Targeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary Fibrosis
Abstract
The study team hypothesizes that intermittent (3 doses administered over 3 consecutive days in 3 consecutive weeks) oral administration of combination Dasatinib (100 mg/d) + Quercetin (1250 mg/d) will be safe and well tolerated in patients with IPF. Treatment with D+Q will result in reduced abundance of pro-inflammatory cells within subjects over baseline. Finally, the reduction in biomarkers of cellular pro-inflammatory state will be related to no change in functional and patient reported outcomes.
Conditions: Idiopathic Pulmonary Fibrosis (IPF).
Primary outcome: Percentage of pro-inflammatory expressing cells; Percentage of pro-inflammatory expressing cells; Blood Pressure; Blood Pressure; Blood Pressure; Weight; Weight; Weight; Heart Rate; Heart Rate; Heart Rate; CBC (complete blood count); CBC (complete blood count); Lipid Panel; Lipid Panel; HbA1c (glycated hemoglobin); HbA1c (glycated hemoglobin); CMP (comprehensive metabolic panel); CMP (comprehensive metabolic panel); Plasma hsCRP (high-sensitivity C-reactive protein); Plasma hsCRP (high-sensitivity C-reactive protein); Plasma IL-6 (inflammatory biomarker); Plasma IL-6 (inflammatory biomarker); Plasma IL-6R (inflammatory biomarker); Plasma IL-6R (inflammatory biomarker); Plasma PASP biomarkers (inflammatory biomarkers); Plasma PASP biomarkers (inflammatory biomarkers); p16INK4a biomarker (inflammatory biomarker); p16INK4a biomarker (inflammatory biomarker).
Enrollment: 26 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 26 participants or records.
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