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

• Status: Not yet recruiting
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Treatments: Doxofylline; Theophylline

Criteria

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.