Effect of add-on Doxofylline on Lung Function in Stable COPD
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Milan
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Doxofylline
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov