A Pilot Randomized Trial of Transdermal Nicotine for Pulmonary Sarcoidosis.
Administration, Cutaneous
Adult
Disease Progression
Double-Blind Method
Female
Forced Expiratory Volume
Humans
Lung
/ diagnostic imaging
Male
Middle Aged
Nicotine
/ therapeutic use
Nicotinic Agonists
/ therapeutic use
Pilot Projects
Sarcoidosis, Pulmonary
/ diagnostic imaging
Tobacco Use Cessation Devices
Tomography, X-Ray Computed
Vital Capacity
FVC
fatigue
granuloma
human
interstitial lung disease
nicotinic receptor
randomized controlled trial
Journal
Chest
ISSN: 1931-3543
Titre abrégé: Chest
Pays: United States
ID NLM: 0231335
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
received:
04
01
2021
revised:
16
04
2021
accepted:
07
05
2021
pubmed:
25
5
2021
medline:
11
1
2022
entrez:
24
5
2021
Statut:
ppublish
Résumé
Tobacco smoking is associated with a reduced risk of developing sarcoidosis, and we previously reported that nicotine normalizes immune responses to environmental antigens in patients with active pulmonary sarcoidosis. The effects of nicotine on the progression of pulmonary sarcoidosis are unknown. Is nicotine treatment well tolerated, and will it improve lung function in patients with active pulmonary sarcoidosis? With local institutional review board approval, a randomized, double-blind, controlled pilot trial was conducted of daily nicotine transdermal patch treatment (21 mg daily) or placebo patch use for 24 weeks. The Ohio State University Wexner Medical Center and Cleveland Clinic enrolled 50 consecutive subjects aged ≥ 18 years with active pulmonary sarcoidosis, based on symptoms (ie, dyspnea, cough) and objective radiographic evidence of infiltrates consistent with nonfibrotic lung disease. Each study group was compared at 26 weeks based on repeated measures of FVC, FEV Nicotine treatment was associated with a clinically significant, approximately 2.1% (70 mL) improvement in FVC from baseline to 26 weeks. FVC decreased by a similar amount (2.2%) in the placebo group, with a net increase of 140 mL (95% CI, 10-260) when comparing nicotine vs placebo groups at 26 weeks. FEV Nicotine treatment was well tolerated in patients with active pulmonary sarcoidosis, and the preliminary findings of this pilot study suggest that it may reduce disease progression, based on FVC. ClinicalTrials.gov; No.: NCT02265874; URL: www.clinicaltrials.gov.
Sections du résumé
BACKGROUND
Tobacco smoking is associated with a reduced risk of developing sarcoidosis, and we previously reported that nicotine normalizes immune responses to environmental antigens in patients with active pulmonary sarcoidosis. The effects of nicotine on the progression of pulmonary sarcoidosis are unknown.
RESEARCH QUESTION
Is nicotine treatment well tolerated, and will it improve lung function in patients with active pulmonary sarcoidosis?
STUDY DESIGN AND METHODS
With local institutional review board approval, a randomized, double-blind, controlled pilot trial was conducted of daily nicotine transdermal patch treatment (21 mg daily) or placebo patch use for 24 weeks. The Ohio State University Wexner Medical Center and Cleveland Clinic enrolled 50 consecutive subjects aged ≥ 18 years with active pulmonary sarcoidosis, based on symptoms (ie, dyspnea, cough) and objective radiographic evidence of infiltrates consistent with nonfibrotic lung disease. Each study group was compared at 26 weeks based on repeated measures of FVC, FEV
RESULTS
Nicotine treatment was associated with a clinically significant, approximately 2.1% (70 mL) improvement in FVC from baseline to 26 weeks. FVC decreased by a similar amount (2.2%) in the placebo group, with a net increase of 140 mL (95% CI, 10-260) when comparing nicotine vs placebo groups at 26 weeks. FEV
INTERPRETATION
Nicotine treatment was well tolerated in patients with active pulmonary sarcoidosis, and the preliminary findings of this pilot study suggest that it may reduce disease progression, based on FVC.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov; No.: NCT02265874; URL: www.clinicaltrials.gov.
Identifiants
pubmed: 34029565
pii: S0012-3692(21)00962-4
doi: 10.1016/j.chest.2021.05.031
pmc: PMC8546242
pii:
doi:
Substances chimiques
Nicotinic Agonists
0
Nicotine
6M3C89ZY6R
Banques de données
ClinicalTrials.gov
['NCT02265874']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1340-1349Subventions
Organisme : NHLBI NIH HHS
ID : R34 HL123586
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001070
Pays : United States
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
Références
Thorax. 1988 Jul;43(7):516-24
pubmed: 2850637
Lung. 2015 Oct;193(5):701-8
pubmed: 26286208
Chest. 2009 Aug;136(2):526-535
pubmed: 19395578
Respir Med. 2015 Apr;109(4):526-31
pubmed: 25698652
Am J Respir Crit Care Med. 2017 Nov 3;197(5):644-652
pubmed: 29099620
Am Rev Respir Dis. 1981 Jun;123(6):659-64
pubmed: 7271065
Eur Respir J. 2020 Sep 3;56(3):
pubmed: 32366492
Contemp Clin Trials Commun. 2020 Oct 07;20:100669
pubmed: 33089005
Am J Respir Crit Care Med. 2006 Oct 1;174(7):795-802
pubmed: 16840744
Clin Ther. 2000 Sep;22(9):1121-45
pubmed: 11048909
F1000Res. 2019 Dec 30;8:
pubmed: 31942239
Gastroenterol Res Pract. 2008;2008:237185
pubmed: 18795117
Lancet. 1990 Jan 20;335(8682):149-53
pubmed: 1967441
Chest. 1985 Nov;88(5):687-90
pubmed: 4053710
Respir Med. 2018 May;138S:S31-S37
pubmed: 29137908
Clin Exp Immunol. 2020 Feb;199(2):230-243
pubmed: 31631328
Eur Respir Rev. 2020 Mar 20;29(155):
pubmed: 32198218
Chest. 2002 Jan;121(1):24-31
pubmed: 11796428
Am J Respir Crit Care Med. 2004 Apr 15;169(8):903-9
pubmed: 14701707
PLoS Med. 2020 Dec 3;17(12):e1003432
pubmed: 33270649
Chest. 2012 Dec;142(6):1589-1597
pubmed: 22628487
Inflammation. 2019 Oct;42(5):1666-1679
pubmed: 31236857
J Psychosom Res. 2003 Apr;54(4):345-52
pubmed: 12670612
Am J Respir Crit Care Med. 2015 Apr 1;191(7):786-95
pubmed: 25594886
Chest. 2004 Mar;125(3):997-1004
pubmed: 15006960
Am J Respir Crit Care Med. 2011 Dec 15;184(12):1382-9
pubmed: 21940789
Am J Transl Res. 2017 Mar 15;9(3):971-985
pubmed: 28386326
Chest. 2013 Feb 1;143(2):461-470
pubmed: 22878868
J Neurophysiol. 2011 Sep;106(3):1191-202
pubmed: 21653710
Am J Respir Crit Care Med. 2020 Apr 15;201(8):e26-e51
pubmed: 32293205
Sarcoidosis Vasc Diffuse Lung Dis. 2005 Jun;22(2):147-53
pubmed: 16053031
Am J Respir Crit Care Med. 1998 Aug;158(2):412-7
pubmed: 9700114
Am J Respir Crit Care Med. 2004 Dec 15;170(12):1324-30
pubmed: 15347561
Curr Opin Pulm Med. 2012 May;18(3):233-40
pubmed: 22388583
Sarcoidosis Vasc Diffuse Lung Dis. 2017;34(1):2-17
pubmed: 32476819