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Original Research |

Improved cough and cough-specific quality of life in patients treated for scleroderma-related interstitial lung disease (SSc-ILD): Results of Scleroderma Lung Study II

Donald P. Tashkin, MD; Elizabeth R. Volkmann, MD; Chi-Hong Tseng, PhD; Michael D. Roth, MD; Dinesh Khanna, MD; Daniel E. Furst, MD; Philip J. Clements, MD; Arthur Theodore, MD; Suzanne Kafaja, MD; Grace Hyun Kim, PhD; Jonathan Goldin, MD; Edgar Ariolla, PharmD; Robert M. Elashoff, PhD
Author and Funding Information

Summary of conflict of interest statements: DPT served as a consultant to EMD Serono; MDR received a contract for study drug supply from Roche in support of SLS II; DK is funded by NIH/NIAMS (K24AR063120), received grant support from Bayer, Bristol-Meyer-Squibb (BMS), Roche/Genentech and Pfizer and served as a consultant to Actelion, BMS, Corbus, Roche/Genentech, GlaxoSmithKlein, Sanofi-Aventis and EMD Serono; DEF received grant support from Amgen, BMS, Novartis, Pfizer and Roche/Genentech and served as a consultant to AbbVie, Amgen, BMS, Cytori, Janssen, Novartis, Pfizer, Roche/Genetech and UCB pharma. C-HT, PC, AT, SK, GHK, JG and RME report no conflict of interest

Funded by the NHLBI (R01 HL089758 and R01 GK089901)

Trial registry: ClinicalTrials.gov; No.: NCT00883129

1David Geffen School of Medicine at UCLA, Los Angeles, CA

2University of Michigan Medical School, Ann Arbor, MI

3Boston University School of Medicine, Boston, MA

Corresponding author: Donald P. Tashkin, MD Department of Medicine David Geffen School of Medicine at UCLA 10833 Le Conte Ave. Los Angeles, CA 90095 USA


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016. doi:10.1016/j.chest.2016.11.052
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Abstract

Background  Cough is a common symptom of scleroderma-related interstitial lung disease (SSc-ILD), but its relationship to other characteristics of SSc-ILD, impact on cough-specific QoL and response to therapy for SSc-ILD have not been well studied.

Methods  We investigated frequent cough (FC) in SSc-ILD patients (N=142) enrolled in Scleroderma Lung Study II, a randomized controlled trial comparing mycophenolate mofetil (MMF) and oral cyclophosphamide (CYC) as treatments for ILD. We determined the impact of FC on QoL (Leicester Cough Questionnaire [LCQ]), evaluated change in FC in response to treatment for SSc-ILD, and examined the relationship between gastroesophageal reflux disease (GERD) and cough during the trial.

Results  Study participants who reported FC at baseline (61.3%) reported significantly more dyspnea, exhibited more extensive ILD on HRCT, had a lower diffusing capacity for carbon monoxide (DLCO) and reported more GERD symptoms than those without FC. Cough-specific QoL was modestly impaired in patients with FC (total LCQ score 15.4±3.7; normal range 3-21, higher scores indicating worse QoL). The proportion of patients with FC at baseline declined by 44% and 41% over 2 years in the CYC and MMF treatment arms, respectively, and this decline was significantly related to changes in GERD and ILD severity.

Conclusions  Frequent cough occurs commonly in SSc-ILD, correlates with both the presence and severity of GERD and ILD at baseline and declines in parallel with improvements in both ILD and GERD during a 2-year course of therapy. Frequent cough might serve as a useful surrogate marker of treatment response in SSc-ILD trials.


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