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      Effect of twice daily inhaled albuterol on cardiopulmonary exercise outcomes, dynamic hyperinflation, and symptoms in secondhand tobacco-exposed persons with preserved spirometry and air trapping: a randomized controlled trial

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          Abstract

          Background

          In tobacco-exposed persons with preserved spirometry (active smoking or secondhand smoke [SHS] exposure), air trapping can identify a subset with worse symptoms and exercise capacity. The physiologic nature of air trapping in the absence of spirometric airflow obstruction remains unclear. The aim of this study was to examine the underlying pathophysiology of air trapping in the context of preserved spirometry and to determine the utility of bronchodilators in SHS tobacco-exposed persons with preserved spirometry and air trapping.

          Methods

          We performed a double-blinded placebo-controlled crossover randomized clinical trial in nonsmoking individuals at risk for COPD due to exposure to occupational SHS who had preserved spirometry and air trapping defined as either a residual volume-to-total lung capacity ratio (RV/TLC) > 0.35 or presence of expiratory flow limitation (EFL, overlap of tidal breathing on maximum expiratory flow-volume loop) on spirometry at rest or during cardiopulmonary exercise testing (CPET). Those with asthma or obesity were excluded. Participants underwent CPET at baseline and after 4-week trials of twice daily inhalation of 180 mcg of albuterol or placebo separated by a 2-week washout period. The primary outcome was peak oxygen consumption (VO 2) on CPET. Data was analyzed by both intention-to-treat and per-protocol based on adherence to treatment prescribed.

          Results

          Overall, 42 participants completed the entire study (66 ± 8 years old, 91% female; forced expiratory volume in 1 s [FEV 1] = 103 ± 16% predicted; FEV 1 to forced vital capacity [FVC] ratio = 0.75 ± 0.05; RV/TLC = 0.39 ± 0.07; 85.7% with EFL). Adherence was high with 87% and 93% of prescribed doses taken in the treatment and placebo arms of the study, respectively ( P = 0.349 for comparison between the two arms). There was no significant improvement in the primary or secondary outcomes by intention-to-treat or per-protocol analysis. In per-protocol subgroup analysis of those with RV/TLC > 0.35 and ≥ 90% adherence ( n = 27), albuterol caused an improvement in peak VO 2 (parameter estimate [95% confidence interval] = 0.108 [0.014, 0.202]; P = 0.037), tidal volume, minute ventilation, dynamic hyperinflation, and oxygen-pulse (all P < 0.05), but no change in symptoms or physical activity.

          Conclusions

          Albuterol may improve exercise capacity in the subgroup of SHS tobacco-exposed persons with preserved spirometry and substantial air trapping. These findings suggest that air trapping in pre-COPD may be related to small airway disease that is not considered significant by spirometric indices of airflow obstruction.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12890-023-02808-7.

          Key messages

          What is already known on this topic?

          Many people who have been exposed to tobacco smoke (direct or indirect) but have preserved spirometry show abnormal lung volumes suggestive of presence of air trapping. The physiologic nature of air trapping in the absence of spirometric airflow obstruction remains unclear.

          What this study adds?

          Albuterol may improve ventilation and exercise capacity in secondhand tobacco-exposed persons with preserved spirometry and lung volumes suggestive of air trapping.

          How this study might affect research, practice, or policy?

          Air trapping in pre-COPD may be related to small airway disease that is not considered significant by spirometric indices of airflow obstruction. Stratification of the tobacco-exposed persons with preserved spirometry by lung volumes and air trapping may help in identifying a subset who do benefit from the use of bronchodilators.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12890-023-02808-7.

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          Most cited references61

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          International physical activity questionnaire: 12-country reliability and validity.

          Physical inactivity is a global concern, but diverse physical activity measures in use prevent international comparisons. The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. Between 1997 and 1998, an International Consensus Group developed four long and four short forms of the IPAQ instruments (administered by telephone interview or self-administration, with two alternate reference periods, either the "last 7 d" or a "usual week" of recalled physical activity). During 2000, 14 centers from 12 countries collected reliability and/or validity data on at least two of the eight IPAQ instruments. Test-retest repeatability was assessed within the same week. Concurrent (inter-method) validity was assessed at the same administration, and criterion IPAQ validity was assessed against the CSA (now MTI) accelerometer. Spearman's correlation coefficients are reported, based on the total reported physical activity. Overall, the IPAQ questionnaires produced repeatable data (Spearman's rho clustered around 0.8), with comparable data from short and long forms. Criterion validity had a median rho of about 0.30, which was comparable to most other self-report validation studies. The "usual week" and "last 7 d" reference periods performed similarly, and the reliability of telephone administration was similar to the self-administered mode. The IPAQ instruments have acceptable measurement properties, at least as good as other established self-reports. Considering the diverse samples in this study, IPAQ has reasonable measurement properties for monitoring population levels of physical activity among 18- to 65-yr-old adults in diverse settings. The short IPAQ form "last 7 d recall" is recommended for national monitoring and the long form for research requiring more detailed assessment.
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            Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations.

            The aim of the Task Force was to derive continuous prediction equations and their lower limits of normal for spirometric indices, which are applicable globally. Over 160,000 data points from 72 centres in 33 countries were shared with the European Respiratory Society Global Lung Function Initiative. Eliminating data that could not be used (mostly missing ethnic group, some outliers) left 97,759 records of healthy nonsmokers (55.3% females) aged 2.5-95 yrs. Lung function data were collated and prediction equations derived using the LMS method, which allows simultaneous modelling of the mean (mu), the coefficient of variation (sigma) and skewness (lambda) of a distribution family. After discarding 23,572 records, mostly because they could not be combined with other ethnic or geographic groups, reference equations were derived for healthy individuals aged 3-95 yrs for Caucasians (n=57,395), African-Americans (n=3,545), and North (n=4,992) and South East Asians (n=8,255). Forced expiratory value in 1 s (FEV(1)) and forced vital capacity (FVC) between ethnic groups differed proportionally from that in Caucasians, such that FEV(1)/FVC remained virtually independent of ethnic group. For individuals not represented by these four groups, or of mixed ethnic origins, a composite equation taken as the average of the above equations is provided to facilitate interpretation until a more appropriate solution is developed. Spirometric prediction equations for the 3-95-age range are now available that include appropriate age-dependent lower limits of normal. They can be applied globally to different ethnic groups. Additional data from the Indian subcontinent and Arabic, Polynesian and Latin American countries, as well as Africa will further improve these equations in the future.
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              Development and first validation of the COPD Assessment Test.

              There is need for a validated short, simple instrument to quantify chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment and communication between patient and physician. Current health-related quality of life questionnaires provide valid assessment of COPD, but are complex, which limits routine use. The aim of the present study was to develop a short validated patient-completed questionnaire, the COPD Assessment Test (CAT), assessing the impact of COPD on health status. 21 candidate items identified through qualitative research with COPD patients were used in three prospective international studies (Europe and the USA, n = 1,503). Psychometric and Rasch analyses identified eight items fitting a unidimensional model to form the CAT. Items were tested for differential functioning between countries. Internal consistency was excellent: Cronbach's alpha = 0.88. Test re-test in stable patients (n = 53) was very good (intra-class correlation coefficient 0.8). In the sample from the USA, the correlation with the COPD-specific version of the St George's Respiratory Questionnaire was r = 0.80. The difference between stable (n = 229) and exacerbation patients (n = 67) was five units of the 40-point scale (12%; p<0.0001). The CAT is a short, simple questionnaire for assessing and monitoring COPD. It has good measurement properties, is sensitive to differences in state and should provide a valid, reliable and standardised measure of COPD health status with worldwide relevance.
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                Author and article information

                Contributors
                mehrdad.arjomandi@ucsf.edu
                Journal
                BMC Pulm Med
                BMC Pulm Med
                BMC Pulmonary Medicine
                BioMed Central (London )
                1471-2466
                20 January 2024
                20 January 2024
                2024
                : 24
                : 44
                Affiliations
                [1 ]Department of Biomedical Informatics and Medical Education, University of Washington, ( https://ror.org/00cvxb145) Seattle, WA USA
                [2 ]GRID grid.429734.f, Pulmonary and Critical Care Section, , San Francisco Veterans Affairs Health Care System, ; Building 203, Room 3A-128, Mailstop 111-D, 4150 Clement Street, San Francisco, CA 94121 USA
                [3 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Medicine, Division of Pulmonary and Critical Care Medicine, , University of California, ; San Francisco, CA USA
                [4 ]Carver College of Medicine, University of Iowa, ( https://ror.org/036jqmy94) Iowa City, USA
                [5 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Medicine, Division of Occupational, Environmental, and Climate Medicine, , University of California, ; San Francisco, CA USA
                Article
                2808
                10.1186/s12890-023-02808-7
                10799390
                38245665
                8447a9e9-a93d-4584-8b2d-88b25635016f
                © This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 9 June 2023
                : 7 December 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100005640, Flight Attendant Medical Research Institute;
                Award ID: 012500WG and CIA190001
                Award ID: 012500WG and CIA190001
                Award ID: 012500WG and CIA190001
                Award ID: 012500WG and CIA190001
                Award ID: 012500WG and CIA190001
                Award ID: 012500WG and CIA190001
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000092, U.S. National Library of Medicine;
                Award ID: T15LM007442
                Award Recipient :
                Categories
                Research
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2024

                Respiratory medicine
                secondhand tobacco smoke,air trapping,spirometric obstruction,tobacco-exposed person,pre-copd,exercise capacity,bronchodilation

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