PURPOSE: Virtually every IPF patient suffers from dyspnea. However, the exact subjective perception of this important symptom over time is unknown and needs assessment by measurements/scores.
METHODS: We examined dyspnea scores gathered prospectively from the Baseline (BDI), Transition (TDI), and Borg (measured after 6-min.walk test) Dyspnea Indexes, and results from lung physiology testing over time from 83well defined IPF subjects randomized to the placebo arm of a multi-national trial of bosentan for the treatment of IPF. Borg Dyspnea Index is scored from 10 (severe impairment) to 0 (unimpairment). TDI is scored from −3 (major deterioration) to +3 (major improvement) compared to baseline. Minimum clinically important difference in TDI scores between two time points is 1 unit.
RESULTS: Age: 65.1+9.1yrs (mean ± SD); 76% subjects were male; 92% were white. Median exposure: 54.4 weeks. Mean duration of IPF symptoms was 2.5yrs. Mean time from diagnosis to randomization was 1.1yrs. FVC% declined from 69.5+12.6 (baseline) to 61.8+18.4 at End of Period 1 (EP1; month 12 or earlier if premature discontinuation). DLCO% predicted, 41.4+9.5 (baseline) declined to 35.6+13.2 at EP1. At study baseline, according to BDI, subjects perceived themselves as having moderate degree (compared to the average person) of dyspnea and being moderately impaired by dyspnea (median score=2.0 for each of the three BDI domains: Functional Impairment, Magnitude of Task, and Magnitude of Effort). Over study period, subjects perceived major dyspnea deterioration according to TDI. Median total scores (Interquartile range) from the domains of the BDI and TDI (Month 6 and EP1) were: 7.0 (5.0, 8.0); −1.0 (−4.0,0.0); and −3.0 (−6.0, 0.0) respectively. Borg Dyspnea Index: subjects reported slight dyspnea (study baseline), increasing to moderate by 6 months and remaining moderate at EP1.
CONCLUSION: On average, subjects with moderate IPF rated themselves as having slight to moderate dyspnea at baseline. Over a median of 54.4 weeks, patients experienced significantly worsening dyspnea.
CLINICAL IMPLICATIONS: Dyspnea can be measured by standard scores utilized for assessment of dyspnea in this population.
DISCLOSURE: Jeff Swigris, Consultant fee, speaker bureau, advisory committee, etc. Jeff Swigris, Juergen Behr, Kevin Brown, Ron du Bois, Talmadge King Jr., Ganesh Raghu have been remunerated consultants for Actelion Pharmaceuticals Ltd, the manufacturers of bosentan; Product/procedure/technique that is considered research and is NOT yet approved for any purpose, Bosentan is not approved for use in IPF.