Improving Quality of Life and Daily Life Activities With Bioarginine in Patients With COPD

NARecruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

January 18, 2023

Primary Completion Date

December 31, 2023

Study Completion Date

January 31, 2024

Conditions
COPDDyspneaArgininemia
Interventions
DRUG

Arginine

During the first assessment the patients will be randomized to receive BioArginine C™ twice daily on top of chronic inhaled therapy or to continue their chronic Inhaled therapy plus placebo for 6 weeks. The main purpose is to compare changes in CRQ from baseline and after 6 weeks in the interventional arm compared with the control group in order to evaluate whether in symptomatic patients with COPD, daily bioarginine on top of chronic inhaled therapy can improve respiratory symptoms and dyspnea. The secondary objective of the study is to determine whether there is any correlation between improvement in respiratory symptoms and distance walked at the 6MWT and lung function parameters.

DRUG

Placebo

During the first assessment the patients will be randomized to receive BioArginine C™ twice daily on top of chronic inhaled therapy or to continue their chronic Inhaled therapy plus placebo for 6 weeks. The main purpose is to compare changes in CRQ from baseline and after 6 weeks in the interventional arm compared with the control group in order to evaluate whether in symptomatic patients with COPD, daily bioarginine on top of chronic inhaled therapy can improve respiratory symptoms and dyspnea. The secondary objective of the study is to determine whether there is any correlation between improvement in respiratory symptoms and distance walked at the 6MWT and lung function parameters.

Trial Locations (1)

20157

RECRUITING

L. Sacco Hospital, Milan

All Listed Sponsors
lead

University of Milan

OTHER