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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
500 ug tablet daily for 180 days
Other Name: Daliresp
Placebo Comparator: Placebo
Placebo 1 tablet daily x 180 days
Other Name: Inactive substance
- time to all-cause mortality or re-hospitalization during the 180 days post-randomization. [ Time Frame: 180 days ]
- 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.
- assess tolerance of roflumilast vs. placebo in hospitalized AECOPD [ Time Frame: 180 ]
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
|United States, Pennsylvania|
|Temple University Hospital|
|Philadelphia, Pennsylvania, United States, 19140|