Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03034967 · ClinicalTrials.gov registry record · Phase 2
Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 614
- Enrollment target
NCT03034967 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 614 participants.
The verdict
NCT03034967, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 614 participants
- Enrollment target
Study Summary
Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized, double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the clinical activity and safety of danirixin compared with placebo in participants with COPD. Following baseline assessments collected over a 7 day period participants will be randomized (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram \[mg\], 10 mg, 25 mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for 24 weeks. Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while receiving study treatment. Follow up will continue up to 28 days post last dose. Approximately 700 participants will be screened with a target of 540 participants completing 24 weeks of treatment and key study assessments.
Interventions
- DRUG Rescue medication
- DRUG Standard of care
- DRUG Danirixin
- DRUG Danirixin matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2017-04-25 |
| Est. Completion | 2018-10-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03034967
The ClinicalTrials.gov registry entry for NCT03034967 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 614 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 Rescue medication is the first listed.
NCT03034967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03034967 about?
NCT03034967 is a clinical study titled "Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD)". Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized, double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the clinical activity and saf...
What is the current status of trial NCT03034967?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 614 participants. The study started on 2017-04-25. Estimated completion is 2018-10-05.
What interventions are being tested in trial NCT03034967?
The interventions under investigation include: Rescue medication (DRUG), Standard of care (DRUG), Danirixin (DRUG), Danirixin matching placebo (DRUG).
Who is sponsoring clinical trial NCT03034967?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.