Effects of L-arginine and Liposomial Vitamin C on Severe Copd Patients Undergoing Pulmonary Rehabilitation.
Launched by ISTITUTI CLINICI SCIENTIFICI MAUGERI SPA · May 28, 2024
Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether adding L-arginine and liposomal Vitamin C to a rehabilitation program can help patients with severe Chronic Obstructive Pulmonary Disease (COPD) and breathing difficulties. Researchers believe that these supplements might reduce fatigue and improve heart-related health in these patients, potentially making their overall treatment more effective. The trial is currently looking for participants between the ages of 40 and 90 who have COPD and are experiencing respiratory failure, meaning they struggle to get enough oxygen while breathing room air.
To join the trial, participants must not have taken any performance-enhancing supplements in the past two months and should not have severe lung or heart conditions that could affect their ability to take part. Those who enroll can expect to receive additional support during their pulmonary rehabilitation program, which focuses on improving breathing and overall health. It’s important for potential participants and their families to know that this study aims to find better ways to manage COPD and help improve the quality of life for patients dealing with this challenging condition.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • COPD patients of both sexes complicated by respiratory failure (PaO2 inferior to 60 mmHg while breathing room air)
- • aged between 40 and 90 years selected from the inpatient/outpatient population admitted to perform a PR program in 12 Italian rehabilitation hospitals.
- Exclusion criteria:
- • consuming any ergogenic supplement in the last 2 months;
- • severe acute exacerbations in the 3 months before enrolment;
- • clinical instability (pH inferior to 7.35, hemodynamic instability, tachypnea at rest);
- • lung restrictive diseases;
- • primitive pulmonary hypertension;
- • recent lung thromboembolic events;
- • orthopaedic clinical conditions interfering with exercise;
- • coronary heart disease;
- • cardiac failure with reduced ejection fraction;
- • major cardiac arrhythmias;
- • neuromuscular diseases;
- • mini mental state examination (MMSE) \<24;
- • any prior or current medical problem that would limit the subject participation
Trial Officials
mauro maniscalco
Principal Investigator
IRCCS Maugeri Telese
About Istituti Clinici Scientifici Maugeri Spa
Istituti Clinici Scientifici Maugeri S.p.A. is a prestigious Italian healthcare organization dedicated to advancing medical research and clinical practice. With a strong focus on patient-centered care, the institution integrates innovative clinical trials into its comprehensive services, fostering collaboration between researchers and healthcare professionals. Known for its commitment to high-quality standards and ethical practices, Istituti Clinici Scientifici Maugeri S.p.A. plays a pivotal role in the development of new therapies and treatment modalities, contributing significantly to the global medical community and enhancing patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Telese Terme, Benevento, Italy
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0