An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002)
Gotfried MH, Girod CE, Antin-Ozerkis D, Burgess T, Strombom I, Stauffer JL, Kirchgaessler KU, Padilla ML. An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002). Pulmonary Therapy 2018, 4: 59-71. PMID: 32026243, PMCID: PMC6967037, DOI: 10.1007/s41030-018-0053-y.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsIdiopathic pulmonary fibrosisPatient exposure yearsSerious treatment-emergent adverse eventsPulmonary fibrosisIPF progressionFrequent treatment-emergent adverse eventsUpper respiratory tract infectionSafety of pirfenidoneUse of pirfenidoneOpen-label studyPhase II studyGastroesophageal reflux diseaseNew safety signalsRespiratory tract infectionsOverall incidence rateLong-term safetyCumulative total exposureConcomitant prednisoneOpen labelReflux diseaseAdverse eventsII studyMaintenance doseMost patients