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

Study acronym: EDAI
StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary completion date: Oct 30, 2020 to Dec 1, 2027
    • Start date: Sep 1, 2020 to Dec 1, 2026
    • Study completion date: Nov 30, 2020 to Dec 30, 2027
    v5
  2. Notable Primary completion date: Apr 30, 2020 to Oct 30, 2020
    • Start date: Mar 1, 2020 to Sep 1, 2020
    • Study completion date: May 31, 2020 to Nov 30, 2020
    v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Notable Primary endpoint revisedv2 Show 4 more changesShow less
    • Primary completion date: Mar 31, 2020 to Apr 30, 2020
    • Interventions: Doxofylline (Drug), Placebo oral tablet (Drug) to Doxofylline (Drug)
    • Secondary endpoints: 11 to 13
    • Study description expanded, about 182 words
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,119 trials monitored
See 34 trials at risk
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.
Trial Details
NCT Number NCT04238221
Lead Sponsor University of Milan
Conditions
(from sponsor)
Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov