Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Temple University
Study ID
NCT01973998
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    PDE4 inhibitor
  • Placebo — DRUG
    Inactive substance.

Study Details

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

Key Dates

Start date
Nov 30, 2013
Status verified
Feb 2020
Primary completion
Nov 10, 2017
Completion
Nov 30, 2017

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast
    500 ug tablet daily for 180 days
  • Placebo Comparator: Placebo
    Placebo 1 tablet daily x 180 days

Primary Outcome Measure

Time to All-cause Mortality or Re-hospitalization During the 180 Days Post-randomization. [ Time Frame: 180 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Temple University HospitalPhiladelphiaPennsylvania19140-

Find similar trials in Philadelphia, PA

By condition
COPD
By specialty
PulmonologyLung disease
By research site
Temple University Hospital· Philadelphia, PA

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