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

Sponsor
University of Milan
Study ID
NCT04238221
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 23, 2020
Start date
Dec 1, 2026
Status verified
Apr 2026
Primary completion
Dec 1, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Doxofylline+inhalation therapy
    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
  • Experimental: Inhalation therapy
    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

Primary Outcome Measure

Difference in changes in FEV1 after 4 weeks of treatment [ Time Frame: 4-8 weeks ]

Central Contacts

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