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New pill could boost breathing in COPD patients already on inhalers

NCT ID NCT04238221

Disease control 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the drug doxofylline to standard inhaler therapy can improve lung function in people with stable COPD. 78 participants will take doxofylline or a placebo for 4 weeks, then switch. The main goal is to see if doxofylline increases the amount of air they can exhale in one second (FEV1).

What this could mean

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

Active substance
doxofylline (Ansimar)
What this could lead to
If it works, this could offer a new add-on option to help COPD patients breathe better when inhalers alone aren't enough.
What could go wrong
This is a small, early-phase trial with only 78 people over 4 weeks. Results may not apply to all COPD patients, and doxofylline may cause side effects like nausea or headache.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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: * COPD diagnosis for at least 6 months, according to current European Respiratory Society guidelines * baseline FEV1 ≤ 80% of predicted value * active or former smokers with smoking history ≥ 10 pack-years * patients chronically treated with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonists (LABA), in association with or without an inhaled corticosteroid (ICS) * clinically stable disease for 6 months. Exclusion Criteria: * previous or current diagnosis of bronchial asthma * previous lung volume reduction through surgery or endobronchial valves * inability to perform respiratory function tests according to international standards, or contraindications to perform 6-minute walking test * known allergy or intolerance to doxofylline * current or potential pregnancy * mini-Mental test \<21 * congestive heart failure NYHA III or IV * recent (\<6 months) myocardial infarction * unstable arrhythmias * chronic hypotension * active peptic ulcer * severe liver disease * active neoplasia * history of drug or alcohol abuse.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

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

Chronic obstructive pulmonary disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • L. Sacco Hospital

    Milan, 20157, Italy

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