Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization
Status:
Completed
Trial end date:
2017-11-30
Target enrollment:
Participant gender:
Summary
Background: COPD exacerbations add considerably to patients' burden because they: (1) cause
frequent hospital admissions and relapses or readmissions, (2) contribute directly to the
death of many patients, either during hospitalization or shortly thereafter, (3) cause
patients significant stress, prolonged physical discomfort, disability and dramatically
reduced quality of life, (4) consume the majority of the resources available to manage this
chronic condition, (5) frequently progress to a severe stage warranting hospitalization
before any abortive treatment is instituted, and (6) may hasten the progressive loss of lung
function, a steady decline that is a cardinal feature of COPD itself. Hence, investigations
of new therapies to treat COPD patients who are hospitalized with a severe exacerbation are
desperately needed.
Objective: To test the feasibility of roflumilast to decrease all cause readmission and
mortality 180 days after hospitalization for acute COPD exacerbation.
Methods: Parallel-group, prospective, randomized, double blind, placebo-controlled trial of
roflumilast 500 ug daily vs. placebo in approximately 100 hospitalized AECOPD patients.
Inclusion Criteria. Primary diagnosis of AECOPD; admission to the hospital <12 hours; patient
age >40, < 80 years old; cigarette smoking > 10 pack-years. Exclusion Criteria. Prior
diagnosis or high suspicion for asthma; pulmonary edema, pneumonia, interstitial lung disease
or significant bronchiectasis; intubated and mechanically ventilated at the time of
evaluation; active liver disease, or transaminase elevations (> 3xULN); history of heavy
ethanol use; history of suicidal behavior ≤ 2 years or suicidal ideation ≤ 6 months prior to
enrollment; pregnant or lactating females. Those on the following excluded medications: P450
inducers and CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2
simultaneously