Safety of ciclesonide in children with asthma: A review of randomized controlled trials.
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ABSTRACT:
SUBMITTER: Blaiss M
PROVIDER: S-EPMC8654382 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: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.
| S-EPMC8654387 | biostudies-literature
Project description:Background: Asthma and obesity are major public health problems, affecting hundreds of millions of people worldwide. Obesity is associated with increased asthma risk and severity, and lower asthma-related quality of life. Objective: In this systematic review, we aimed to evaluate whether weight loss in subjects with obesity and asthma leads to improvement in asthma-related outcomes. Data Sources and Extraction: We searched PubMed and Google Scholar for all studies in English published January 2000-December 2018. Studies were included if they were randomized, controlled clinical trials (RCTs) for overweight/obese children or adults with asthma, with sufficient data to assess outcomes and study quality. Non-randomized and non-controlled studies were excluded, as well as those in subjects without overweight/obesity, or with non-asthmatic controls. Synthesis: We identified four RCTs involving children (total n = 246) and six involving adults (n = 502). All interventions were designed for weight loss and varied from dietary restrictions to multifactorial interventions with exercise training and cognitive behavioral therapy; the duration of intervention ranged from 8 weeks to 18 months. All RCTs reported successful improvements in weight or body mass index (-0.14 standard deviation scores to -15.9% BMI reduction in children, 1.8%-14.5% weight loss in adults). RCTs generally reported improvements in asthma-related quality of life and, to some degree, asthma control. RCTs involving adults also reported improvements in lung function (FEV1, FVC, TLC), while RCTs in children showed less consistent results. Conclusions: These findings suggest that weight loss in subjects with obesity and asthma may improve asthma outcomes. However, there was wide variability in populations studied, baseline and post-intervention assessments, follow-up length, outcome definition and reporting, and statistical approaches, which hindered the ability to compare studies, perform a pooled analysis, or assess generalizability. Primary Source of Funding: U.S. National Institutes of Health (NIH).
| S-EPMC6491056 | biostudies-literature
Project description:BackgroundAsthma is a common chronic respiratory disease in children. Alongside pharmacological interventions, inspiratory muscle training (IMT) emerges as a complementary therapeutic approach for asthma management. However, the extent of its efficacy in pediatric populations remains uncertain when compared to its benefits in adults. This systematic review aims to evaluate the effectiveness of IMT with threshold loading in children with asthma.MethodsRandomized controlled trials (RCTs) evaluating the efficacy of inspiratory muscle training in pediatric asthma patients were identified through June 2023 across various literature databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAL), Web of Science, China Knowledge Resource Integrated Database (CNKI), Wei Pu Database, Wan Fang Database, and Chinese Biomedical Database (CBM). These trials compared inspiratory muscle training against sham inspiratory muscle training and conventional care. Eligible studies were assessed in terms of risk of bias and quality of evidence. Where feasible, data were pooled and subjected to meta-analysis, with results reported as mean differences (MDs) and 95% confidence intervals (CIs).ResultsSix trials involving 333 patients were included in the analysis. IMT demonstrated significant improvements in maximum inspiratory pressure (MIP) (MD 25.36, 95% CI 2.47-48.26, P = 0.03), maximum expiratory pressure (MEP) (MD 14.72, 95% CI 4.21-25.24, P = 0.006), forced vital capacity in percent predicted values [FVC(% pred)] (MD 3.90, 95% CI 1.86-5.93, P = 0.0002), forced expiratory volume in the first second in percent predicted values [FEV1(% pred)] (MD 4.96, 95% CI 2.60-7.32, P < 0.0001), ratio of forced expiratory volume in 1 s to forced vital capacity (FEV1/FVC) (MD 4.94, 95% CI 2.66-7.21, P < 0.0001), and asthma control test (ACT) (MD = 1.86, 95% CI: 0.96-2.75, P < 0.0001).ConclusionsFindings from randomized controlled trials indicate that inspiratory muscle training enhances respiratory muscle strength and pulmonary function in pediatric asthma patients.Systematic review registrationwww.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023449918, identifier: CRD42023449918.
| S-EPMC10982517 | biostudies-literature
Project description:This systematic review evaluated the effectiveness of psychological interventions for reducing vaccination pain and related outcomes in children and adolescents.Database searches identified relevant randomized and quasi-randomized controlled trials. Data were extracted and pooled using established methods. Pain, fear, and distress were considered critically important outcomes.Twenty-two studies were included; 2 included adolescents. Findings showed no benefit of false suggestion (n=240) for pain (standardized mean difference [SMD] -0.21 [-0.47, 0.05]) or distress (SMD -0.28 [-0.59, 0.11]), or for use of repeated reassurance (n=82) for pain (SMD -0.18 [-0.92, 0.56]), fear (SMD -0.18 [-0.71, 0.36]), or distress (SMD 0.10 [-0.33, 0.54]). Verbal distraction (n=46) showed reduced distress (SMD -1.22 [-1.87, -0.58]), but not reduced pain (SMD -0.27 [-1.02, 0.47]). Similarly, video distraction (n=328) showed reduced distress (SMD -0.58 [-0.82, -0.34]), but not reduced pain (SMD -0.88 [-1.78, 0.02]) or fear (SMD 0.08 [-0.25, 0.41]). Music distraction demonstrated reduced pain when used with children (n=417) (SMD -0.45 [-0.71, -0.18]), but not with adolescents (n=118) (SMD -0.04 [-0.42, 0.34]). Breathing with a toy (n=368) showed benefit for pain (SMD -0.49 [-0.85, -0.13]), but not fear (SMD -0.60 [-1.22, 0.02]); whereas breathing without a toy (n=136) showed no benefit for pain (SMD -0.27 [-0.61, 0.07]) or fear (SMD -0.36 [-0.86, 0.15]). There was no benefit for a breathing intervention (cough) in children and adolescents (n=136) for pain (SMD -0.17 [-0.41, 0.07]).Psychological interventions with some evidence of benefit in children include: verbal distraction, video distraction, music distraction, and breathing with a toy.
| S-EPMC4900411 | biostudies-other
Project description:To systematically review and synthesize the safety and efficacy of coronavirus disease-2019 (COVID-19) vaccines in children and adolescents. PubMed, EMBASE, Web of Science, Cochrane Library databases, the International Clinical Trials Registry Platform (ICTRP), the Chinese Clinical Trials Registry (ChiCTR), and ClinicalTrials.gov website were searched to collect accessible randomized controlled trials (RCTs) about the safety and efficacy of human COVID-19 vaccines in children and adolescents until May 1, 2022. Three steps, including duplicate removal, title and abstract screening, and full-text review, were used to screen the studies. The Cochrane risk-of-bias tool for RCTs was used to assess the bias risk of the included studies. Microsoft Excel 16.57 (2021) software was used for data extraction and analysis. (PROSPERO Code No: CRD42021295422). COVID-19 vaccines were evaluated in a total of 10 950 children and adolescents in seven published studies and over 49 530 participants in 26 ongoing randomized controlled trials. Descriptive findings of the included published studies were reported stratified by vaccine type. The overall, local, and systemic adverse events following immunization (AEFIs) reported in most trials were similar between the vaccine and placebo groups. Most of the reactions reported were mild to moderate, whereas a few were severe. The common adverse events were injection-site pain, fever, headache, cough, fatigue, and muscle pain. Few clinical trials reported serious adverse events, but most of them were unrelated to vaccination. In terms of efficacy, the investigated messenger RNA (mRNA) vaccine was found to be 90.7%-100% efficacious in preventing COVID-19 among children and adolescents, revealing good efficacy profiles in this age group. Among children and adolescents, the safety of current COVID-19 vaccines is acceptable, and studies have suggested that mRNA vaccines can provide high protection against COVID-19 infection in pediatric age groups.
| S-EPMC9350282 | biostudies-literature
Project description:BackgroundInadequate pediatric asthma care has resulted in potentially avoidable unplanned hospital admissions and morbidity. A wide variety of digital technologies have been developed to monitor and support treatment adherence in children and adolescents with asthma. However, existing reviews need to be updated and expanded to provide an overview of the current state of research on these technologies and how they are being integrated into existing health care services and care pathways.ObjectiveThis study aims to provide an overview of the current research landscape and knowledge gaps regarding the use of digital technologies to support the care of children and adolescents with asthma.MethodsThis study was structured according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) and Population, Intervention, Comparator, Outcome, and Study frameworks. Five databases (PubMed, the Cochrane Central Register of Controlled Trials, Web of Science, Embase, and PsycINFO) were systematically searched for studies published in English from 2014 onward. Two reviewers independently screened the references and selected studies for inclusion based on the eligibility criteria. Data were systematically extracted per research question, which were synthesized in a descriptive analysis.ResultsA wide variety of study characteristics, including the number and age of participants, study duration, and type of digital intervention, were identified. There was mixed evidence for the effectiveness of the interventions. Of the 10 studies that evaluated treatment adherence, 7 (70%) found improvements, but the evidence was inconsistent for asthma control (6/9, 67% of studies reported improvement or maintenance, but only 1 was significantly different between groups) and health outcome variables (5/9, 56% of studies found no evidence of effectiveness). The 6 studies that examined patient perceptions and assessments of acceptability and usability generally had positive findings.ConclusionsA wide range of digital interventions are being developed and evaluated to support the monitoring and treatment adherence of children and adolescents with asthma. Meta-analyses are inhibited by the use of samples with a variety of overlapping age ranges; a theoretical framework for evaluating specific age groups would aid comparison between studies. Most studies found significant evidence for improved adherence to treatment or medications, but there was mixed evidence of the impact of the digital interventions on asthma control and other health outcomes. There are gaps in the literature relating to cost-effectiveness and integration with existing clinical care pathways. This study will be necessary to determine which digital interventions for children and young people with asthma are worth supporting and adopting in the clinical care pathways.
| S-EPMC8486994 | biostudies-literature
Project description:Chinese herbal medicine is commonly used as a treatment for benign prostatic hyperplasia (BPH), but its efficacy and safety remain to be examined. To compare the efficacy and adverse events of Chinese herbal medicine alone or used adjuvantly with Western medications for BPH. Two independent reviewers searched the major electronic databases for randomized controlled trials comparing Chinese herbal medicine, either in single or adjuvant use with Western medication, with placebo or Western medication. Relevant journals and grey literature were also hand-searched. The outcome measures included changes in urological symptoms, urodynamic measures, prostate volume and adverse events. The frequency of commonly used herbs was also identified. Out of 13 922 identified citations of publications, 31 studies were included. Eleven studies with a Jadad score ≥ 3 were selected for meta-analysis. Chinese herbal medicine was superior to Western medication in improving quality of life and reducing prostate volume. The frequency of adverse events in Chinese herbal medicine was similar to that of placebo and less than that of Western medication. The evidence is too weak to support the efficacy of Chinese herbal medicine for BPH due to the poor methodological quality and small number of trials included. The commonly used herbs identified here should provide insights for future clinical practice and research. Larger randomized controlled trials of better quality are needed to truly evaluate the efficacy of Chinese herbal medicine.
| S-EPMC3739225 | biostudies-other
Project description:Acupoint herbal patching (AHP), which involves local point stimulation with a herbal medicine patch, has long been used to treat patients with asthma in East Asian countries. However, its evidence is equivocal. This systematic review aims to summarize and critically evaluate the efficacy and safety of AHP for asthma.A literature search was conducted in PubMed, EMBASE, the Cochrane library, and the China National Knowledge Infrastructure for studies published on or before April 2014, which were randomized controlled trials (RCTs) examining AHP therapy by itself or in combination with other treatments in asthma patients. Trials needed to report pulmonary function outcomes to be included in analyses. The risk of bias of included studies was assessed using the Cochrane risk of bias assessment tool. For statistical pooling, risk ratio, mean difference (MD), or standardized MD was calculated with 95% confidence intervals (CIs) in a random-effects model.We ultimately included 16 RCTs with 1287 asthmatic patients in analyses. Treatment with AHP improved forced expiratory volume in 1?second (FEV1) by 13% (MD?=?12.99%, 95% CI 5.17%-20.81%) and asthmatic symptoms by 60% (risk ratio of unchanged or getting worse symptoms with AHP?=?0.4, 95% CI 0.27-0.58) over that observed with placebo. However, evidence is limited due to the heterogeneity and paucity of data. When added to conventional therapies, AHP significantly improved the FEV1/forced vital capacity ratio by 11.6% (95% CI 8.49%-14.79%) and reduced the risk of asthmatic symptoms by 69% (95% CI 0.16-0.58). Compared with conventional medication, AHP significantly improved FEV1 (standardized MD?=?0.46, 95% CI 0.05-0.87), but a substantial heterogeneity was detected (I?2=?53%). When added to Chinese herbal medicine, there were no additional benefits of AHP on pulmonary function or global symptom improvement. No serious adverse events were associated with AHP.Evidence for AHP efficacy is encouraging, but not conclusive, because of clinical diversity and the high risk of bias in the examined studies. Further clinical and basic research is needed to determine the role of AHP in lung function and symptom improvement in patients with asthma.
| S-EPMC4718253 | biostudies-literature
Project description:BackgroundThis systematic review evaluated the effectiveness of distraction for reducing infant distress during vaccinations in young children aged 0 to 3 years.Design/methodsDatabase searches identified relevant randomized and quasi-randomized controlled trials. Three separate clinical questions related to variants of the psychological strategy of distraction (directed video; directed toy; nondirected toy) were pursued. Distress was identified as the critical outcome to assess the benefits of distraction and extracted from relevant trials. Distress was analyzed by phase of procedure (distress preprocedure; distress acute; distress recovery; idiosyncratic phases based on some or all of the 3 aforementioned phases).ResultsTen studies were included in the review. Significant results are presented herein. For directed video distraction, moderate quality evidence suggested that distress was lowered in the treatment group standardized mean difference (SMD -0.68 lower [95% confidence interval (CI), -1.04 to -0.32]) for the acute+recovery phase as well as the preprocedure phase (SMD -0.49 lower [95% CI, -7.6 to -0.22]). For directed toy distraction, the analysis of low-quality evidence for a combined preprocedure+acute+recovery phase of distress (analysis n=81), suggested that distress was lowered in the treatment group (SMD -0.47 lower [95% CI, -0.91 to -0.02]). An effect for nondirected toy distraction was also seen, analyzing very-low-quality evidence, for the acute distress phase (n=290; SMD -0.93 lower [95% CI, -1.86 to 0.00]).ConclusionGenerally low-quality to very-low-quality evidence suggests that there may be an effect of directed (toy and video) and nondirected toy distraction for children aged 0 to 3 years, for certain phases of the vaccination.
| S-EPMC4900410 | biostudies-literature
Project description:ContextAsymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control.ObjectiveTo determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER.Design, setting, and participantsThe Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization.InterventionParticipating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157).Main outcome measuresThe primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control.ResultsThe mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for any asthma outcome. Children treated with lansoprazole reported more respiratory infections (relative risk, 1.3 [95% CI, 1.1-1.6]).ConclusionIn this trial of children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, compared with placebo, improved neither symptoms nor lung function but was associated with increased adverse events.Trial registrationclinicaltrials.gov Identifier: NCT00442013.
| S-EPMC4153372 | biostudies-literature