Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Apr;151(4):813-820.
doi: 10.1016/j.chest.2016.11.052. Epub 2016 Dec 22.

Improved Cough and Cough-Specific Quality of Life in Patients Treated for Scleroderma-Related Interstitial Lung Disease: Results of Scleroderma Lung Study II

Donald P Tashkin  1 , Elizabeth R Volkmann  2 , Chi-Hong Tseng  2 , Michael D Roth  2 , Dinesh Khanna  3 , Daniel E Furst  2 , Philip J Clements  2 , Arthur Theodore  4 , Suzanne Kafaja  2 , Grace Hyun Kim  5 , Jonathan Goldin  5 , Edgar Ariolla  6 , Robert M Elashoff  7
Affiliations
Randomized Controlled Trial

Improved Cough and Cough-Specific Quality of Life in Patients Treated for Scleroderma-Related Interstitial Lung Disease: Results of Scleroderma Lung Study II

Donald P Tashkin et al. Chest. 2017 Apr.

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 quality of life (QoL), and response to therapy for SSc-ILD have not been well studied.

Methods: We investigated frequent cough (FC) in patients with SSc-ILD (N = 142) enrolled in the Scleroderma Lung Study II, a randomized controlled trial comparing mycophenolate mofetil (MMF) and oral cyclophosphamide (CYC) as treatments for interstitial lung disease (ILD). We determined the impact of FC on QoL (Leicester Cough Questionnaire [LCQ]), evaluated the 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 high-resolution CT, had a lower diffusing capacity for carbon monoxide, and reported more GERD symptoms than did 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 indicate 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: FC 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 over a 2-year course of therapy. Frequent cough might serve as a useful surrogate marker of treatment response in SSc-ILD trials.

Trial registry: ClinicalTrials.gov; No.: NCT00883129; URL: www.clinicaltrials.gov.

Keywords: cough; health-related quality of life; immunosuppressive therapy; interstitial lung disease; scleroderma.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Changes in the proportion of patients with frequent cough over the 24-month course of the trial by treatment arm based on logistic regression.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Theodore A.C., Tseng C.-H., Li N., Elashoff R.M., Tashkin D.P. Correlation of cough with disease activity and treatment with cyclophosphamide in scleroderma interstitial lung disease. Chest. 2012;142(3):614–621. - PMC - PubMed
    1. Tashkin D.P., Elashoff R., Clements F.J., Scleroderma Lung Study Research Group Cyclophosphamide versus placebo in scleroderma lung disease. N Engl J Med. 2006;354(25):2655–2666. - PubMed
    1. Tashkin D.P., Elashoff R., Clements P.J. Effects of 1-year treatment with cyclophosphamide on outcomes at 2 years in scleroderma lung disease. Am J Respir Crit Care Med. 2007;176(10):1026–1034. - PMC - PubMed
    1. Tashkin D.P., Roth M.D., Clements P.J. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease: Scleroderma Lung Study II (SLS-II), a double-blind, parallel group, randomized controlled trial. Lancet Respir Med. 2016;4(9):708–719. - PMC - PubMed
    1. Subcommittee for Scleroderma Criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee Preliminary criteria for the classification of systemic sclerosis (scleroderma) Arthritis Rheumatol. 1980;23(5):581–590. - PubMed

Publication types

MeSH terms

Associated data