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

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ClinicalTrials.gov Identifier: NCT01973998
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Gerard Criner, Temple University

Brief 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


Condition or disease Intervention/treatment Phase
COPD Drug: Roflumilast Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Roflumilast in Hospitalized COPD on Mortality and Re-hospitalization
Study Start Date : November 2013
Actual Primary Completion Date : November 10, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Arm Intervention/treatment
Experimental: Roflumilast
500 ug tablet daily for 180 days
Drug: Roflumilast
PDE4 inhibitor
Other Name: Daliresp

Placebo Comparator: Placebo
Placebo 1 tablet daily x 180 days
Drug: Placebo
Inactive substance.
Other Name: Inactive substance




Primary Outcome Measures :
  1. time to all-cause mortality or re-hospitalization during the 180 days post-randomization. [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. respiratory death or respiratory re-hospitalization [ Time Frame: 180 ]
    respiratory death or respiratory re-hospitalization during the 180 days post-randomization; rate of death or readmission during the 30 days post-discharge; treatment failure (see definition below); change in health status, FEV1 (forced expiratory volume at one second, and dyspnea during the 180 days post-randomization; length of hospital stay during the index hospitalization.


Other Outcome Measures:
  1. assess tolerance of roflumilast vs. placebo in hospitalized AECOPD [ Time Frame: 180 ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Primary diagnosis of AECOPD defined as acute increase in dyspnea, sputum volume, and/or sputum purulence without other identified cause; admission to the hospital <12 hours; patient age >40, < 80 years old; cigarette smoking > 10 pack-years; informed written consent.

Exclusion Criteria:

Prior diagnosis or high suspicion for asthma based on investigator judgment; pulmonary edema, pneumonia, interstitial lung disease or significant bronchiectasis based on admission chest x-ray; intubated and mechanically ventilated at the time of evaluation; active liver disease, or transaminase elevations (> 3xULN); history of alcoholism or 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 (e.g., rifampicin, phenobarbital, carbamazepine, and phenytoin) and CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973998


Locations
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United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Forest Laboratories

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Responsible Party: Gerard Criner, Chief of Pulmonary and Critical Care Medicine, Temple University
ClinicalTrials.gov Identifier: NCT01973998     History of Changes
Other Study ID Numbers: 21474
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final data will be in a de-identified computerized dataset maintained by the investigators at Temple University. De-identified data will be shared through either password protected website maintained without cost to researchers after requests are vetted by principal investigators at Temple University.

Keywords provided by Gerard Criner, Temple University:
COPD
Emphysema
Roflumilast
readmission

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases