Effect of add-on Doxofylline on Lung Function in Stable COPD

Starting soon · Phase 4

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

It is a phase IV, prospective, interventional, single blind, randomized, crossover trial in which the investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg bid, in add-on to maximal inhalation therapy, in clinically stable COPD patients.

Key facts

Study ID

NCT04238221

Run by

University of Milan

People needed

78

Starts

2026-12-01

Expected to finish

2027-12-30

Last updated by the study team

2026-04-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• L. Sacco Hospital — Milan, Italy

Full record on ClinicalTrials.gov

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