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Table 1 Diagnostic Criteria of RELIEF Patient Categories (all to be fulfilled within each category)

From: Exploring efficacy and safety of oral Pirfenidone for progressive, non-IPF lung fibrosis (RELIEF) - a randomized, double-blind, placebo-controlled, parallel group, multi-center, phase II trial

Lung fibrosis associated with collagen / vascular diseases

• Diagnosis of progressive systemic sclerosis (PSS), rheumatoid arthritis (RA), Sjörgen’s syndrome, polymyositis/dermatomyositis on the basis of extrapulmonary symptoms and corresponding proof of auto-antibodies

• Reticular changes in HRCT and restrictive lung function pattern

• Absence of an alternative explanation for fibrotic lung disease

Fibrotic NSIP

• Histological diagnosis of a fibrotic NSIP pattern by open lung biopsy or cryobiopsy

• HRCT consistent with fibrotic NSIP

• Restrictive lung function pattern

• Absence of an alternative explanation for fibrotic lung disease, especially no clinical suspicion of CVD

Chronic Hypersensitivity Pneumonitis

• Previous or current respiratory symptoms (dyspnea, coughing) with a temporal or spatial relation to a causative antigen exposure

• Proof of precipitating antibody and/or lymphocytic alveolitis (>30%)

• HRCT consistent with chronic HP

• Restrictive lung function pattern

• Absence of an alternative explanation for fibrotic lung disease

Asbestos-induced lung fibrosis

• Existence of asbestos-specific pleural changes in HRCT (pleural plaques)

• Reticular changes in HRCT and restrictive lung function pattern

• History of asbestos exposure

• Absence of an alternative explanation for fibrotic lung disease

• Absence of extensive pleural plaques and/or effusion