scholarly journals 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

2021 ◽  
Vol 8 (1) ◽  
pp. e001077
Author(s):  
Bradley E Chipps ◽  
Frank C Albers ◽  
Laurence Reilly ◽  
Eva Johnsson ◽  
Christy Cappelletti ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Asthma Exacerbation ◽  
Rescue Therapy ◽  
Good Clinical Practice ◽  
Regulatory Requirements ◽  
Double Blind ◽  
Technical Requirements ◽  
Severe Asthma Exacerbation ◽  
Adults And Children ◽  
Fast Acting

IntroductionUncontrolled asthma is associated with substantial morbidity. While fast-acting bronchodilators provide quick relief from asthma symptoms, their use as rescue fails to address the underlying inflammation. Combining a short-acting beta2-agonist, such as albuterol (salbutamol), with an inhaled corticosteroid, such as budesonide, in a single inhaler as rescue therapy could help control both bronchoconstriction and inflammation, and reduce the risk of asthma exacerbations.Methods and analysisThe Phase 3 MANDALA study was designed to determine the efficacy of albuterol in combination with budesonide (albuterol/budesonide 180/160 µg or 180/80 µg, two actuations of 90/80 µg or 90/40 µg, respectively) versus albuterol (180 µg, two actuations of 90 µg) as rescue therapy in adult, adolescent and paediatric patients with moderate-to-severe asthma. This event-driven study enrolled symptomatic patients (3000 adults/adolescents and 100 children aged 4–11 years) who experienced ≥1 severe asthma exacerbation in the previous year and were receiving maintenance therapy for ≥3 months prior to study entry. The primary efficacy endpoint was time-to-first severe asthma exacerbation.Ethics and disseminationThe study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice and the applicable regulatory requirements.Trial registrationNCT03769090.

scholarly journals Management of severe asthma exacerbation: guidelines from the Société Française de Médecine d’Urgence, the Société de Réanimation de Langue Française and the French Group for Pediatric Intensive Care and Emergencies

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Philippe Le Conte ◽  
Nicolas Terzi ◽  
Guillaume Mortamet ◽  
Fekri Abroug ◽  
Guillaume Carteaux ◽  
...  
Keyword(s):  
Emergency Medicine ◽  
Intensive Care ◽  
Severe Asthma ◽  
Asthma Exacerbation ◽  
Pediatric Patients ◽  
Pediatric Intensive Care ◽  
Extensive Literature ◽  
Level Of Evidence ◽  
Severe Asthma Exacerbation ◽  
Evidence Grade

Abstract Background The French Emergency Medicine Society, the French Intensive Care Society and the Pediatric Intensive Care and Emergency Medicine French-Speaking Group edited guidelines on severe asthma exacerbation (SAE) in adult and pediatric patients. Results The guidelines were related to 5 areas: diagnosis, pharmacological treatment, oxygen therapy and ventilation, patients triage, specific considerations regarding pregnant women. The literature analysis and formulation of the guidelines were conducted according to the Grade of Recommendation Assessment, Development and Evaluation methodology. An extensive literature research was conducted based on publications indexed in PubMed™ and Cochrane™ databases. Of the 21 formalized guidelines, 4 had a high level of evidence (GRADE 1+/−) and 7 a low level of evidence (GRADE 2+/−). The GRADE method was inapplicable to 10 guidelines, which resulted in expert opinions. A strong agreement was reached for all guidelines. Conclusion The conjunct work of 36 experts from 3 scientific societies resulted in 21 formalized recommendations to help improving the emergency and intensive care management of adult and pediatric patients with SAE.

Emergency Management of Acute Severe Asthma Exacerbation in the Adult Population

2010 ◽  
Vol 1 (5) ◽  
pp. 174-179
Author(s):  
Sandra E. Marotta ◽  
Yuly Belchikov ◽  
Katherine Banker ◽  
Peter S. Marshall
Keyword(s):  
Emergency Management ◽  
Severe Asthma ◽  
Asthma Exacerbation ◽  
Adult Population ◽  
Acute Severe Asthma ◽  
Severe Asthma Exacerbation

scholarly journals Duration of the efficacy of omalizumab after treatment discontinuation in ‘real life’ severe asthma

Thorax ◽  
2017 ◽  
Vol 73 (8) ◽  
pp. 782-784 ◽  
Author(s):  
Maria del Carmen Vennera ◽  
Carlos Sabadell ◽  
Cesar Picado
Keyword(s):  
Prospective Study ◽  
Asthma Control ◽  
Severe Asthma ◽  
Asthma Exacerbation ◽  
Real Life ◽  
First Year ◽  
Severe Asthma Exacerbation ◽  
Optimal Duration ◽  
Open Prospective Study

Efficacy of omalizumab in severe asthma is well documented; however, the optimal duration of the treatment remains unclear. In an open prospective study, we sought to assess the persistence of response in subjects withdrawing from omalizumab treatment. We evaluated 49 patients who voluntarily accepted to discontinue omalizumab treatment after 6 years of therapy. Asthma relapse was defined as any severe asthma exacerbation associated with loss of asthma control. Twelve patients relapsed in the first year of follow-up, and 7 within 13 and 48 months. These results suggest that the effects of 6 years of omalizumab may persist after discontinuation of therapy in 60% of patients for at least 4 years.

scholarly journals Ketamine for Adults with Severe Asthma Exacerbation: A Systematic Review and Meta-analysis

2022 ◽  
Vol 2 (1) ◽  
pp. 91-97
Author(s):  
Fatimah AlShehri ◽  
Heetaf Aloqaily ◽  
Joud Enabi ◽  
Sharafaldeen Bin Nafisah
Keyword(s):  
Systematic Review ◽  
Severe Asthma ◽  
Asthma Exacerbation ◽  
Meta Analysis ◽  
World Health ◽  
Severe Asthma Exacerbation ◽  
Number Of Patients ◽  
Acute Asthma Exacerbation ◽  
Health Organization ◽  
Meta Analyses

BACKGROUND: Severe asthma mandates careful attention and timely management, and the benefit of ketamine in severe asthma exacerbations in adult patients require further exploration. METHODS: We conducted a systematic review and meta-analysis of the use of ketamine in cases of acute asthma exacerbation in adults. We searched PubMed, Google Scholar, Cochrane databases, and gray literature (ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform); we also searched the reference lists of included articles and any systematic reviews and meta-analyses identified therein. Our search covered the period from 1963 to August 20, 2021. Search terms were “ketamine” AND “asthma”. RESULTS: Of 25 540 articles, two studies were included in the analysis. The total number of patients included in the studies was 136 (68 in the ketamine groups and 68 in the placebo group). The pooled effect size was 0.30 (95% CI: -0.04, 0.63) favouring ketamine over placebo, p=0.08, (I2=0%, p=0.39). A paired t-test revealed that ketamine improved the mean peak expiratory flow rate (PEFR) from 242.4 (SD=146.23) to 286.95 (SD=182.22), p=0.33, representing an 18.38% improvement. CONCLUSION: Ketamine can induce a 30% improvement in PEFR, representing a small positive effect in the treatment of acute severe asthma exacerbation in the emergency department (ED). The improvement was not statistically significant; nonetheless, since the improvement could be as great as 63% versus only a 4% possibility of no benefit/harm, the benefit appears to considerably outweigh any harm.

Sign in / Sign up

Export Citation Format

Share Document