Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03345407 · ClinicalTrials.gov registry record · Phase 2
Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 943
- Enrollment target
NCT03345407 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 943 participants.
The verdict
NCT03345407, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 943 participants
- Enrollment target
Study Summary
Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a range of doses \[up to 750 micrograms (µg)\] compared with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a 12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in this double-blind study. Subjects will be randomized to receive different doses of nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
Interventions
- DRUG Placebo ELLIPTA
- DRUG Nemiralisib ELLIPTA 50 µg
- DRUG Nemiralisib ELLIPTA 100 µg
- DRUG Nemiralisib ELLIPTA 250 µg
- DRUG Nemiralisib ELLIPTA 500 µg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 943 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2019-01-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03345407
The ClinicalTrials.gov registry entry for NCT03345407 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 943 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 5 interventions - of which Placebo ELLIPTA is the first listed.
NCT03345407 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03345407 about?
NCT03345407 is a clinical study titled "Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)". Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a range of doses \[up to 750 micrograms (µg)\] compared with placebo. The st...
What is the current status of trial NCT03345407?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 943 participants. The study started on 2017-11-28. Estimated completion is 2019-01-10.
What interventions are being tested in trial NCT03345407?
The interventions under investigation include: Placebo ELLIPTA (DRUG), Nemiralisib ELLIPTA 50 µg (DRUG), Nemiralisib ELLIPTA 100 µg (DRUG), Nemiralisib ELLIPTA 250 µg (DRUG), Nemiralisib ELLIPTA 500 µg (DRUG).
Who is sponsoring clinical trial NCT03345407?
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.