RT Journal Article SR Electronic T1 S137 The natural history of IPF in patients eligible for clinical trials vs patients not eligible JF Thorax JO Thorax FD BMJ Publishing Group Ltd and British Thoracic Society SP A63 OP A63 DO 10.1136/thoraxjnl-2011-201054b.137 VO 66 IS Suppl 4 A1 Macfarlane, P A1 Hoo, Z H A1 Hammersley, R L S A1 McErlean, C M A1 Anpalakhan, S A1 Stewart, G A A1 Wallace, W A A1 Murchison, J T A1 Simpson, A J A1 Hirani, N YR 2011 UL http://thorax.bmj.com/content/66/Suppl_4/A63.1.abstract AB Recruitment to clinical trials is a key objective in the management of IPF. For phase 3 trials, the inclusion and exclusion criteria are stringent. It is not known if the natural history of IPF in patients eligible for clinical trials differs from that in non-eligible patients.Aims To determine the natural history of IPF in patients eligible for phase 3 trials vs those not eligibleMethods Since 1/1/2002, all patients with IPF presenting to the Edinburgh Royal Infirmary lung fibrosis clinic have been recruited prospectively to a database. The diagnosis of IPF was made by multi-disciplinary consensus after integration of clinical, HRCT and pathological data, based on ATS/ERS criteria. Management and follow-up was by standardised protocol. IPF-directed therapy, including corticosteroids, azathioprine and anti-oxidants, was considered only in advanced disease, acute exacerbation or in those who exhibited pre-specified fall in lung function. Patients were grouped into those eligible for phase 3 clinical trials and those ineligible, based on the major inclusion/exclusion criteria used in a recently published study (CAPACITY, Lancet 2011 377;1760–1769).Results Of 199 consecutively presenting patients with IPF, 61 (31%) were eligible for a phase 3 trial. The proportion of males in the eligible and ineligible groups was similar, but eligible patients were younger (68 vs 74 yrs, p<0.0001), comprised fewer individuals with >20 pack/year smoking history (50% vs 65%, p=0.057), had lower % predicted VC (82.6 vs 95.8 p=0.0003) and higher % predicted TLCO (56.6 vs 51.9, p=0.07). Eligible patients had less % emphysema on HRCT scoring compared to non-eligible patients (0.74% vs 6% p<0.0001). The 3yr-survival of eligible and ineligible patients were not significantly different (Abstract S137 figure 1 74% vs 63%, p=0.3). Event-free survival, defined as time to death or =10% fall in VC or =15% fall in TLCO or acute exacerbation of IPF or hospital admission with respiratory illness, was not significantly different between eligible and ineligible groups, such that in both groups 40% and 60% experienced a progression-defining event by 12 -and 24-months respectively.Abstract S137 Figure 1 IPF survival.Conclusions Trial ineligible patients are demographically and phenotypically different from eligible patients, but have identical mortality and progression-free survival. These data have important implications for translation of trial data to clinical practice and for IPF trial design.