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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT03034967 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 614 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (362% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range \[0-17\]), RS-cough and sputum (RS-CSP comprised of 3 items, score range \[0-11\]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range \[0-12\]). The total score ranged between 0-40 and higher values indicates severe respira
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 |
What the finished NCT03034967 record still lists
NCT03034967 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (362% higher).
The record links to 0 conditions, and to 4 interventions - of which Rescue medication is the first listed.
NCT03034967 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03034967's enrollment target sits among peer trials
614 53rd of 2000 higher than 1,948 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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