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

NCT04238221 | Not Yet Recruiting Phase 4

• 1 other identifier: 01-PNSNP-2020
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Bronchodilator; Pulmonary Function Test; Doxofylline; Methylxanthines; 6-minute walk test; FEV1

Outcome Measures

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.

  4-8 weeks

Secondary Outcomes (13)

• Change in FEV1 60' after drug administration

  60 minutes

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

  4-8 weeks

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

  4-8 weeks

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

  4-8 weeks

• Changes in resting and effort dyspnea 180' after drug administration

  4-8 weeks

Study Arms (2)

Doxofylline+inhalation therapy

EXPERIMENTAL

4-week treatment with doxofylline tablets 400 mg bid in addition to maximal inhalation therapy, followed by 4-week treatment of maximal inhalation therapy only

Drug: Doxofylline

Inhalation therapy

EXPERIMENTAL

4-week treatment with maximal inhalation therapy only, followed by 4-week treatment with doxofylline tablets 400 mg bid in addition to maximal inhalation therapy

Drug: Doxofylline

Interventions

Doxofylline DRUG

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

Also known as: Ansimar

Doxofylline+inhalation therapy; Inhalation therapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

L. Sacco Hospital

Milan, 20157, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

doxofylline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierachille Santus, MD, PhD

CONTACT

0239043801; pierachille.santus@unimi.it

Dejan Radovanovic, MD

CONTACT

dejan.radovanovic@unimi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization, drug administration and patient training will be performed by an operator not involved in patients' recruitment and in the data collection and analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Diseases, Head of the Respiratory Disease Unit, L. Sacco University Hospital, Milan, Italy

Model Details: Phase 4, single center, prospective, interventional, randomized, single blind, crossover

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 23, 2020
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)