Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged ≥4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study

Chipps, Bradley E.; Albers, Frank C.; Reilly, Laurence; Johnsson, Eva; Cappelletti, Christy; Papi, Alberto

doi:10.1136/bmjresp-2021-001077

Cited by 12 publications

(11 citation statements)

References 32 publications

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“…The study will recruit 1000 patients per treatment group for adults/adolescents and 50 patients per treatment group for patients aged 4-11 years. This study, if successful, will confirm salbutamol/budesonide pMDI as a rescue therapy irrespective of background asthma therapy [32]. The CARE study will be a 52-week phase III RCT on children aged 5 to 15 years with mild asthma treated either with budesonide-formoterol or salbutamol.…”

Section: Pico Question 1 In Children With Infrequent Symptoms Is Saba...mentioning

confidence: 80%

Maintenance Therapy for Children and Adolescents with Asthma: Guidelines and Recommendations from the Emilia-Romagna Asthma (ERA) Study Group

Fainardi,

Caffarelli,

Deolmi

et al. 2023

JCM

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Asthma is the most frequent chronic disease of childhood, affecting up to 20% of children worldwide. The main guidelines on asthma maintenance therapy in pediatrics suggest different approaches and describe different stages of asthma to determine the most appropriate treatment. This project aims to summarize the most recent evidence regarding maintenance therapy for asthma in children and adolescents. A multidisciplinary panel of experts was asked clinical questions regarding the treatment of children and adolescents with asthma. Overall, 10 clinical questions were addressed, and the search strategy included accessing electronic databases and a manual search of gray literature published in the last 25 years. After data extraction and narrative synthesis of results, recommendations were developed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) methodology. Results showed that the choice of medication depends on the severity of the child’s asthma, phenotype, age, preference, and individual factors. In addition to medications, the identification of comorbidities and modifiable factors is crucial to obtaining good control. Asthma in children is heterogeneous, and its evolution varies over time. Since most recommendations for asthma management in childhood are extrapolated from clinical studies performed in adults, more clinical trials specifically designed for young children should be conducted.

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Section: Pico Question 1 In Children With Infrequent Symptoms Is Saba...mentioning

confidence: 80%

Maintenance Therapy for Children and Adolescents with Asthma: Guidelines and Recommendations from the Emilia-Romagna Asthma (ERA) Study Group

Fainardi,

Caffarelli,

Deolmi

et al. 2023

JCM

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“…The MANDALA study demonstrating that salbutamol/budesonide can help control bronchoconstriction and slow airway inflammation. 24 A randomized controlled trial showed the use of ICS plus β 2 receptor agonists to reduce persistent cough after lobectomy. 12 The potential mechanism may be the comprehensive anti-inflammatory effect of corticosteroids.…”

Section: Discussionmentioning

confidence: 99%

Effects of Combined Use of Salbutamol/Budesonide in Thoracic Surgery on Postoperative Myocardial Injury (MINS) – A Prospective Randomized Clinical Trial

Lin¹,

Zhang²,

Huang³

et al. 2023

DDDT

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Purpose This study aims to investigate whether the administration of salbutamol/budesonide reduced the incidence of myocardial injury in thoracic surgery. Methods The randomized controlled trial included 298 patients over 45 and at high-risk for cardiovascular complications after lobectomy. Patients in the experimental group were treated with salbutamol/budesonide after anesthesia induction with fiberoptic bronchoscope. The primary outcome was the incidence rates of myocardial injury, assessed before and three days after the operation. The secondary outcome was respiratory function at each time point during the operation, including lung compliance and arterial partial pressure of oxygen, postoperative pulmonary and cardiovascular complications, hospital stay, pain score, and analgesic dosage. Results In the control group, the incidence of myocardial injury was 57/150 (38%), while that in the experimental group was 33/148 (22%); compared between the two groups, the difference in the incidence of myocardial injury was statistically significant. The dynamic compliance and static compliance at half an hour after the start of surgery in the experimental group were significantly improved. Before leaving the operating room, the difference in arterial oxygen partial pressure between the two groups was statistically significant. Conclusion Intraoperative administration of salbutamol/budesonide reduced the incidence of myocardial injury after thoracic surgery, improved lung function, and reduced the incidence of postoperative pulmonary complications.

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“…Treatment with ICS alone cannot modify the decrease in FEV1. 17,18 In patients with moderate-severe COPD, the combination of ICS with LABA is more effective in improving lung function, health status and reducing exacerbations. In addition, treatment with LABA/ICS fixed dose combination (FDC) has a significant effect compared to LABA alone, in patients with exacerbations a maximum of once a year.…”

Section: Discussionmentioning

confidence: 99%

Management of Stable Chronic Obstructive Pulmonary Disease : A Systematic Review

Hatulely

2023

JARMHS

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Introduction: The goal of drug treatment for chronic obstructive pulmonary disease (COPD) is to relieve symptoms and lower the chance of future problems like flare-ups, disease progression, and death. Because COPD is not all the same, people respond differently to drug treatments. The best way to treat COPD now is with precision medicine, which uses clinical and biomarker data to make treatment decisions that are best for each person. The aim: This article discusses management of stable chronic obstructive pulmonary disease. Methods: By comparing itself to the standards set by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020, this study was able to show that it met all of the requirements. So, the experts were able to make sure that the study was as up-to-date as it was possible to be. For this search approach, publications that came out between 2013 and 2023 were taken into account. Several different online reference sources, like Pubmed and SagePub, were used to do this. It was decided not to take into account review pieces, works that had already been published, or works that were only half done. Result: In the PubMed database, the results of our search brought up 68 articles, whereas the results of our search on SagePub brought up 32 articles. The results of the search conducted for the last year of 2013 yielded a total 31 articles for PubMed and 15 articles for SagePub. In the end, we compiled a total of 14 papers, 10 of which came from PubMed and four of which came from SagePub. We included four research that met the criteria. Conclusion: COPD treatment has evolved to match clinical characteristics and biomarkers to each patient. Hospitalizations and death have improved in triple combination treatment studies. However, COPD treatments are lacking, such as emphysema-slowing drugs. Despite progress, much remains.

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Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged ≥4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study

Cited by 12 publications

References 32 publications

Maintenance Therapy for Children and Adolescents with Asthma: Guidelines and Recommendations from the Emilia-Romagna Asthma (ERA) Study Group

Maintenance Therapy for Children and Adolescents with Asthma: Guidelines and Recommendations from the Emilia-Romagna Asthma (ERA) Study Group

Effects of Combined Use of Salbutamol/Budesonide in Thoracic Surgery on Postoperative Myocardial Injury (MINS) – A Prospective Randomized Clinical Trial

Management of Stable Chronic Obstructive Pulmonary Disease : A Systematic Review

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