Open label case-control study to
assess Pidotimod efficacy in Non CF
Bronchiectasis Disease: a pilot study
Maria D'Amato, Francesca Simioli, Maria Martino, Nunzia Sorrentino, Mariasole Porzio, Anna Agnese Stanziola, Antonio Molino, Mauro MormileEuropean Respiratory Journal 2017 50: PA4063; DOI: 10.1183/1393003.congress-2017.PA4063
Abstract
Background: Diagnosis and management of non CF bronchiectasis has been largely empirical and therapies other than antibiotics are subject of relatively few controlled clinical trials.
Pidotimod is a synthetic dipeptide molecule with immunomodulatory activity on both innate and adaptive responses.
Aim: To evaluate the effectiveness of pidotimod in reducing respiratory infections in Non CF Bronchiectasis Disease patients
Methods: Patients selected were 20 adults affected from nCF Bronchiectasis in ≥2 lobes, history of frequent bronchial infections (≥4 in the last year) without obstructive airflow limitation. They were randomized to receive Pidotimod 800 mg OD for 20 days monthly (Group A) or nothing (Group B) for 6 months.
All patients underwent spirometry, FeNO measurement, assessment of exacerbations at baseline (T0), 3 months (T3), 6 months (T6).
Results: At T3 and T6 FeNO significantly improved in Group A (T3 Δ -52,57 + 7,21% (p≤0,001); T6 Δ = -57,20 + 7,43 % (p≤0,001) but worsened in Group B at T6 (Δ = +41,57 + 18,77 % (p≤0,01). No difference was observed in FVC, FEV1 and IC. At T6 there was a significant decrease of exacerbation rate in Group A compared to Group B (≤1 vs ≥2; p=0.0003).
Conclusions: This study suggests that pidotimod may be able of preventing recurrent respiratory infections in adult Non CF Bronchiectasis Disease. Pidotimod may contribute to reduce lower airway inflammation as assessed by FeNO measurement.
