Quality of life and dyspnoea in patients treated with bosentan for idiopathic pulmonary fibrosis (BUILD-1)

No therapy is known to improve health-related quality of life (HRQoL) or dyspnoea in patients with idiopathic pulmonary fibrosis. The present study investigated longitudinal changes in HRQoL and dyspnoea and explored the effects of bosentan on these end-points during the Bosentan Use in Interstitial Lung Disease (BUILD)-1 trial. In total, 154 subjects received oral bosentan (n = 71) or placebo (n = 83). Changes in HRQoL and dyspnoea from baseline to month (M) 6 and up to M12 were measured using the St George’s Respiratory Questionnaire (SGRQ), 36-item short-form health survey (SF-36), Transition Dyspnoea Index and Borg dyspnoea index. Overall, minimal changes occurred in measures of HRQoL and dyspnoea among placebo-treated subjects during the study. The effects of bosentan treatment on HRQoL and dyspnoea in the all-treated population were minimal. However, in the subset of subjects who had undergone surgical lung biopsy for diagnosis of idiopathic pulmonary fibrosis, treatment effects were observed up to M12 in the impact domain of the SGRQ and the physical functioning, general health and role emotional domains of the SF-36. HRQoL and dyspnoea changed minimally during the course of the present study. Observations from exploratory analyses suggested benefits of bosentan on HRQoL among patients who had undergone surgical lung biopsy for diagnosis, and they merit further investigation.

[1]  D. Lynch,et al.  BUILD-3: a randomized, controlled trial of bosentan in idiopathic pulmonary fibrosis. , 2011, American journal of respiratory and critical care medicine.

[2]  G. Raghu,et al.  BUILD-1: a randomized placebo-controlled trial of bosentan in idiopathic pulmonary fibrosis. , 2008, American journal of respiratory and critical care medicine.

[3]  K. Imanaka,et al.  Health-related quality of life in patients with idiopathic pulmonary fibrosis--cross-sectional and longitudinal study. , 2007, Internal medicine.

[4]  S. Kudoh,et al.  Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. , 2005, American journal of respiratory and critical care medicine.

[5]  Y. Kondoh,et al.  Health-related quality of life in patients with idiopathic pulmonary fibrosis. What is the main contributing factor? , 2005, Respiratory medicine.

[6]  G. Raghu,et al.  A placebo-controlled trial of interferon gamma-1b in patients with idiopathic pulmonary fibrosis. , 2004, The New England journal of medicine.

[7]  G. Guyatt,et al.  Evaluation of the minimal important difference for the feeling thermometer and the St. George's Respiratory Questionnaire in patients with chronic airflow obstruction. , 2003, Journal of clinical epidemiology.

[8]  D. Mahler,et al.  Minimal important difference of the transition dyspnoea index in a multinational clinical trial , 2003, European Respiratory Journal.

[9]  B. Alving,et al.  Update in Hematology , 2001, Annals of Internal Medicine.

[10]  J. Pearson,et al.  Fibroblast matrix gene expression and connective tissue remodeling: role of endothelin-1. , 2001, The Journal of investigative dermatology.

[11]  A. Pardo,et al.  Idiopathic Pulmonary Fibrosis: Prevailing and Evolving Hypotheses about Its Pathogenesis and Implications for Therapy , 2001, Annals of Internal Medicine.

[12]  L. Morales,et al.  The RAND-36 measure of health-related quality of life , 2001, Annals of medicine.

[13]  Arnold Simanowitz,et al.  international consensus statement , 2000 .

[14]  David A. Lynch,et al.  Idiopathic pulmonary fibrosis: Diagnosis and treatment: International Consensus Statement , 2000 .

[15]  K P Offord,et al.  Prognostic significance of histopathologic subsets in idiopathic pulmonary fibrosis. , 1998, American journal of respiratory and critical care medicine.

[16]  R. Michel,et al.  Increased endothelin-1 in bleomycin-induced pulmonary fibrosis and the effect of an endothelin receptor antagonist. , 1997, American journal of respiratory and critical care medicine.

[17]  C. Sherbourne,et al.  The MOS 36-Item Short-Form Health Survey (SF-36) , 1992 .

[18]  P. Jones,et al.  The St George's Respiratory Questionnaire. , 1991, Respiratory medicine.

[19]  C. Wells,et al.  The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. , 1984, Chest.

[20]  G. Borg Psychophysical bases of perceived exertion. , 1982, Medicine and science in sports and exercise.