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Simple supplement could ease COPD breathlessness

NCT ID NCT05412160

Symptom relief Sponsor: University of Milan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether taking a daily arginine supplement (Bioarginine) for 6 weeks can improve breathing and daily activities in people with COPD. 153 participants were randomly assigned to receive the supplement or a placebo on top of their usual inhaled medications. The goal was to see if the supplement could reduce shortness of breath and improve quality of life, as measured by questionnaires and a walking test.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bioarginine (arginine supplement)
What this could lead to
If it works, this could offer a simple, daily supplement to help people with COPD breathe easier and do daily activities with less shortness of breath.
What could go wrong
This is a small, early proof-of-concept study, not a large definitive trial. The supplement may show no meaningful benefit over placebo, and results may not apply to all COPD patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

153 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

arginase deficiency chronic obstructive pulmonary disease COPD, severe early onset Dyspnea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Argininemia COPD Dyspnea

Contacts and locations

Locations

  • L. Sacco Hospital

    Milan, Italy, 20157, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.