory volume in 1 s (FEV1) of ≥ 12% and ≥ 200 mL 10−30 min post salbutamol. Post hoc, fractional polynomial (FP) modelling was conducted using the degree of reversibility (mL) at screening as a continuous variable to investigate its relationship to mean change from baseline in trough FEV1 and self-administered computerised-Transition Dyspnoea Index (SAC-TDI) at Week 24, Evaluating Respiratory Symptoms-COPD (E-RS) at Weeks 21–24, and rescue medication use (puffs/day) over Weeks 1–24. Analyses were conducted across the full range of reversibility (−850–896 mL); however, results are presented for the range −100–400 mL because there were few participants with values outside this range. Results The mean (standard deviation) reversibility was 130 mL (156) and the median was 113 mL; 625/2425 (26%) patients were reversible. There was a trend towards greater improvements in trough FEV1, SAC-TDI, E-RS and rescue medication use with umeclidinium/vilanterol with higher reversibility. Improvements in trough FEV1 and reductions in rescue medication use were greater with umeclidinium/vilanterol compared with either monotherapy across the range of reversibility. Greater improvements in SAC-TDI and E-RS total scores were observed with umeclidinium/vilanterol versus monotherapy in the middle of the reversibility range. Conclusions FP analyses suggest that patients with higher levels of reversibility have greater improvements in lung function and symptoms in response to bronchodilators. Improvements in lung function and rescue medication use were greater with umeclidinium/vilanterol versus monotherapy across the full range of reversibility, suggesting that the dual bronchodilator umeclidinium/vilanterol may be an appropriate treatment for patients with symptomatic COPD, regardless of their level of reversibility.

scholarly journals Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma

2019 ◽  
Vol 6 (1) ◽  
pp. e000406
Author(s):  
Rebecca N Bauer ◽  
Xiaoying Yang ◽  
Tracy L Staton ◽  
Julie Olsson ◽  
Cecile T J Holweg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Seasonal Variability ◽  
Rescue Medication ◽  
Medication Use ◽  
Life Questionnaire ◽  
Uncontrolled Asthma ◽  
Quality Of Life Questionnaire ◽  
Asthma Exacerbations

IntroductionAsthma exacerbations spike in the spring and autumn months, yet the seasonal variation of asthma symptoms and lung function is poorly studied.MethodsSeasonal variation of lung function, rescue medication use and patient-reported symptoms was evaluated by posthoc analyses of the Phase III lebrikizumab (anti-IL-13) LAVOLTA I and II studies in 2148 subjects with uncontrolled asthma. Lung function measurements (prebronchodilator FEV1, forced vital capacity (FVC) and peak expiratory flow (PEF)), rescue medication use and Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) were measured every 4 weeks over 52 weeks. By-month estimates normalised by hemispheric season were based on mixed-effect models with repeated measures (MMRM), adjusted by study stratification factors as covariates when appropriate. The dependency of clinical outcomes with seasonal variability was assessed by employing linear contrasts comparing hemisphere normalised December versus July group means from an MMRM regression and presented as the difference in means (adjusted 95% CI).ResultsFEV1, FVC and PEF, rescue medication use and AQLQ(S) progressively worsened towards winter, unlike spring and autumn surges in asthma exacerbations. The December versus July mean differences were: (1) PEF=−6.5 (–8.7 to –4.2) L/min, 2) prebronchodilator FEV1=−42 (–57 to –27) mL, (3) FVC=−41 (−59 to –23) mL and (4) AQLQ(S)=−0.15 (–0.19 to –0.1) units. Among AQLQ questions, discomfort or distress related to cough was most variable with respect to season (−0.33 (−0.42 to –0.24) units).DiscussionInterpretation of interventional studies biased by seasonal exposures may be confounded by seasonal variability.Trials registration numbersNCT01867125 and NCT01868061.

scholarly journals Classification of non-acute bronchial asthma according to allergy and eosinophil characteristics: a retrospective study

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Yi Jiang ◽  
Ruoli An ◽  
Li Cheng ◽  
Qianru Yue ◽  
Hanwei Zhang ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Lung Function ◽  
Allergic Asthma ◽  
Asthma Management ◽  
Effective Management ◽  
Sputum Cytology ◽  
Eosinophilic Asthma ◽  
Asthma Patients ◽  
Medical University

Abstract Background Investigating the endotypes of the different asthma phenotypes would help disease monitoring, prognosis determination, and improving asthma management standardization. This study aimed to classify asthma into four endotypes according to the allergic and eosinophilic characteristics and explore the phenotypes (clinical characteristics, pulmonary functions, and fractional expired nitric oxide (FeNO)) of each endotype. Methods This retrospective study included non-acute asthma patients treated at the First Hospital of Shanxi Medical University (05/2016–01/2018). The patients were classified into the eosinophilic allergic, eosinophilic non-allergic, non-eosinophilic allergic, and non-eosinophilic non-allergic asthma endotypes. Serum sIgE, lung function, FeNO, and induced sputum cytology were tested and compared among groups. Results Of the 171 included patients, 22 had eosinophilic allergic asthma, 17 had eosinophilic non-allergic asthma, 66 had non-eosinophilic allergic asthma, and 66 had non-eosinophilic non-allergic asthma. Lung function measurements (FEV1%, FEF25%, FEF50%, FEF75%, and FEF25–75%) showed that airway dysfunction was worse in eosinophilic non-allergic asthma than in the other three endotypes (all P < 0.001). In allergic asthma patients, eosinophilic asthma had worse airway dysfunction than non-eosinophilic asthma (all P < 0.05). Similar results were found in non-allergic asthma (all P < 0.01). The FeNO levels in eosinophilic allergic asthma were higher than in eosinophilic non-allergic and non-eosinophilic non-allergic asthma (both P = 0.001). Conclusions FeNO can objectively reflect eosinophilic airway inflammation in asthma. Endotypic classification of asthma patients regarding the allergic and eosinophilic characteristics is conducive to the effective management of patients with asthma.

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