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      The Efficacy and Safety of First-Line Single-Inhaler Triple versus Dual Therapy in Controller-Naïve and Symptomatic Adults with Asthma: A Preliminary Retrospective Cohort Study

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          Abstract

          Purpose

          The efficacy and safety of first-line triple and dual therapy remain unclear because the stepwise strategy is a worldwide standard in controller-naïve asthma. A preliminary retrospective cohort study was conducted to investigate the efficacy and safety of first-line triple and dual therapy for managing controller-naïve and symptomatic adult patients with asthma.

          Patients and Methods

          Patients with asthma who received first-line single-inhaler triple therapy (SITT) or dual therapy (SIDT) for at least 8 weeks were selected between December 1, 2020, and May 31, 2021, in Fujiki Medical and Surgical Clinic, Miyazaki, Japan. Data on daytime and nighttime visual analog scale (VAS) scores, lung function tests, fractional exhaled nitrogen oxide (F ENO), and adverse events were compared between SITT and SIDT pre- and post-treatment.

          Results

          The SITT significantly improved the nighttime, but not daytime, VAS scores better than the SIDT 2 weeks post-treatment ( P = 0.0026), whereas SITT and SIDT significantly improved daytime and nighttime VAS scores after treatment compared to baseline. Both therapies also significantly improved lung functions and F ENO post-treatment. The proportion of patients achieving complete control in the nighttime VAS scores after SITT was significantly higher than that four ( P = 0.0186) and 8 weeks ( P = 0.0061) after SIDT. Only patients with SITT experienced dry mouth.

          Conclusion

          Our study demonstrated that first-line SITT and SIDT were effective, and SITT improved disease control faster than SIDT in controller-naïve and symptomatic adult patients with asthma. The first-line SITT may contribute to faster and better control levels in symptomatic patients with asthma.

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          Most cited references48

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          Standardisation of spirometry.

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            Development and validation of a questionnaire to measure asthma control

            International guidelines on asthma management indicate that the primary goal of treatment should be optimum asthma control. The aim of this study was to develop and validate the Asthma Control Questionnaire (ACQ). The authors generated a list of all symptoms used to assess control and sent it to 100 asthma clinicians who were members of guidelines committees (18 countries). They scored each symptom for its importance in evaluating asthma control. From the 91 responses, the five highest scoring symptoms were selected for the ACQ. In addition, there is one question on beta2-agonist use and another on airway calibre (total questions=7). The ACQ was tested in a 9-week observational study of 50 adults with symptomatic asthma. The ACQ and other measures of asthma health status were assessed at baseline, 1, 5 and 9 weeks. In patients whose asthma was stable between clinic visits, reliability of the ACQ was high (intraclass correlation coefficient (ICC)=0.90). The questionnaire was very responsive to change in asthma control (p<0.0001). Cross-sectional and longitudinal validity were supported by correlations between the ACQ and other measures of asthma health status being close to a priori predictions. In conclusion, the Asthma Control Questionnaire has strong evaluative and discriminative properties and can be used with confidence to measure asthma control.
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              Development of the asthma control test: a survey for assessing asthma control.

              Asthma guidelines indicate that the goal of treatment should be optimum asthma control. In a busy clinic practice with limited time and resources, there is need for a simple method for assessing asthma control with or without lung function testing. The objective of this article was to describe the development of the Asthma Control Test (ACT), a patient-based tool for identifying patients with poorly controlled asthma. A 22-item survey was administered to 471 patients with asthma in the offices of asthma specialists. The specialist's rating of asthma control after spirometry was also collected. Stepwise regression methods were used to select a subset of items that showed the greatest discriminant validity in relation to the specialist's rating of asthma control. Internal consistency reliability was computed, and discriminant validity tests were conducted for ACT scale scores. The performance of ACT was investigated by using logistic regression methods and receiver operating characteristic analyses. Five items were selected from regression analyses. The internal consistency reliability of the 5-item ACT scale was 0.84. ACT scale scores discriminated between groups of patients differing in the specialist's rating of asthma control (F = 34.5, P <.00001), the need for change in patient's therapy (F = 40.3, P <.00001), and percent predicted FEV(1) (F = 4.3, P =.0052). As a screening tool, the overall agreement between ACT and the specialist's rating ranged from 71% to 78% depending on the cut points used, and the area under the receiver operating characteristic curve was 0.77. Results reinforce the usefulness of a brief, easy to administer, patient-based index of asthma control.
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                Author and article information

                Journal
                J Asthma Allergy
                J Asthma Allergy
                jaa
                Journal of Asthma and Allergy
                Dove
                1178-6965
                28 February 2023
                2023
                : 16
                : 227-237
                Affiliations
                [1 ]Fujiki Medical and Surgical Clinic , Miyazaki, Japan
                [2 ]Division of Respirology, Neurology, and Rheumatology, Department of Medicine, Kurume University School of Medicine , Kurume, Japan
                [3 ]Biostatistics Center, Kurume University School of Medicine , Kurume, Japan
                Author notes
                Correspondence: Tomotaka Kawayama, Division of Respirology, Neurology, and Rheumatology, Department of Medicine, Kurume University School of Medicine , 67 Asahi-machi, Kurume, 830-0011, Japan, Tel +81-0942-31-7560, Email kawayama_tomotaka@med.kurume-u.ac.jp
                Article
                401505
                10.2147/JAA.S401505
                9985402
                36879847
                d57be2a6-27a2-4e71-a598-9abac230de40
                © 2023 Fujiki et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 14 December 2022
                : 06 February 2023
                Page count
                Figures: 4, Tables: 3, References: 49, Pages: 11
                Funding
                Funded by: no funding for this work;
                There was no funding for this work.
                Categories
                Original Research

                Immunology
                adult,asthma,cohort study,corticosteroids,japanese
                Immunology
                adult, asthma, cohort study, corticosteroids, japanese

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