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Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function.
Han, MeiLan K; Ye, Wen; Wang, Di; White, Emily; Arjomandi, Mehrdad; Barjaktarevic, Igor Z; Brown, Stacey-Ann; Buhr, Russell G; Comellas, Alejandro P; Cooper, Christopher B; Criner, Gerard J; Dransfield, Mark T; Drescher, Frank; Folz, Rodney J; Hansel, Nadia N; Kalhan, Ravi; Kaner, Robert J; Kanner, Richard E; Krishnan, Jerry A; Lazarus, Stephen C; Maddipati, Veeranna; Martinez, Fernando J; Mathews, Anne; Meldrum, Catherine; McEvoy, Charlene; Nyunoya, Toru; Rogers, Linda; Stringer, William W; Wendt, Christine H; Wise, Robert A; Wisniewski, Stephen R; Sciurba, Frank C; Woodruff, Prescott G.
  • Han MK; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Ye W; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Wang D; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • White E; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Arjomandi M; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Barjaktarevic IZ; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Brown SA; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Buhr RG; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Comellas AP; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Cooper CB; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Criner GJ; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Dransfield MT; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Drescher F; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Folz RJ; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Hansel NN; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Kalhan R; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Kaner RJ; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Kanner RE; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Krishnan JA; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Lazarus SC; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Maddipati V; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Martinez FJ; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Mathews A; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Meldrum C; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • McEvoy C; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Nyunoya T; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Rogers L; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Stringer WW; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Wendt CH; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Wise RA; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Wisniewski SR; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Sciurba FC; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
  • Woodruff PG; From the Division of Pulmonary and Critical Care (M.K.H., C. Meldrum) and the School of Public Health (W.Y., D.W., E.W.), University of Michigan, Ann Arbor; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine (M.A., S.C.L., P.G.W.) and the Cardiovascular Research Institute (S.C.L.,
N Engl J Med ; 387(13): 1173-1184, 2022 09 29.
Article in English | MEDLINE | ID: covidwho-2050642
ABSTRACT

BACKGROUND:

Many persons with a history of smoking tobacco have clinically significant respiratory symptoms despite an absence of airflow obstruction as assessed by spirometry. They are often treated with medications for chronic obstructive pulmonary disease (COPD), but supporting evidence for this treatment is lacking.

METHODS:

We randomly assigned persons who had a tobacco-smoking history of at least 10 pack-years, respiratory symptoms as defined by a COPD Assessment Test score of at least 10 (scores range from 0 to 40, with higher scores indicating worse symptoms), and preserved lung function on spirometry (ratio of forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ≥0.70 and FVC ≥70% of the predicted value after bronchodilator use) to receive either indacaterol (27.5 µg) plus glycopyrrolate (15.6 µg) or placebo twice daily for 12 weeks. The primary outcome was at least a 4-point decrease (i.e., improvement) in the St. George's Respiratory Questionnaire (SGRQ) score (scores range from 0 to 100, with higher scores indicating worse health status) after 12 weeks without treatment failure (defined as an increase in lower respiratory symptoms treated with a long-acting inhaled bronchodilator, glucocorticoid, or antibiotic agent).

RESULTS:

A total of 535 participants underwent randomization. In the modified intention-to-treat population (471 participants), 128 of 227 participants (56.4%) in the treatment group and 144 of 244 (59.0%) in the placebo group had at least a 4-point decrease in the SGRQ score (difference, -2.6 percentage points; 95% confidence interval [CI], -11.6 to 6.3; adjusted odds ratio, 0.91; 95% CI, 0.60 to 1.37; P = 0.65). The mean change in the percent of predicted FEV1 was 2.48 percentage points (95% CI, 1.49 to 3.47) in the treatment group and -0.09 percentage points (95% CI, -1.06 to 0.89) in the placebo group, and the mean change in the inspiratory capacity was 0.12 liters (95% CI, 0.07 to 0.18) in the treatment group and 0.02 liters (95% CI, -0.03 to 0.08) in the placebo group. Four serious adverse events occurred in the treatment group, and 11 occurred in the placebo group; none were deemed potentially related to the treatment or placebo.

CONCLUSIONS:

Inhaled dual bronchodilator therapy did not decrease respiratory symptoms in symptomatic, tobacco-exposed persons with preserved lung function as assessed by spirometry. (Funded by the National Heart, Lung, and Blood Institute and others; RETHINC ClinicalTrials.gov number, NCT02867761.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Bronchodilator Agents / Pulmonary Disease, Chronic Obstructive Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Bronchodilator Agents / Pulmonary Disease, Chronic Obstructive Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article