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Zataria multiflora extract influenced asthmatic patients by improving respiratory symptoms, pulmonary function tests and lung inflammation.
Alavinezhad, A, Ghorani, V, Rajabi, O, Boskabady, MH
Journal of ethnopharmacology. 2022;:114888
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Anti-inflammatory and anti-oxidant effects of Zataria multiflora Boiss (Z. multiflora) were reported in previous studies which is using in traditional and modern medicine. This plant is traditional used as an anti-tussive agent and for the management of respiratory disorders. AIM OF THE STUDY The preventive effect of the extract of leaves and stems of Z. multiflora on respiratory symptoms, pulmonary function tests, hematological indices, high sensitivity C-reactive protein (hs-CRP), level of interleukin-10 (IL-10) in the serum and supernatant of cultured peripheral blood mononuclear cells (PBMC) and gene expression of IL-10 in these cells in asthmatic patients was studied. MATERIALS AND METHODS 36 asthmatic patients in three groups (randomly divided) of placebo group (P), two groups treated with 5 and 10 mg/kg/day doses of Z. multiflora (Z5 and Z10) for two months completed the study. Drugs were administered double-blindly and different variables were assessed before and after (one and two months) starting treatment including respiratory symptoms, pulmonary function tests (PFT), hematological indices, hs-CRP, serum and supernatant levels as well as gene expression of IL-10. RESULTS Two months treatment with Z5 and Z10 led to significant reduction of respiratory symptoms (p < 0.05 to p < 0.001). Pulmonary function test values in treated groups were also significantly increased two months after starting treatment (p < 0.05 to p < 0.001). Total WBC, monocytes and eosinophils were also decreased in treated groups with the extract at the end of study period (p < 0.05 to p < 0.01). Hemoglobin and hematocrit in Z10 treated group (p < 0.05 and p < 0.01, respectively) and mean corpuscular volume (MCV) in both treated groups (p < 0.05 to p < 0.01) were significantly reduced. In addition, the level of hs-CRP in both treated groups was significantly reduced after two months (p < 0.05 to p < 0.01). IL-10 concentration in Z10 treated group in supernatant of PBMC was also significantly enhanced (p < 0.01). All comparisons were made compared to the baseline (beginning of the treatment) values. CONCLUSION Z. multiflora improved respiratory symptoms and increased pulmonary function tests in asthmatic patients. In addition, the plant was effective in decrement of inflammatory cells and hs-CRP as well as enhanced IL-10. Therefore, the plant showed possible preventive therapeutic effect on asthma.
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Limosilactobacillus reuteri DSM-17938 for preventing cough in adults with mild allergic asthma: A double-blind randomized placebo-controlled cross-over study.
Satia, I, Cusack, R, Stevens, C, Schlatman, A, Wattie, J, Mian, F, Killian, KJ, O'Byrne, PM, Bienenstock, J, Forsythe, P, et al
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology. 2021;(9):1133-1143
Abstract
BACKGROUND Cough is a common troublesome symptom in asthma which is neuronally mediated. Limosilactobacillus reuteri DSM-17938 (L. reuteri DSM-17938) is a probiotic shown to be effective in pre-clinical models at suppressing neuronal responses to capsaicin, a transient receptor potential vanilloid agonist (TRPV1). OBJECTIVE Investigate the effects of DSM-17938 versus matched placebo on capsaicin-evoked coughs in mild allergic asthmatics. METHODS We performed a 4-visit, randomized, double-blind, placebo-controlled, two-way cross-over study comparing full dose cough responses with inhaled capsaicin in mild allergic asthmatics after 1 month of treatment with DSM-17938 compared with matched placebo. Randomization and allocation to trial group were carried out by a central computer system. Histamine skin prick testing, airway hyper-responsiveness and inflammatory cells in induced sputum were measured at every visit. Blood was collected to extract PBMCs and stimulated with CD3/CD28 to ascertain the effects of DSM-17938 /placebo on T-cell cytokine responses. RESULTS Seventeen subjects were recruited and 15 completed the study (8 females, mean age 27.3 years). There was no difference in the change in maximum capsaicin-evoked coughs (Emax) after treatment with L. reuteri DSM-17938 compared with placebo [mean difference 2.07 coughs (95% CI -2.77 to 6.91, p = .38) or relative changes in geometric mean ratios for the dose evoking at least half the Emax (ED50) [1.05 (95% CI 0.31-3.58, p = .94)], concentration evoking 2 coughs (C2) [0.63 (0.26-1.53), p = .28] and 5 coughs (C5) [0.79 (0.25-2.50), p = .67]. There was no effect on histamine skin prick wheal size, intensity of itch sensation, methacholine PC20, airway inflammation or T-cell responses after stimulation with CD3/CD28. There were no serious adverse events. One subject developed a mild upper respiratory tract infection and another mild transient nausea whilst on DSM-17938. CONCLUSION In this small study in adults with mild allergic asthma, we found no evidence that L. reuteri DSM-17938 has any systemic effects on airway nerves, smooth muscle, sputum inflammatory cells, skin responses or T-cell responses after oral consumption. TRIAL REGISTRATION Clinicaltrials.gov Identifier: NCT03603522.
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Association Between Intravenous Magnesium Therapy in the Emergency Department and Subsequent Hospitalization Among Pediatric Patients With Refractory Acute Asthma: Secondary Analysis of a Randomized Clinical Trial.
Schuh, S, Freedman, SB, Zemek, R, Plint, AC, Johnson, DW, Ducharme, F, Gravel, J, Thompson, G, Curtis, S, Stephens, D, et al
JAMA network open. 2021;(7):e2117542
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IMPORTANCE Despite guidelines recommending administration of intravenous (IV) magnesium sulfate for refractory pediatric asthma, the number of asthma-related hospitalizations has remained stable, and IV magnesium therapy is independently associated with hospitalization. OBJECTIVE To examine the association between IV magnesium therapy administered in the emergency department (ED) and subsequent hospitalization among pediatric patients with refractory acute asthma after adjustment for patient-level variables. DESIGN, SETTING, AND PARTICIPANTS This post hoc secondary analysis of a double-blind randomized clinical trial of children with acute asthma treated from September 26, 2011, to November 19, 2019, at 7 Canadian tertiary care pediatric EDs was conducted between September and November 2020. In the randomized clinical trial, 816 otherwise healthy children aged 2 to 17 years with Pediatric Respiratory Assessment Measure (PRAM) scores of 5 points or higher after initial therapy with systemic corticosteroids and inhaled albuterol with ipratropium bromide were randomly assigned to 3 nebulized treatments of albuterol plus either magnesium sulfate or 5.5% saline placebo. EXPOSURES Intravenous magnesium sulfate therapy (40-75 mg/kg). MAIN OUTCOMES AND MEASURES The association between IV magnesium therapy in the ED and subsequent hospitalization for asthma was assessed using multivariable logistic regression analysis. Analyses were adjusted for year epoch at enrollment, receipt of IV magnesium, PRAM score after initial therapy and at ED disposition, age, sex, duration of respiratory distress, previous intensive care unit admission for asthma, hospitalizations for asthma within the past year, atopy, and receipt of oral corticosteroids within 48 hours before arrival in the ED, nebulized magnesium, and additional albuterol after inhaled magnesium or placebo, with site as a random effect. RESULTS Among the 816 participants, the median age was 5 years (interquartile range, 3-7 years), 517 (63.4%) were boys, and 364 (44.6%) were hospitalized. A total of 215 children (26.3%) received IV magnesium, and 190 (88.4%) of these children were hospitalized compared with 174 of 601 children (29.0%) who did not receive IV magnesium. Multivariable factors associated with hospitalization were IV magnesium receipt from 2011 to 2016 (odds ratio [OR], 22.67; 95% CI, 6.26-82.06; P < .001) and from 2017 to 2019 (OR, 4.19; 95% CI, 1.99-8.86; P < .001), use of additional albuterol (OR, 5.94; 95% CI, 3.52-10.01; P < .001), and increase in PRAM score at disposition (per 1-U increase: OR, 2.24; 95% CI, 1.89-2.65; P < .001). In children with a disposition PRAM score of 3 or lower, receipt of IV magnesium therapy was associated with hospitalization (OR, 8.52; 95% CI, 2.96-24.41; P < .001). CONCLUSIONS AND RELEVANCE After adjustment for patient-level characteristics, receipt of IV magnesium therapy after initial asthma treatment in the ED was associated with subsequent hospitalization. This association also existed among children with mild asthma at ED disposition. Evidence of a benefit of IV magnesium regarding hospitalization may clarify its use in the treatment of refractory pediatric asthma. TRIAL REGISTRATION ClinicalTrials.gov: NCT01429415.
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Asthma and high-intensity interval training have no effect on clustered cardiometabolic risk or arterial stiffness in adolescents.
McNarry, MA, Lester, L, Ellins, EA, Halcox, JP, Davies, G, Winn, CON, Mackintosh, KA
European journal of applied physiology. 2021;(7):1967-1978
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PURPOSE Cardiometabolic risk, including arterial stiffness, is increasing in youth. Those with asthma are suggested to be particularly at risk of cardiovascular disease. Efficient and effective strategies are required to prevent the atherosclerotic process in youth. The purpose of this study was to investigate the effect of 6 months high-intensity interval training (HIIT) on cardiometabolic risk in youth with and without asthma. METHODS 65 adolescents (31 mild asthma; 34 non-asthma) were recruited, 32 (16 asthma) of whom were randomly allocated to receive HIIT three times per week for 6 months. At baseline, mid-intervention, post-intervention and at a 3-month follow-up, anthropometric, metabolic and vascular determinants of cardiometabolic risk were assessed. Following principal component analysis (PCA), linear mixed models were used to assess the influence of asthma, HIIT and their interaction. RESULTS Seven factors were identified which explained 88% of the common variance shared among the parameters. Those with asthma demonstrated lower arterial stiffness factor scores mid-intervention (P = 0.047) and lower cholesterol factor scores post-intervention (P = 0.022) but there was no effect of the intervention, or interaction effects, on any PCA-identified factor, at any time-point. HIIT was associated with a lower low-density lipoprotein and diastolic blood pressure at mid-intervention. DISCUSSION Neither arterial stiffness nor clustered cardiometabolic risk are influenced by HIIT in adolescents with or without asthma, despite important changes in blood lipid and pressure profiles. Blood pressure, augmentation and pulse wave velocity should be considered physiologically distinct constructs and as potential markers of cardiovascular health.
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Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial.
Andújar-Espinosa, R, Salinero-González, L, Illán-Gómez, F, Castilla-Martínez, M, Hu-Yang, C, Ruiz-López, FJ
Thorax. 2021;(2):126-133
Abstract
BACKGROUND The relationship between asthma and vitamin D deficiency has been known for some time. However, interventional studies conducted in this regard have shown conflicting results. OBJECTIVE To evaluate the efficacy of vitamin D supplementation in asthmatic patients in improving the degree of control of asthma. METHODS Randomised, triple-blind, placebo-controlled, parallel-group study in adult asthmatic patients with serum 25-hydroxyvitamin-D3 <30 ng/mL. The intervention group received oral supplementation with 16 000 IU of calcifediol per week, and the control group had placebo added to their usual asthma treatment. The study period was 6 months. The primary endpoint was the degree of asthma control as determined by the asthma control test (ACT). Secondary endpoints included quality of life measured using the mini Asthma Quality of Life Questionnaire, the number of asthma attacks, oral corticosteroid cycles, the dose of inhaled corticosteroids, number of emergency visits, unscheduled consultations with the primary care physician and hospitalisations for asthma. RESULTS One hundred and twelve patients were randomised (mean age 55 years, with 87 (78%) being women). Of the 112 patients, 106 (95%) completed the trial. Half the patients (56) were assigned to the intervention group and the other half to the control group. A statistically significant clinical improvement was observed in the intervention group (+3.09) compared with the control group (-0.57) (difference 3.66 (95% CI 0.89 to 5.43); p<0.001) as measured using ACT scores. Among the secondary endpoints, a significant improvement in the quality of life was found in the intervention group (5.34), compared with the control group (4.64) (difference 0.7 (95% CI 0.15 to 1.25); p=0.01). CONCLUSION Among adults with asthma and vitamin D deficiency, supplementation with weekly oral calcifediol compared with placebo improved asthma control over 6 months. Further research is needed to assess long-term efficacy and safety. TRIAL REGISTRATION NUMBER NCT02805907.
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Effect of Nebulized Magnesium vs Placebo Added to Albuterol on Hospitalization Among Children With Refractory Acute Asthma Treated in the Emergency Department: A Randomized Clinical Trial.
Schuh, S, Sweeney, J, Rumantir, M, Coates, AL, Willan, AR, Stephens, D, Atenafu, EG, Finkelstein, Y, Thompson, G, Zemek, R, et al
JAMA. 2020;(20):2038-2047
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IMPORTANCE While intravenous magnesium decreases hospitalizations in refractory pediatric acute asthma, it is variably used because of invasiveness and safety concerns. The benefit of nebulized magnesium to prevent hospitalization is unknown. OBJECTIVE To evaluate the effectiveness of nebulized magnesium in children with acute asthma remaining in moderate or severe respiratory distress after initial therapy. DESIGN, SETTING, AND PARTICIPANTS A randomized double-blind parallel-group clinical trial from September 26, 2011, to November 19, 2019, in 7 tertiary-care pediatric emergency departments in Canada. The participants were otherwise healthy children aged 2 to 17 years with moderate to severe asthma defined by a Pediatric Respiratory Assessment Measure (PRAM) score of 5 or greater (on a 12-point scale) after a 1-hour treatment with an oral corticosteroid and 3 inhaled albuterol and ipratropium treatments. Of 5846 screened patients, 4332 were excluded for criteria, 273 declined participation, 423 otherwise excluded, 818 randomized, and 816 analyzed. INTERVENTIONS Participants were randomized to 3 nebulized albuterol treatments with either magnesium sulfate (n = 410) or 5.5% saline placebo (n = 408). MAIN OUTCOMES AND MEASURES The primary outcome was hospitalization for asthma within 24 hours. Secondary outcomes included PRAM score; respiratory rate; oxygen saturation at 60, 120, 180, and 240 minutes; blood pressure at 20, 40, 60, 120, 180, and 240 minutes; and albuterol treatments within 240 minutes. RESULTS Among 818 randomized patients (median age, 5 years; 63% males), 816 completed the trial (409 received magnesium; 407, placebo). A total of 178 of the 409 children who received magnesium (43.5%) were hospitalized vs 194 of the 407 who received placebo (47.7%) (difference, -4.2%; absolute risk difference 95% [exact] CI, -11% to 2.8%]; P = .26). There were no significant between-group differences in changes from baseline to 240 minutes in PRAM score (difference of changes, 0.14 points [95% CI, -0.23 to 0.50]; P = .46); respiratory rate (0.17 breaths/min [95% CI, -1.32 to 1.67]; P = .82); oxygen saturation (-0.04% [95% CI, -0.53% to 0.46%]; P = .88); systolic blood pressure (0.78 mm Hg [95% CI, -1.48 to 3.03]; P = .50); or mean number of additional albuterol treatments (magnesium: 1.49, placebo: 1.59; risk ratio, 0.94 [95% CI, 0.79 to 1.11]; P = .47). Nausea/vomiting or sore throat/nose occurred in 17 of the 409 children who received magnesium (4%) and 5 of the 407 who received placebo (1%). CONCLUSIONS AND RELEVANCE Among children with refractory acute asthma in the emergency department, nebulized magnesium with albuterol, compared with placebo with albuterol, did not significantly decrease the hospitalization rate for asthma within 24 hours. The findings do not support use of nebulized magnesium with albuterol among children with refractory acute asthma. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01429415.
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Short course gamma tocopherol did not mitigate effects of ozone on airway inflammation in asthmatics.
Burbank, AJ, Hernandez, ML, Robinette, C, Wang, T, Zhou, H, Alexis, N, Bennett, WD, Peden, DB
Inhalation toxicology. 2020;(7):279-281
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INTRODUCTION Exposure to elevated ambient ozone levels has been associated with exacerbation of asthma, likely mediated by oxidative stress. We have shown that supplementation with the antioxidant vitamin E isoform, gamma tocopherol, mitigates the inflammatory effects of inhaled endotoxin exposure, a key component of ambient air particulate matter. OBJECTIVE The objective of the current study was to assess the efficacy of gamma tocopherol for mitigating pulmonary effects of ozone, using an abbreviated dosing regimen that could be rapidly begun when high ozone days are anticipated. MATERIALS AND METHODS We conducted a randomized, double blind, placebo-controlled crossover study of adults with mild asthma who were pre-treated with gamma tocopherol-enriched supplement and exposed to 0.25 ppm ozone for 3 hours. Induced sputum samples were obtained before and after ozone exposure to measure airway inflammation. Mucociliary clearance was estimated using gamma scintigraphy. RESULTS With the short course of gamma tocopherol pre-treatment, we found no significant effect on ozone-induced airway inflammation. A transient slowing of clearance in the large airways was seen following ozone exposure in the placebo treatment period that was not present during gamma tocopherol treatment. DISCUSSION Short course gamma tocopherol did not protect against ozone-induced airway inflammation. Future work will focus on the efficacy of longer courses of gamma tocopherol supplementation for mitigating pollutant-induced health effects. The early transient ozone effect on airway clearance as well as the impact of gamma tocopherol on this effect will be further explored in future studies.
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The Impact of Food Histamine Intake on Asthma Activity: A Pilot Study.
Vassilopoulou, E, Konstantinou, GN, Dimitriou, A, Manios, Y, Koumbi, L, Papadopoulos, NG
Nutrients. 2020;(11)
Abstract
Asthma is a complex chronic inflammatory disorder. Diet's impact on asthma symptoms is controversial. The objective of this pilot crossover, randomized, two-period study was to examine the effect of dietary histamine intake on asthma symptoms in twenty-one children with mild intermittent asthma. Children were randomly assigned to either a high- or low-histamine diet, based on the Mediterranean pattern, for 4 weeks. After a 2-week washout period, patients crossed to the alternative diet for 4 additional weeks. Asthma symptoms were assessed at baseline and after the completion of each diet period by a clinician. Daily symptoms and peak flow were recorded throughout the intervention. Adherence to the dietary intervention was assessed via analysis of four random 24-h recalls, for each intervention period. Eighteen children completed the study. Significantly higher mean air flow obstruction was recorded and a trend for prolonged and more severe symptoms was observed during the high-histamine period. Diet may have an active and direct impact on asthma symptoms. Food choice is affected and/or may affect symptoms in children with mild asthma. Diet intervention is promising yet challenging, for asthma control.
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[Influence of five-in-one management mode on disease prevention and control of school children with asthma].
Lu, L, Lin, RJ, Guan, RZ, Liu, YJ, Wang, XY
Zhonghua er ke za zhi = Chinese journal of pediatrics. 2019;(11):870-875
Abstract
Objective: To investigate the influence of five-in-one management mode(standardized asthma treatment, asthma diary, peak expiratory flow (PEF) monitoring, reasonable diet and physical exercise) on disease prevention and control of school children with asthma. Methods: From April to October 2018, 70 children with asthma in clinical remission were selected from Affiliated Hospital of Qingdao University using randomized controlled study design. These children were randomly divided into study group and control group, with 35 cases in each group. In the study group, 5 cases were lost to follow-up, and 30 cases were actually enrolled. In the control group, 6 cases were lost to follow-up, and 29 cases were actually enrolled. Children in the control group received routine medication and regular outpatient consultation, and children in the study group received the five-in-one asthma management model. In the first time of seeing a doctor, after 3 months and 6 months of follow-up, asthma control test score, medication compliance index score and lung function index (forced expiratory volume in 1 second (FEV1), PEF were evaluated respectively.Parental satisfaction, asthma acute episodes, weight, height and biochemical index were recorded during the 6 months of follow-up. Pulmonary function index, asthma control score and body mass index of overweight children with asthma were compared with t-test, medication compliance was compared with chi-square test, and the rank sum test was used for the comparison of the number of emergency visits of asthma attacks and parents' satisfaction. Results: A total of 59 children with asthma were included, among them 30 were in the study group (8.1±1.5) years old and 29 in the control group (9.2±1.1) years old. After 3 months of follow-up, FEV1, PEF, asthma control score in the study group were (86.3±1.5)%, (83.3±2.4)%, (24.7±2.6) points respectively; and in the control group, FEV1, PEF, asthma control score were (84.4±2.5)%, (82.2±1.9)%, (21.1±1.3) points respectively. The indicators in the study group were higher than those in the control group (t=3.62, 1.97, 6.64, P<0.05). After 6 months of follow-up, FEV1, PEF, asthma control score in the study group were (88.4±2.3)%, (85.4±2.2)%, (26.8±1.8) points respectively; and in the control group, FEV1, PEF, asthma control score were (85.5±1.9)%, (83.2±1.7)%, (22.5±1.4) points respectively. The indicators in the study group were significantly higher than those in the control group (t=5.34, 4.24, 10.41, P<0.05). During the 6-month follow up, the number of emergency visits of asthma attacks in the study group and in the control group were 0.42(0.36, 0.51) and 0.92(0.72, 1.27) respectively. The indicator in the study group was significantly lower than that in the control group (Z=3.21, P<0.05). After 3 months of follow-up, the proportions of children with good compliance in the study group and control group were 67% (20/30) and 62% (18/29), the proportions of poor compliance were 27% (8/30) and 34% (10/29), the proportions of non-compliance were 7% (2/30) and 7% (2/29). There were no statistically significant differences (χ(2)=0.14, 0.43, 0.00, P=0.71, 0.51, 0.97). After 6 months of follow-up, the proportions of children with good compliance in the study group and control group were 87% (26/30) and 69% (20/29), the proportion of poor compliance were 10% (3/30) and 28% (8/29), the proportion of non-compliance were 3% (1/30) and 7% (2/29), There were no statistically significant differences (χ(2)=2.70, 3.00, 0.39, P=0.10, 0.08, 0.53). After 6 months of follow-up, the number of great satisfaction, satisfaction and dissatisfaction in the study group were 20, 10 and 0 respectively, the satisfaction rate was 100%, meanwhile those indicators in the control group were 4, 15 and 10 respectively, the satisfaction rate was 66%, The indicator in the study group was significantly higher than that in the control group (Z=4.60, P<0.05). Conclusions: The application of "five-in-one" asthma management model (standardized asthma treatment, asthma diary, PEF monitoring, reasonable diet and physical exercise) for school-age children with asthma can significantly improve lung function, as well as reduce the number of acute asthma attacks. It has a high parent satisfaction, therefore it should be recommended for clinical implementation.
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Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients.
Vogelberg, C, Szefler, SJ, Vrijlandt, EJLE, Boner, AL, Engel, M, El Azzi, G, Vulcu, SD, Moroni-Zentgraf, PM, Eickmeier, O, Hamelmann, EH
The European respiratory journal. 2019;(6)
Abstract
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.