AzTrials
AzTrials

COPDNCT05412160

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

A study testing Arginine in people with COPD and Dyspnea, run by University of Milan at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Different studies have suggested that COPD is associated with elevated alveolar NO and increased expression of NOS2 in alveolar walls, small airway epithelium and vascular smooth muscle. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD, Dyspnea, Argininemia
What is being tested?
Arginine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
1 siteItaly
Study dates
18 Jan 2023to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • L. Sacco Hospital

    Milan, Italy, 20157

Other trials in Italy

About this study

Official title: Improving Quality of Life and Daily Life Activities With Bioarginine in Patients With COPD: a Multicenter, Randomized, Controlled, Proof of Concept Study

Different studies have suggested that COPD is associated with elevated alveolar NO and increased expression of NOS2 in alveolar walls, small airway epithelium and vascular smooth muscle. Furthermore, arginase activity in COPD is shown to correlate inversely with total NO metabolite in sputum and with pre- and post- bronchodilator FEV1; at the same time ADMA levels in serum is shown to be correlated with airway resistance and ADMA in COPD airways was documented to be able to shift the L-arginine metabolism towards the arginase pathway. As demonstrated in a guinea pig model, the arginase inhibition can shift the L-ornitine: L-citrulline ratio towards L-citrulline, preventing neutrophilia, mucus hypersecretion and collagen synthesis. Thus, increasing substrate availability for NOS by arginase inhibition or supplementation of L-arginine or L-citrulline or a combination thereof, may represent a window of opportunity in patients with COPD.

The present study was constructed in order to investigate as a primary objective whether in symptomatic patients with COPD, daily bioarginine on top of chronic inhaled therapy can improve patients' respiratory symptoms and dyspnea during daily life activities. 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. In order to do so, the investigators designed a multi center, interventional, prospective, randomized, controlled vs placebo, proof of concept study: COPD patients will be randomized to receive BioArginine twice daily on top of chronic inhaled therapy or to continue their chronic Inhaled therapy plus placebo for 6 weeks. In order to evaluate the impact on respiratory symptoms and dyspnea the CRQ (Chronic Respiratory disease Questionnaire) and the LCADL (London Chest Activities of daily Living) Scale, as well as the 6MWT, will be used.

Being tested
Arginine, Placebo
Keywords
COPD, Arginine
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Dyspnea, Hyperargininemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ArginineDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT05412160
Study groupRoleWhat they receive
ARM A - BioArginine receiversExperimentalPatients will be randomized to receive BioArginine C™ twice daily on top of usual chronic inhaled therapy
Receives: Drug: Arginine
ARM B - placebo receiversPlacebo comparatorPatients will be randomized to receive placebo twice daily on top of usual chronic inhaled therapy
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare changes in CRQ from baseline and after 6 weeks in the interventional arm compared with the control group

    Patients will undergo the assesment of the Chronic Respitatory Qestionnaire at the time of study erollment and after 6 weeks of treatment with bioarginine or placebo.

    The questionnaire contains 20 questions which can be divided into four domains:

    • Dyspnoea (5 questions), The dyspnoea domain is "individualised" which means that it is made up of five activities chosen by a patient to cause the greatest shortness of breath. The patient then rates the dyspnoea on these self-selected activities during subsequent administrations of the CRQ.
    • Fatigue (4 questions),
    • Emotional functioning (7 questions),
    • Mastery (4 questions).
    • Answers can be scored on a seven point scale ranging from 1 which indicates maximum impairment to 7 which indicates no impairment. The results are expressed as the mean score for each domain and the mean overall score.
    • The minimally important difference was found to be an improvement (or deterioration) of 0.5

    Measured: 6 weeks

Secondary outcomes (3)

  1. To compare changes in LCADL from baseline and after 6 weeks in the interventional arm compared with the control group

    Patients will undergo the assesment of the London Chest Activities of Daily Living at the time of study erollment and after 6 weeks of treatment with bioarginine or placebo.

    The LCADL scale is a 15-item tool that measures the effect of dyspnea on routine daily activities. The LCADL provides a total score from 0 to 75 points with higher scores indicating greater limitations. Domain scores include personal care (0-20), domestic activities (0-30), physical activity (0-10), and leisure (0-15). The minimal detectable change (MDC) for the total score is 3.88 or approximately 4 points, 0.89 for personal care, 2.60 for domestic activities, 0.44 for physical activities, and 0.58 for leisure.

    The minimal detectable change (MDC) for the total score is 3.88 or approximately 4 points, 0.89 for personal care, 2.60 for domestic activities, 0.44 for physical activities, and 0.58 for leisure.

    Measured: 6 weeks

  2. To compare changes in the distance covered during the 6MWT from baseline and after 6 weeks in the interventional arm compared with the control group

    Patiens will undergo the Six Minutes Walking Test at study enrolment and after 6 weeks of treatment with bioarginine or placebo.

    The 6MWT will be conducted in room air conditions, in a corridor of 30 meters of lenght while the patients has being monitored with a pulsoxymeter that will register the peripheral oxygen saturation and heart right during the test. At the beginning and at the end of the test, Borg Dyspnea Scale (0-10 points), blood pressure and vitals will be registered. The patient will be asked to walk with a sutained pace for six minutes and the distance covered will be recorded. The mMCID of the 6MWT has been definied of 40 meter.

    Measured: 6 weeks

  3. To compare changes in the dyspnea domain of the CRQ from baseline and after 6 weeks in the interventional arm compared with the control group

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start18 Jan 2023
  3. Primary completion1 Dec 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412160
Sponsor's protocol ID
BIOCOPD2022
Status last verified
Jun 2025
First submitted
6 Jun 2022
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.

    PubMed 2691207

  • Bisca GW, Proenca M, Salomao A, Hernandes NA, Pitta F. Minimal detectable change of the London chest activity of daily living scale in patients with COPD. J Cardiopulm Rehabil Prev. 2014 May-Jun;34(3):213-6. doi: 10.1097/HCR.0000000000000047.

    PubMed 24531202

  • Garrod R, Bestall JC, Paul EA, Wedzicha JA, Jones PW. Development and validation of a standardized measure of activity of daily living in patients with severe COPD: the London Chest Activity of Daily Living scale (LCADL). Respir Med. 2000 Jun;94(6):589-96. doi: 10.1053/rmed.2000.0786.

    PubMed 10921765

Questions about this trial

What is this clinical trial studying?

A study testing Arginine in people with COPD and Dyspnea, run by University of Milan at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare changes in CRQ from baseline and after 6 weeks in the interventional arm compared with the control group (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412160, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in