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Objective: To compare the bioavailability of two metered-dose inhalers (MDIs) containing salbutamol (albuterol) by means of a spirometric evaluation of the time-course of bronchodilation in patients with moderate asthma. Design and patients: 25 asthmatic patients (12 males, 13 females) participated in the study. Study participants received salbutamol 200μg (Ventolin, GlaxoSmithKline Mexico City, or Assal, Salus SA de CV, Mexico City)on separate days according to a double-blind, crossover design. Spirometry was performed 30 minutes before and at selected times during the 8 hours following drug administration. The time-course of changes in forced expiratory volume in 1 second (FEV) [transformed to individual percentage of maximal response] was used to compare the formulations. Pharmacodynamic parameters, maximal effect (E) and area under the percentage of response-time curve (AUC) were obtained and compared by analysis of variance, and ratios of AUC and E and 90% confidence limits were calculated. Results: Values obtained for E were 94.81 ± 2.19% and 84.45 ± 3.44% for Ventolin and Assal, respectively, whereas values for AUC were 25 278 ± 1873 %•min and 18 155 ± 1806 %•min, respectively. Ratios were 89.1 and 71.8% with 90% confidence limits of 79.6 to 98.5% and 53.9 to 89.7% for E and AUC, respectively. The probability according to the two one-sided t-test of having values lower than 80% was higher than 0.05 for both AUC and E, indicating that the formulations tested are not bioequivalent. Conclusions: It is concluded that this method is suitable for comparing the bioavailability of MDI formulations of bronchodilatory agents and that the formulations tested were not bioequivalent. [ABSTRACT FROM AUTHOR]

Background: Asthma continues to be one of the most frequent chronic respiratory diseases in our country. New methods for diagnosis and treatment have been described; accordingly, the international guidelines were renewed., Objective: To create a national platform for the development of updated guidelines, solidly based on evidence: Comprehensive Asthma Management (Spanish acronym: MIA)., Methods: MIA uses the ADAPTE method. The MIA development group consists of experts in pulmonology-allergology-methodology and representatives of 13 institutions and societies of specialties that manage asthma. The international reference guidelines (selected with AGREE-II): GINA 2020, GEMA 5.0, BTS/SIGN 2019 and ATS/ERS consensus document 2014-2019 on severe asthma. MIA covers suspected asthma, diagnosis, treatment, and special groups. Key clinical questions were formulated on treatment steps 1-3, biomarkers and severe asthma., Results: Based on evidence, safety, cost and local reality, the core group developed responses. Through a Delphi process the broad MIA development group suggested adjustments until consensus was reached., Conclusion: A document was generated with multiple figures and algorithms, solidly based on evidence about asthma management, adjusted for Mexico with a broad base among different societies that participated in its development. It does not include guidelines for acute asthma.

Background: There was a need for a solid asthma guideline in Mexico to update and unify asthma management. Because high-quality asthma guidelines exist worldwide, in which the latest evidence on asthma management is summarized, the ADAPTE approach allows for the development of a national asthma guideline based on evidence from already existing guidelines, adapted to national needs., Objective: To fuse evidence from the best asthma guidelines and adapt it to local needs with the ADAPTE approach., Methods: The Appraisal of Guidelines for Research and Evaluation (AGREE) II asthma guidelines were evaluated by a core group to select 3 primary guidelines. For each step of asthma management, clinical questions were formulated and replied according to (1) evidence in the primary guidelines, (2) safety, (3) Cost, and (4) patient preference. The Guidelines Development Group, composed of a broad range of experts from medical specialties, primary care physicians, and methodologists, adjusted the draft questions and replies in several rounds of a Delphi process and 3 face-to-face meetings, taking into account the reality of the situation in Mexico. We present the results of the pediatric asthma treatment part., Results: Selected primary guidelines are from the British Thoracic Society and Scottish Intercollegiate Guidelines Network (BTS/SIGN), Global Initiative for Asthma (GINA), and Spanish Guidelines on the Management of Asthma (GEMA) 2015, with 2016 updates. Recommendations or suggestions were made for asthma treatment in Mexico. In this article, the detailed analysis of the evidence present in the BTS/SIGN, GINA, and GEMA sections on the (non) pharmacologic treatment of pediatric asthma, education, and devices are presented for 2 age groups: children 5 years or younger and children 6 to 11 years old with asthma., Conclusion: For the pediatric treatment and patient education sections, applying the AGREE II and Delphi methods is useful to develop a scientifically sustained document, adjusted to the Mexican situation, as is the Mexican Guideline on Asthma., (Copyright © 2018 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: The need for a national guideline, with a broad basis among specialists and primary care physicians was felt in Mexico, to try unifying asthma management. As several high-quality asthma guidelines exist worldwide, it was decided to select the best three for transculturation., Methods: Following the internationally recommended methodology for guideline transculturation, ADAPTE, a literature search for asthma guidelines, published 1-1-2007 through 31-12-2015 was conducted. AGREE-II evaluations yielded 3/40 most suitable for transculturation. Their compound evidence was fused with local reality, patient preference, cost and safety considerations to draft the guideline document. Subsequently, this was adjusted by physicians from 12 national medical societies in several rounds of a Delphi process and 3 face-to-face meetings to reach the final version., Results: Evidence was fused from British Thoracic Society Asthma Guideline 2014, Global Initiative on Asthma 2015, and Guía Española del Manejo del Asma 2015 (2016 updates included). After 3 Delphi-rounds we developed an evidence-based document taking into account patient characteristics, including age, treatment costs and safety and best locally available medication., Conclusions: In cooperation pulmonologists, allergists, ENT physicians, paediatricians and GPs were able to develop an evidence-based document for the prevention, diagnosis and treatment of asthma and its exacerbations in Mexico.