Longitudinal Follow-Up of Participants With Tobacco Exposure and Preserved Spirometry.

TitleLongitudinal Follow-Up of Participants With Tobacco Exposure and Preserved Spirometry.
Publication TypePublication
AuthorsMcKleroy W, Shing T, Anderson WH, Arjomandi M, Awan HAnees, Barjaktarevic I, R Barr G, Bleecker ER, Boscardin J, Bowler RP, Buhr RG, Criner GJ, Comellas AP, Curtis JL, Dransfield M, Doerschuk CM, Dolezal BA, M Drummond B, Han MK, Hansel NN, Helton K, Hoffman EA, Kaner RJ, Kanner RE, Krishnan JA, Lazarus SC, Martinez FJ, Ohar J, Ortega VE, Paine R, Peters SP, Reinhardt JM, Rennard S, Smith BM, Tashkin DP, Couper D, Cooper CB, Woodruff PG
Date Published2023 Aug 01
KeywordsCigarette Smoking, Disease Progression, Female, Follow-Up Studies, Forced Expiratory Volume, Humans, Longitudinal Studies, Lung, Lung Diseases, Male, Middle Aged, Pulmonary Disease, Chronic Obstructive, Respiratory Function Tests, Spirometry, Vital Capacity

IMPORTANCE: People who smoked cigarettes may experience respiratory symptoms without spirometric airflow obstruction. These individuals are typically excluded from chronic obstructive pulmonary disease (COPD) trials and lack evidence-based therapies.OBJECTIVE: To define the natural history of persons with tobacco exposure and preserved spirometry (TEPS) and symptoms (symptomatic TEPS).DESIGN, SETTING, AND PARTICIPANTS: SPIROMICS II was an extension of SPIROMICS I, a multicenter study of persons aged 40 to 80 years who smoked cigarettes (>20 pack-years) with or without COPD and controls without tobacco exposure or airflow obstruction. Participants were enrolled in SPIROMICS I and II from November 10, 2010, through July 31, 2015, and followed up through July 31, 2021.EXPOSURES: Participants in SPIROMICS I underwent spirometry, 6-minute walk distance testing, assessment of respiratory symptoms, and computed tomography of the chest at yearly visits for 3 to 4 years. Participants in SPIROMICS II had 1 additional in-person visit 5 to 7 years after enrollment in SPIROMICS I. Respiratory symptoms were assessed with the COPD Assessment Test (range, 0 to 40; higher scores indicate more severe symptoms). Participants with symptomatic TEPS had normal spirometry (postbronchodilator ratio of forced expiratory volume in the first second [FEV1] to forced vital capacity >0.70) and COPD Assessment Test scores of 10 or greater. Participants with asymptomatic TEPS had normal spirometry and COPD Assessment Test scores of less than 10. Patient-reported respiratory symptoms and exacerbations were assessed every 4 months via phone calls.MAIN OUTCOMES AND MEASURES: The primary outcome was assessment for accelerated decline in lung function (FEV1) in participants with symptomatic TEPS vs asymptomatic TEPS. Secondary outcomes included development of COPD defined by spirometry, respiratory symptoms, rates of respiratory exacerbations, and progression of computed tomographic-defined airway wall thickening or emphysema.RESULTS: Of 1397 study participants, 226 had symptomatic TEPS (mean age, 60.1 [SD, 9.8] years; 134 were women [59%]) and 269 had asymptomatic TEPS (mean age, 63.1 [SD, 9.1] years; 134 were women [50%]). At a median follow-up of 5.76 years, the decline in FEV1 was -31.3 mL/y for participants with symptomatic TEPS vs -38.8 mL/y for those with asymptomatic TEPS (between-group difference, -7.5 mL/y [95% CI, -16.6 to 1.6 mL/y]). The cumulative incidence of COPD was 33.0% among participants with symptomatic TEPS vs 31.6% among those with asymptomatic TEPS (hazard ratio, 1.05 [95% CI, 0.76 to 1.46]). Participants with symptomatic TEPS had significantly more respiratory exacerbations than those with asymptomatic TEPS (0.23 vs 0.08 exacerbations per person-year, respectively; rate ratio, 2.38 [95% CI, 1.71 to 3.31], P < .001).CONCLUSIONS AND RELEVANCE: Participants with symptomatic TEPS did not have accelerated rates of decline in FEV1 or increased incidence of COPD vs those with asymptomatic TEPS, but participants with symptomatic TEPS did experience significantly more respiratory exacerbations over a median follow-up of 5.8 years.

Alternate JournalJAMA
PubMed ID37526720
PubMed Central IDPMC10394572
Grant ListL30 HL134025 / HL / NHLBI NIH HHS / United States
U01 HL137880 / HL / NHLBI NIH HHS / United States
K24 HL137013 / HL / NHLBI NIH HHS / United States
U24 HL141762 / HL / NHLBI NIH HHS / United States
KL2 TR001882 / TR / NCATS NIH HHS / United States
F32 HL158222 / HL / NHLBI NIH HHS / United States
Manuscript Full Title: 
Longitudinal Follow-Up of Participants With Tobacco Exposure and Preserved Spirometry.
Manuscript Lead/Corresponding Author Affiliation: 
Clinical Center: San Francisco (University of California at San Francisco)
Manuscript Status: 
Published and Public