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

Launched by UNIVERSITY OF MILAN · Jun 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a supplement called BioArginine can help improve the daily life and respiratory symptoms of patients with Chronic Obstructive Pulmonary Disease (COPD). The trial will involve people who are over 40 years old and have a history of smoking, along with some specific lung function measurements that indicate their COPD is moderate to severe. Participants will be randomly assigned to receive either BioArginine or a placebo (a harmless dummy treatment) for six weeks, while continuing their usual inhaled medications.

During the study, participants can expect to answer questions about their breathing and daily activities, and they will also take part in a walking test to see how far they can go in six minutes. This trial aims to find out if BioArginine can help reduce feelings of breathlessness and improve overall quality of life for people with COPD. It's important to note that individuals with certain conditions, like asthma or lung infections in the recent past, will not be eligible to participate in the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \> 40 years old
• • Smoke history \>10 pack years (PYs)
• • Forced expiratory volume (FEV1 70-40% predicted)
• • COPD Assessment Test score \>= 10
• • Stable Inhaled therapy in the three months prior to study enrollment
• Exclusion Criteria:
• • Exacerbations in the three months prior to study enrolment
• • Dementia and inability to perform study test bundles
• • Interstitial lung disease
• • History of asthma
• • Patients unable to perform a 6MWT or necessitating a walker to ambulate
• • Long term oxygen therapy (excluding patients on nocturnal O2 therapy)
• • Patients enrolled In pulmonary rehabilitation programs during the study or that have completed a pulmonary rehabilitation program in the 6 months before study enrollment