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

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00071461.

Figures

Figure 1. Median SGRQ component scores at baseline, M6 and up to M12 in placebo-treated patients in the all-treated population

Data in brackets are interquartile ranges. HRQL, quality of life; SGRQ, St George's Respiratory Questionnaire.

Figure 2. Median SF-36 domain scores at baseline, M6 and up to M12 in placebo-treated patients in the all-treated population

Data in brackets are interquartile ranges. HRQL, quality of life; SF-36, 36-item short-form instrument.

Figure 3A. Median changes from baseline in component and total SGRQ scores in the SLB subset up to month 12

Treatment effects are illustrated where P

Figure 3B. Median changes from baseline in domains of the SF-36 in the SLB subset up to month 12

Data in brackets are interquartile ranges. Treatment effects are illustrated where P