A Phase II Clinical Trial of Low Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis.

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A Phase II Clinical Trial of Low Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis.

Chest. 2017 Oct 31;:

Authors: Rosas IO, Goldberg HJ, Collard HR, El-Chemaly S, Flaherty K, Hunninghake GM, Lasky JA, Lederer DJ, Machado R, Martinez FJ, Maurer R, Teller D, Noth I, Peters E, Raghu G, Garcia JGN, Choi AMK

Abstract
BACKGROUND: Pre-clinical studies have demonstrated that low-dose carbon monoxide (CO) can abrogate experimental lung fibrosis. To test the therapeutic role of inhaled CO, we designed a clinical study in patients with idiopathic pulmonary fibrosis (IPF).
METHODS: We conducted a multicenter, phase IIa, double-blinded, sham-controlled, clinical trial. IPF patients were randomized to treatment with inhaled CO at 100 - 200 parts per million (ppm) or to inhaled 21% oxygen for 2 hours daily, twice weekly, for 12 weeks. The primary study endpoint was the difference in change in metalloproteinase-7 (MMP7) serum concentration following 12 weeks of treatment. Secondary endpoints included pulmonary function test measures, six-minute walk distance, rates of adverse events, acute exacerbation, hospitalization and death and quality of life measures.
FINDINGS: Fifty-eight subjects were randomized to treatment with inhaled CO (n = 29) or placebo (n = 29). Despite modest increases in CO blood levels, the change in MMP7 concentrations following 12-weeks of treatment did not significantly differ between the study arms (MMP7 difference at week 12 was -0.90 ng/ml, 95% CI -4.18 to 2.38 ng/ml). No differences were observed in physiologic measures, incidence of acute exacerbations, hospitalization, death or patient-reported outcomes. Importantly no differences in distribution of adverse events were noted between the treatment arms.
INTERPRETATION: Inhaled CO is well tolerated and can be safely administered to IPF patients in the ambulatory setting; however inhaled CO did not result in significant changes in study endpoints. Our findings support testing the efficacy of inhaled therapies in future IPF clinical trials.
FUNDING: NHLBI Grant HL105371.

PMID: 29100885 [PubMed - as supplied by publisher]

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