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NCT03170232 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT03170232 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 54 participants.
The verdict
NCT03170232, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a pilot study to investigate the effect of danirixin hydrobromide 35 milligram (mg) tablets on lung function and health related quality of life (HRQoL) in subjects with mild to moderate airflow obstruction and a demonstrated history of decline in forced expiratory volume in one second (FEV1). Specifically, this study aims to assess whether or not danirixin has the potential to impact disease progression in subjects with a COPD progression score indicating they are likely to decline based on 5 year data from a COPDGene study and support the conduct of a larger Phase III study for disease progression. Subjects will receive either placebo or danirixin 35 mg tablets (as hydrobromide hemihydrate salt) twice daily for 52 weeks (12months). Study subjects will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while receiving study treatment. This study will be an ancillary study within the COPDGene study investigating the enrichment strategy for assessing disease progression. Potential subjects most likely to decline from the well established COPDGene cohort, will be based on data collected over the initial 5 year period. With the use of an enriched population, it is anticipated that one year of treatment will be sufficient to detect a trend in altering disease progression. Approximately 130 subjects will be screened to enroll 100 subjects in this study. The data from this study will provide useful information in determining whether to progress to a Phase III study to explore an indication for slowing disease progression.
Interventions
- DRUG Placebo
- DRUG Rescue medication
- DRUG Danirixin 35 mg tablets
- DEVICE Metered dose inhaler (MDI) sensor device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2018-11-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03170232
The ClinicalTrials.gov registry entry for NCT03170232 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03170232 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03170232 about?
NCT03170232 is a clinical study titled "A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD)". This is a pilot study to investigate the effect of danirixin hydrobromide 35 milligram (mg) tablets on lung function and health related quality of life (HRQoL) in subjects with mild to moderate airflow obstruction and a demonstrated history of decline in forced expiratory volume in one second (FEV1)...
What is the current status of trial NCT03170232?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2017-10-16. Estimated completion is 2018-11-15.
What interventions are being tested in trial NCT03170232?
The interventions under investigation include: Placebo (DRUG), Rescue medication (DRUG), Danirixin 35 mg tablets (DRUG), Metered dose inhaler (MDI) sensor device (DEVICE).
Who is sponsoring clinical trial NCT03170232?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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