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 24-h Nitrogen dioxide concentration is associated with cooking behaviors and an increase in rescue medication use in children with asthma

2017 ◽  
Vol 159 ◽  
pp. 118-123 ◽  
Author(s):  
Laura M. Paulin ◽  
D.’Ann L. Williams ◽  
Roger Peng ◽  
Gregory B. Diette ◽  
Meredith C. McCormack ◽  
...  
Keyword(s):  
Nitrogen Dioxide ◽  
Rescue Medication ◽  
Medication Use ◽  
Children With Asthma

scholarly journals New possibilities for asthma therapy in children

2018 ◽  
pp. 192-198 ◽  
Author(s):  
T. N. Surovenko ◽  
Е. F. Glushkova
Keyword(s):  
Lung Function ◽  
Asthma Control ◽  
Russian Federation ◽  
Asthma Severity ◽  
Asthma Therapy ◽  
Improve Lung Function ◽  
The Russian Federation ◽  
Asthma In Children ◽  
Long Acting ◽  
Step Therapy

This article discusses issues of clinical diagnosis and course of bronchial asthma in children. We discuss assessment of asthma severity and, accordingly, the extent of the step-by-step therapy according to updated recommendations (GINA 2018). Particular attention is paid to the possibility of improving the control of asthma with the help of the M-cholinolytic drug of long-acting tiotropium bromide, presented as a special inhalation form of tiotropium Respimat and registered in the Russian Federation for treatment of asthma in children of moderate and severe course from 6 years of age. Application tiotropium Respimat in children with insufficient control of asthma allows to improve lung function and asthma control.

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 Tiotropium bromide as adjunct therapy in children with asthma: a clinical experience

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Zainab Ridha ◽  
Marc-Antoine Bédard ◽  
Anna Smyrnova ◽  
Olivier Drouin ◽  
Aniela Pruteanu ◽  
...  
Keyword(s):  
Lung Function ◽  
Adverse Effects ◽  
Asthma Control ◽  
Severe Asthma ◽  
Clinical Experience ◽  
Tiotropium Bromide ◽  
Treatment Goals ◽  
Improve Lung Function ◽  
Adjunct Therapy ◽  
Children With Asthma

Abstract Background The Global Initiative for Asthma has only recently added tiotropium bromide as adjunct controller therapy in severe asthma (Step 4 or 5) in adults (2015) and children (2019). Although not yet approved for pediatric use by Health Canada, it has been occasionally offered by asthma specialists as a therapeutic trial in children with troublesome asthma or treatment for adverse effects. The objective of this study was to describe the indications and real-life clinical experience in initiating tiotropium in children with asthma. Methods We designed a retrospective mixed-method case series study of children aged 1–17 years who initiated tiotropium in our tertiary-care centre between 2013 and 2020. Clinical information was extracted from electronic medical records and tiotropium dispensing, from drug claims. Parents/children and physicians independently completed a questionnaire about treatment goals, perceived efficacy, safety, satisfaction, and lessons learned. Results The 34 (11 females; 23 males) children had a median (range) age of 9.1 (1.4–17.8) years. Children were primarily on Step 4 (85%) or 5 (6%) prior to tiotropium initiation, yet most (84%) did not increase their treatment step after tiotropium initiation. The physicians’ treatment goals were to improve asthma control, alleviate adverse effects of current therapy, and/or improve lung function. The most improved symptoms were coughing/moist cough, difficulty breathing, whistling breath, and bronchial secretions/mucus. Although most parents and physicians reported a significant benefit with tiotropium bromide, physicians particularly remarked, as their “lesson learned’, on the improvement in chronic symptoms in asthmatic children, particularly those with prominent moist cough and in lung function, in those with seemingly none (or incompletely) reversible obstruction as well as the ability to decrease the ICS and/or LABA dose to lessen adverse effects. A few physicians raised caution on the risk of lower adherence with an additional inhaler. Conclusion In children with severe asthma on Step 4 or 5, tiotropium bromide was primarily used as substitute, rather than additional, adjunct therapy to improve asthma control, alleviate adverse effects, and/or to improve lung function. The latter two indications, combined with its perceived effectiveness in children with prominent moist cough, also suggest additional indications of tiotropium to be formally explored.

scholarly journals Assessment of asthma control and lung function in asthmatic children in Sokoto, North Western Nigeria

2021 ◽  
Vol 0 ◽  
pp. 1-6
Author(s):  
Fatima Abubakar Ishaq ◽  
Bilkisu Ilah Garba ◽  
Nma Mohammad Jiya ◽  
Ahmed Hamidu
Keyword(s):  
Lung Function ◽  
Asthma Control ◽  
Cross Sectional Study ◽  
University Teaching ◽  
Cross Sectional ◽  
Asthmatic Children ◽  
Children With Asthma ◽  
Global Initiative ◽  
Gina Guidelines ◽  
Study Participants

Objectives: This study aimed at assessing asthma control using Global Initiative for Asthma (GINA) asthma assessment, and determining its relationship with lung function parameters among asthmatic children in Usmanu Danfodiyo University Teaching hospital, Sokoto. Materials and Methods: This was a cross-sectional study among 60 children with asthma diagnosed based on GINA guidelines. It was conducted over a period of 4 months. The GINA asthma control assessment was administered to assess asthma control. Lung function was done using a portable spirometer. Results: Males accounted for 58.3% of the study population with M: F of 1.4:1 and median age of 9.47 years, with majority from urban domicile (91.7%). Well-controlled asthma accounted for 50.0% while 35.0% had partly controlled asthma and 15.0% had poorly controlled asthma. The median FEV1/FVC among the study participants was 0.856 (IQR: 0.170). There was no relationship between asthma control and LF parameters (FEV1: r = 0.044, P = 0.736, FVC: r = 0.010, P = 0.941, FEV1/FVC: r = 0.122, P = 0.352, and PEFR: r = 0.015, P = 0.911). Conclusion: Majority of the study participants had well-controlled asthma and no relationship was found between asthma control and lung function. Thus, serial monitoring of LF in addition to uniformly agreed standardized assessment of asthma control is required to objectively evaluate asthma control in children.

scholarly journals Vitamin D supplementation, lung function, and asthma control in children with asthma and low vitamin D levels

2021 ◽  
pp. 2100989
Author(s):  
Yueh-Ying Han ◽  
Erick Forno ◽  
Leonard B. Bacharier ◽  
Wanda Phipatanakul ◽  
Theresa W. Guilbert ◽  
...  
Keyword(s):  
Vitamin D ◽  
Lung Function ◽  
Asthma Control ◽  
Vitamin D Supplementation ◽  
Vitamin D Levels ◽  
Children With Asthma
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