Journal article
Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function
The New England journal of medicine, Vol.387(13), pp.1173-1184
09/29/2022
DOI: 10.1056/NEJMoa2204752
PMCID: PMC9741866
PMID: 36066078
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 intentionto-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.
Details
- Title: Subtitle
- Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function
- Creators
- MeiLan K. Han - University of California, San FranciscoWen Ye - University of California, San FranciscoDi Wang - University of California, San FranciscoEmily White - University of California, San FranciscoMehrdad Arjomandi - University of California, San FranciscoIgor Z. Barjaktarevic - University of California, San FranciscoStacey-Ann Brown - University of California, San FranciscoRussell G. Buhr - University of California, San FranciscoAlejandro P. Comellas - University of California, San FranciscoChristopher B. Cooper - University of California, San FranciscoGerard J. Criner - University of California, San FranciscoMark T. Dransfield - University of California, San FranciscoFrank Drescher - University of California, San FranciscoRodney J. Folz - University of California, San FranciscoNadia N. Hansel - University of California, San FranciscoRavi KalhanRobert J. Kaner - University of California, San FranciscoRichard E. Kanner - University of California, San FranciscoJerry A. Krishnan - University of California, San FranciscoStephen C. Lazarus - University of California, San FranciscoVeeranna Maddipati - University of California, San FranciscoFernando J. Martinez - University of California, San FranciscoAnne Mathews - University of California, San FranciscoCatherine Meldrum - University of California, San FranciscoCharlene McEvoy - University of California, San FranciscoToru Nyunoya - University of California, San FranciscoLinda Rogers - University of California, San FranciscoWilliam W. Stringer - University of California, San FranciscoChristine H. Wendt - University of California, San FranciscoRobert A. Wise - University of California, San FranciscoStephen R. Wisniewski - University of California, San FranciscoFrank C. Sciurba - University of California, San FranciscoPrescott G. Woodruff - University of California, San FranciscoRETHINC Study Group
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.387(13), pp.1173-1184
- DOI
- 10.1056/NEJMoa2204752
- PMID
- 36066078
- PMCID
- PMC9741866
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Grant note
- DOI: 10.13039/100000050, name: National Heart, Lung, and Blood Institute, award: HL128952, HL128954; DOI: 10.13039/100000098, name: NIH Clinical Center, award: K24HL137013, K24HL138188, K24HL140108, KL2TR001882; DOI: 10.13039/100008184, name: COPD Foundation
- Language
- English
- Date published
- 09/29/2022
- Academic Unit
- Pulmonary, Critical Care, and Occupational Medicine; ICTS; Internal Medicine
- Record Identifier
- 9984359662902771
Metrics
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