PMID- 37057088
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240323
IS  - 2312-0541 (Print)
IS  - 2312-0541 (Electronic)
IS  - 2312-0541 (Linking)
VI  - 9
IP  - 2
DP  - 2023 Mar
TI  - Efficacy and tolerability of zinc acetate for treatment of chronic refractory 
      cough: pilot randomised futility trial.
LID - 00678-2022 [pii]
LID - 10.1183/23120541.00678-2022 [doi]
AB  - BACKGROUND: Cough is the most reported symptom in the United States, with chronic 
      refractory cough representing significant morbidity to patients. Zinc acetate may 
      have beneficial effects in the cough reflex pathway. We sought to assess the 
      safety and efficacy of zinc acetate in the management of chronic refractory 
      cough. STUDY DESIGN AND METHODS: This was a randomised, placebo-controlled, 
      parallel-design pilot trial of individuals with chronic refractory cough. The 
      effects of 6 weeks of zinc acetate versus placebo on quality of life and symptoms 
      as measured by the Cough Quality-of-Life Questionnaire (CQLQ), Leicester Cough 
      Questionnaire (LCQ), cough visual analogue score (C-VAS) and Global Assessment of 
      Change in Cough (GACC) scores were evaluated. A futility analysis plan with a 
      one-sided 80% confidence interval was used to compare treatment effect to 
      published minimum clinically important differences (MCID) for each outcome. 
      RESULTS: 34 participants, 17 in each group, were enrolled and randomised. 
      Participants were primarily white females with moderate-severe cough. 
      Participants assigned to zinc acetate had a significant increase in serum zinc 
      levels after 6 weeks, while those assigned to placebo did not. Both groups showed 
      improvement in CQLQ, LCQ, C-VAS and GACC scores, but the treatment effects of 
      zinc acetate versus placebo were small with confidence intervals that did not 
      include the MCIDs. INTERPRETATION: We observed no benefit of zinc therapy over 
      placebo on cough symptoms or quality of life and conclude that larger trials of 
      zinc for chronic cough are not warranted.
CI  - Copyright (c)The authors 2023.
FAU - Balasubramanian, Aparna
AU  - Balasubramanian A
AUID- ORCID: 0000-0002-1854-6672
AD  - The Johns Hopkins University, School of Medicine, Pulmonary and Critical Care 
      Medicine, Baltimore, MD, USA.
FAU - Holbrook, Janet T
AU  - Holbrook JT
AD  - The Johns Hopkins University, Bloomberg School of Public Health, Epidemiology, 
      Baltimore, MD, USA.
FAU - Canning, Brendan J
AU  - Canning BJ
AUID- ORCID: 0000-0003-4197-5560
AD  - The Johns Hopkins University, School of Medicine, Pulmonary and Critical Care 
      Medicine, Baltimore, MD, USA.
FAU - Que, Loretta G
AU  - Que LG
AUID- ORCID: 0000-0001-9188-9244
AD  - Duke University School of Medicine, Pulmonary, Allergy, and Critical Care 
      Medicine, Durham, NC, USA.
FAU - Castro, Mario
AU  - Castro M
AD  - Kansas University Medical Center, Pulmonary, Critical Care and Sleep Medicine, 
      Kansas City, KA, USA.
FAU - Make, Barry J
AU  - Make BJ
AUID- ORCID: 0000-0003-4349-8745
AD  - National Jewish Health, Division of Pulmonary, Critical Care and Sleep Medicine, 
      Denver, CO, USA.
FAU - Rogers, Linda
AU  - Rogers L
AD  - Icahn School of Medicine at Mount Sinai, Pulmonary, Critical Care and Sleep 
      Medicine, New York, NY, USA.
FAU - Busk, Michael F
AU  - Busk MF
AD  - St Vincent Health, Wellness and Preventive Care Institute, Indianapolis, IN, USA.
FAU - Rea, Alexis
AU  - Rea A
AD  - The Johns Hopkins University, Bloomberg School of Public Health, Epidemiology, 
      Baltimore, MD, USA.
FAU - McCook-Veal, Ashley A
AU  - McCook-Veal AA
AUID- ORCID: 0000-0001-5368-4977
AD  - The Johns Hopkins University, Bloomberg School of Public Health, Epidemiology, 
      Baltimore, MD, USA.
FAU - He, Jiaxian
AU  - He J
AD  - The Johns Hopkins University, Bloomberg School of Public Health, Epidemiology, 
      Baltimore, MD, USA.
FAU - McCormack, Meredith C
AU  - McCormack MC
AD  - The Johns Hopkins University, School of Medicine, Pulmonary and Critical Care 
      Medicine, Baltimore, MD, USA.
FAU - Wise, Robert A
AU  - Wise RA
AUID- ORCID: 0000-0002-8353-2349
AD  - The Johns Hopkins University, School of Medicine, Pulmonary and Critical Care 
      Medicine, Baltimore, MD, USA.
LA  - eng
GR  - K23 HL153778/HL/NHLBI NIH HHS/United States
GR  - UL1 TR004419/TR/NCATS NIH HHS/United States
PT  - Journal Article
DEP - 20230411
PL  - England
TA  - ERJ Open Res
JT  - ERJ open research
JID - 101671641
PMC - PMC10086688
COIS- Conflict of interest: M. Castro reports grant funding from the National 
      Institutes of Health, American Lung Association and the Patient-Centered Outcomes 
      Research Institute, pharmaceutical grant funding from AstraZeneca, GSK, Novartis, 
      Pulmatrix, Sanofi-Aventis, Shionogi, is a consultant for Genentech, Teva, 
      Sanofi-Aventis, Merck, Novartis, a speaker for for Amgen, AstraZeneca, Genentech, 
      GSK, Regeneron, Sanofi-Aventis, Teva, and receives royalties from Elsevier. 
      Conflict of interest: Authors A. Balasubramanian, J.T. Holbrook, B.J. Canning, 
      L.G. Que, B.J. Make, L. Rogers, M.F. Busk, A. Rea, A.A. McCook-Veal, J. He, M.C. 
      McCormack report no conflicts of interest related to this manuscript. Conflict of 
      interest: R.A. Wise reports personal fees for consultation from Merck relevant to 
      the content of this manuscript.
EDAT- 2023/04/15 06:00
MHDA- 2023/04/15 06:01
PMCR- 2023/04/11
CRDT- 2023/04/14 02:37
PHST- 2022/12/06 00:00 [received]
PHST- 2023/01/13 00:00 [accepted]
PHST- 2023/04/15 06:01 [medline]
PHST- 2023/04/14 02:37 [entrez]
PHST- 2023/04/15 06:00 [pubmed]
PHST- 2023/04/11 00:00 [pmc-release]
AID - 00678-2022 [pii]
AID - 10.1183/23120541.00678-2022 [doi]
PST - epublish
SO  - ERJ Open Res. 2023 Apr 11;9(2):00678-2022. doi: 10.1183/23120541.00678-2022. 
      eCollection 2023 Mar.