Tests doxofylline added to inhalers for stable chronic lung disease
Tests doxofylline added to inhalers in adults with stable COPD.
Plain-language title generated from the registry record
Registry title: Effect of add-on Doxofylline on Lung Function in Stable COPD
Key facts
- Where
- Milan, ItalySee the site
- Phase
- Phase 4
Where in Italy
- L. Sacco HospitalMilan, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Milan
- Trial code
- NCT04238221
- Record updated
- 29 April 2026
- Original description
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.Read full original descriptionShow less
Effect of Doxofylline on Bronchial Obstruction, in add-on to Maximal Inhalation Therapy, in Clinically Stable COPD Patients.
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.
Inclusion: 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: previous or current diagnosis of bronchial asthma; previous lung volume reduction through surgery or endobronchial valves; 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; 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.