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

ConditionChronic Obstructive Pulmonary Disease
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Doxofylline

    Drug

    Patients will receive a 4-week treatment with doxofylline 400 mg bid, in addition to their chronic usual inhalation therapy.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Doxofylline+inhalation therapyExperimental treatment 1 intervention
Group B: Inhalation therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Difference in changes in FEV1 after 4 weeks of treatment

Difference between changes in the Forced Expiratory Volume in one second (FEV1) measured at baseline and the FEV1 after 4 weeks of treatment with doxofylline in addition to inhalation therapy, measured 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the FEV1 measured at baseline and the FEV1 after 4 weeks of treatment with inhalation therapy only, measured 30 minutes before the morning dose of inhalation therapy.

Time frame
4-8 weeks

Secondary outcomes

1

Change in FEV1 60' after drug administration

Changes in the Forced Expiratory Volume in one second (FEV1) measured at baseline and the FEV1 measured 60 minutes after the first dose of doxofylline plus inhalation therapy.

Time frame
60 minutes
2

Difference in changes in distance covered in 6-minute walking test after 4 weeks of treatment

Difference between changes in the distance covered in the 6-minute walking test (6-MWT) performed at baseline and the distance covered in 6-MWT performed after 4 weeks of treatment with doxofylline in addition to inhalation therapy, 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the distance covered in the 6-MWT performed at baseline and the 6-MWT performed after 4 weeks of treatment with inhalation therapy alone, 30 minutes before the morning dose of inhalation therapy.

Time frame
4-8 weeks
3

Changes in distance covered in 6-minute walking test 180' after drug administration

Change in the distance covered in the 6-minute walking test (6-MWT) performed at baseline and the distance covered in 6-MWT performed after 4 weeks of treatment with doxofylline in addition to inhalation therapy, 180 minutes after the morning dose of doxofylline

Time frame
4-8 weeks
4

Difference in changes in resting and effort dyspnea after 4 weeks of treatment

Difference between changes in the modified Borg dyspnea scale assessed before and after the 6-minute walking test (6-MWT) performed at baseline and the modified Borg dyspnea scale assessed before and after the 6-MWT performed after 4 weeks of treatment with doxofylline in addition to inhalation therapy, 30 minutes before the morning dose of doxofylline plus inhalation therapy, and changes in the modified Borg dyspnea scale assessed before and after the 6-MWT performed at baseline and the modified Borg dyspnea scale assessed before and after the 6-MWT performed after 4 weeks of treatment with inhalation therapy alone, 30 minutes before the morning dose of inhalation therapy. Modified Borg dyspnea scale is used to rate difficulty of breathing and ranges from 0 (absence of dyspnea) to 10 (maximum dyspnea).

Time frame
4-8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Milan

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: