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

NCT01973998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-03-12

Study results available
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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

Conditions

Interventions

DRUG

Roflumilast

PDE4 inhibitor

DRUG

Placebo

Inactive substance.

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Temple University

    lead OTHER

Principal Investigators

  • Gerard J Criner, MD · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-11-10
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973998 on ClinicalTrials.gov