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NCT01973998 · ClinicalTrials.gov registry record · Phase 3
Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization
A Phase 3 study, sponsored by Temple University.
- Completed
- Registry status
- Phase 3
- Development phase
- 68
- Enrollment target
NCT01973998 is a Phase 3 study that has completed, run by Temple University. The registered enrollment target is 68 participants.
The verdict
NCT01973998, a Phase 3 study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 68 participants
- Enrollment target
Study 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
Interventions
- DRUG Placebo
- DRUG Roflumilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01973998
The ClinicalTrials.gov registry entry for NCT01973998 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01973998 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01973998 about?
NCT01973998 is a clinical study titled "Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization". 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, pr...
What is the current status of trial NCT01973998?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2013-11. Estimated completion is 2017-11-30.
What interventions are being tested in trial NCT01973998?
The interventions under investigation include: Placebo (DRUG), Roflumilast (DRUG).
Who is sponsoring clinical trial NCT01973998?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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