Improving daily life for COPD patients with bioarginine
Improving Quality of Life and Daily Life Activities With Bioarginine in Patients With COPD: a Multicenter, Randomized, Controlled, Proof of Concept Study
This study is testing if taking arginine supplements can help improve daily life and symptoms for people with COPD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05412160 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of arginine supplementation on the quality of life and daily activities of patients with Chronic Obstructive Pulmonary Disease (COPD). It is based on the premise that arginase inhibition or supplementation may improve nitric oxide availability, potentially alleviating symptoms associated with COPD. Participants will receive either arginine or a placebo to assess the impact on their condition. The study aims to provide insights into how enhancing L-arginine metabolism can benefit COPD patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 40 years old with a significant smoking history and moderate to severe COPD.
Not a fit: Patients with recent exacerbations, interstitial lung disease, or those unable to perform physical tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life and daily functioning for patients with COPD.
How similar studies have performed: While the approach of arginine supplementation is promising, it remains to be seen if this specific methodology has been tested successfully in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- L. Sacco Hospital — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Pierachille Santus, PhD, MD, Prof
- Email: pierachille.santus@unimi.it
- Phone: 0039 0239042801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.