NCT04238221Not yet recruitingPhase 4
Effect of add-on Doxofylline on Lung Function in Stable COPD
Effect of Doxofylline on Bronchial Obstruction, in add-on to Maximal Inhalation Therapy, in Clinically Stable COPD Patients.
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 14 Jan 2020
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- University of Milan
- Diseases
- COPD
- NCT number
- NCT04238221
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 78
- From 1 Dec 2026 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous or current diagnosis of bronchial asthma
- previous lung volume reduction through surgery or endobronchial valves
Other illness
- known allergy or intolerance to doxofylline
- congestive heart failure NYHA III or IV
- recent (\<6 months) myocardial infarction
- unstable arrhythmias
- active peptic ulcer
- severe liver disease
- history of drug or alcohol abuse.
Other
- inability to perform respiratory function tests according to international standards, or contraindications to perform 6-minute walking test
- current or potential pregnancy
- mini-Mental test \<21
- chronic hypotension
- active neoplasia
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| L. Sacco Hospital Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.