Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function.
Adrenergic beta-2 Receptor Agonists
/ therapeutic use
Anti-Bacterial Agents
/ therapeutic use
Bronchodilator Agents
/ therapeutic use
Forced Expiratory Volume
Glucocorticoids
/ therapeutic use
Glycopyrrolate
Humans
Lung
Pulmonary Disease, Chronic Obstructive
/ drug therapy
Nicotiana
/ adverse effects
Treatment Outcome
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
29 09 2022
29 09 2022
Historique:
pubmed:
7
9
2022
medline:
1
10
2022
entrez:
6
9
2022
Statut:
ppublish
Résumé
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. 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 [FEV 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 FEV 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.).
Sections du résumé
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 [FEV
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 FEV
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.).
Identifiants
pubmed: 36066078
doi: 10.1056/NEJMoa2204752
pmc: PMC9741866
mid: NIHMS1852968
doi:
Substances chimiques
Adrenergic beta-2 Receptor Agonists
0
Anti-Bacterial Agents
0
Bronchodilator Agents
0
Glucocorticoids
0
Glycopyrrolate
V92SO9WP2I
Banques de données
ClinicalTrials.gov
['NCT02867761']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1173-1184Subventions
Organisme : NHLBI NIH HHS
ID : U01 HL128952
Pays : United States
Organisme : NIEHS NIH HHS
ID : P30 ES005605
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001422
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01 HL137880
Pays : United States
Organisme : NHLBI NIH HHS
ID : HL128954
Pays : United States
Organisme : CSRD VA
ID : I01 CX000105
Pays : United States
Organisme : NCATS NIH HHS
ID : KL2 TR001882
Pays : United States
Organisme : NHLBI NIH HHS
ID : HL128952
Pays : United States
Organisme : NHLBI NIH HHS
ID : K24 HL138188
Pays : United States
Organisme : CSRD VA
ID : I01 CX001048
Pays : United States
Organisme : NHLBI NIH HHS
ID : K24 HL137013
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA014236
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL149719
Pays : United States
Investigateurs
Stephen Lazarus
(S)
Prescott Woodruff
(P)
Stephanie Christenson
(S)
Nirav Bhakta
(N)
Michael Peters
(M)
Christopher Quan
(C)
Julian Silva
(J)
John Fahy
(J)
Scott Fields
(S)
Sundos Yasin
(S)
Gerard Criner
(G)
Joanna Beros
(J)
Parag Desai
(P)
Puja Dubal
(P)
Sean Duffy
(S)
Dolores Fehrle
(D)
Ezinne Ilogu
(E)
Victor Kim
(V)
Douglas Lampo
(D)
Nathaniel Marchetti
(N)
Francine McGonagle
(F)
Jenna Murray
(J)
Erin Narewski
(E)
Shubhra Srivastava-Malhotra
(S)
Lauren Miller
(L)
Abimola Samuel Akinseye Kolapo
(AS)
Erica Anderson
(E)
Matthew Banker
(M)
Surya Bhatt
(S)
Mark Dransfield
(M)
Stephanie Ford
(S)
Meenakshi Gupta
(M)
Necole Harris
(N)
Renita Holmes
(R)
Keenya Mathews
(K)
Casondra Matthews
(C)
Trisha Parehh
(T)
Siddharth Patel
(S)
James Wells
(J)
Elizabeth Westfall
(E)
Erika Coleman
(E)
James Davis
(J)
Heather Kuehn
(H)
Catherine Lavenburg
(C)
Markedia Mason
(M)
Anne Mathews
(A)
Eli Morgan
(E)
Roy Pleasants
(R)
Loretta Que
(L)
Timothy Scialla
(T)
Marguerite Thoma
(M)
Joan Wilson
(J)
Cheryl Clare
(C)
Cassandra Foster
(C)
Laura Grammar
(L)
Nadia Hansel
(N)
Samiha Khan
(S)
Wendy Lorizio
(W)
Nirupama Putcha
(N)
Zarqa Tariq
(Z)
Leonard Turnier
(L)
Donna Virgil
(D)
Arabelis Wally
(A)
Robert Wise
(R)
Allison Aase
(A)
Megan Campbell
(M)
Doug Decarolis
(D)
Miranda Deconcini
(M)
Aimee Hamel
(A)
Ken Kunisaki
(K)
Mara Satter
(M)
JoAnn Tallman
(J)
Mary Walquist
(M)
Chris Wendt
(C)
Charlene McEvoy
(C)
Pamela Neuenfeldt
(P)
Cheryl Sasse
(C)
Allison Spradley
(A)
Sara Toov
(S)
Natalie Woodruff
(N)
Alyssa Frederick
(A)
Vanessa Garcia
(V)
Khalilah Gates
(K)
James Hilao
(J)
Jenny Hixon
(J)
Vantasia Joe
(V)
Ravi Kalhan
(R)
Diane Larsen
(D)
Eunice Lee
(E)
Jane Regalado
(J)
Paul Reyfman
(P)
Allison Rogowski
(A)
Sharon Rosenberg
(S)
Lakshmi Sivarajan
(L)
Lewis Smith
(L)
Cindy Zhao
(C)
Alejandra Comellas
(A)
Pyridon Fortis
(P)
Fozia Ghafoor
(F)
Theresa Hobbs
(T)
Kristine Johnson
(K)
Melissa Jones
(M)
Joel Kline
(J)
Molly Martin
(M)
Thomas Sardone
(T)
Wendy Slaughter
(W)
Kim Sprenger
(K)
Igor Barjaktarevic
(I)
Kayla Brown
(K)
Russell Buhr
(R)
Marissa Dembek
(M)
Brian Jung
(B)
Maggie Lindenbaum
(M)
Mary Ann Macaso
(MA)
Roslynn McGill
(R)
Fran Rosen
(F)
Miguel Villarreal
(M)
Marietta Wadley
(M)
Christopher Cooper
(C)
Rachael Aletti
(R)
Lianne De La Cruz
(L)
Natella Fridman
(N)
Robert Kaner
(R)
Paul Kim
(P)
Jamuna Krishnan
(J)
Victoria Lesina
(V)
Matthew Marcelino
(M)
Alicia Morris
(A)
Keyla Ordonez
(K)
Elizabeth Peters
(E)
Antonio Rivera Lopez
(A)
Lisa Torres
(L)
William Zhang
(W)
Daniel Arminavage
(D)
Jessica Bon Field
(J)
Mary Bryner
(M)
Divay Chandra
(D)
Jared Chiarchiaro
(J)
Paula Consolaro
(P)
Bryson Custer
(B)
Kathryn Gazarik
(K)
Vera Louchmanov
(V)
Christina Ledezma
(C)
Rhonda Lincoln
(R)
Toru Nyunoya
(T)
Michael O'Brien
(M)
Craig Riley
(C)
Elizabeth Stempkowski
(E)
Robert Wilson
(R)
Diana Zaldonis
(D)
Robert Calmelat
(R)
Richard Casaburi
(R)
Deborah Cavanaugh
(D)
Leticia Diaz
(L)
Teresita Endoso
(T)
Robert Gruhn
(R)
Renee Indelicato
(R)
Caren Lopez-Garcia
(C)
Hannah Mansky
(H)
Janos Porszasz
(J)
Martha Prieto
(M)
April Soviano
(A)
William Stringer
(W)
Roxanne Tanoviceanu
(R)
Miriam Urrutia
(M)
Ian Anastasia
(I)
Gretchen Bautista
(G)
Erica Blount
(E)
Crystal Cutlip
(C)
Michael Ferrera
(M)
Robert Finney
(R)
Briana Hamber
(B)
Mary Kay Hamby
(MK)
MeiLan Han
(M)
Suiyuan Huang
(S)
Muhammad Ishtiaq
(M)
Jordan Jahnke
(J)
Shijing Jia
(S)
Karen Jones
(K)
Brooke Kilyanek
(B)
Wassim Labaki
(W)
Tina Lucas
(T)
Lauren Mackenzie
(L)
Cheryl Majors
(C)
Jennifer Mawby
(J)
Nichole McLaughlin
(N)
Catherine Meldrum
(C)
Zachary Pawlikowski
(Z)
Denise Propes
(D)
Kelly Rysso
(K)
Margaret Salisbury
(M)
Helen Tamer
(H)
Xueting Tao
(X)
Liujian Zhao
(L)
Nina Bracken
(N)
Jennifer Buenrostro
(J)
Lauren Castro
(L)
David Chan
(D)
David De La Torre-Dorado
(D)
Julie DeLisa
(J)
Alvin Godina
(A)
Wendy Hasse
(W)
Sai Illendula
(S)
Jerry Krishnan
(J)
Stephanie LaBedz
(S)
Melissa Morales-Perez
(M)
Lourdes Norwick
(L)
Michael Pacini
(M)
Hetvi Patel
(H)
Kyle Potter
(K)
Valentin Prieto-Centurion
(V)
Ai-Yui Tan
(AY)
Jissell Torres
(J)
Margie Villareal
(M)
Jennison Cull
(J)
Jenice Herrera
(J)
Ryan Johnson
(R)
Richard Kanner
(R)
JennaLyn Mayeux
(J)
Newsha Sedghi
(N)
Martin Villeagas
(M)
Yorusaliem Abrham
(Y)
Mehrdad Arjomandi
(M)
Jennifer Cheuk
(J)
Elena Gochez
(E)
Henry Leung
(H)
Melissa Nishihama
(M)
Lemlem Weldemichael
(L)
Elizabeth Babcock
(E)
Sarah Beaudry
(S)
Joanne Burgess
(J)
Peter Delong
(P)
Frank Drescher
(F)
Cathy Lombardo
(C)
Michelle Mann
(M)
Macgregor Montano
(M)
Samuel Rosa
(S)
Wanda Rowe
(W)
Victoria Smith
(V)
Deelan Ayhan
(D)
Stacey Ann Brown
(SA)
Chelsea Chung
(C)
Ivy Cohen
(I)
Michele Cohen
(M)
Naja Daniels
(N)
Ciara Guzman
(C)
Nicole Lewis
(N)
Stephanie Pagan
(S)
Elizabeth Puig
(E)
Linda Rogers
(L)
Joadelin Tejada
(J)
Diana Valerio
(D)
Alice Wang
(A)
Michael Banchy
(M)
Toula Bensitel
(T)
Eileen Chen
(E)
Rodney Folz
(R)
Kim Fussell
(K)
Deborah Kaminsky
(D)
Dennis Kramarz
(D)
Coleen Lofters
(C)
Maroun Matta
(M)
Jhalu Mireuk
(J)
Audrey Parham
(A)
John Peterson
(J)
Rebecca Raine
(R)
Libby Schubert
(L)
Hillary Sedlacek
(H)
George Solich
(G)
Benjamin Tepfenhart
(B)
Michelle Williamson
(M)
Xiuhua Yuan
(X)
Matthew Bean
(M)
Konnor Edwards
(K)
Veranna Maddipati
(V)
Anagha Malur
(A)
Arjun Mohan
(A)
Nicole Powers
(N)
Ian Stroud
(I)
Monali Warule
(M)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2022 Massachusetts Medical Society.
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