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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: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT03345407 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 943 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (609% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
FEV1 is maximal amount of air exhaled forcefully from lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10-30 minutes after participant was administered 4 inhalations of albuterol (salbutamol) via MDI using spacer/valved-holding chamber or via one nebulized treatment. Post-bronchodilator Baseline FEV1 is latest FEV1 measured prior to first dose of study treatment and post-bronchodilator. Change from Baseline in clinic visit trough FEV1 at Day 84 measured post-bronchodilator
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 |
Why NCT03345407 stopped before completion
NCT03345407 is an interventional study that assigns participants to a tested intervention. The registered 943 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 (609% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo ELLIPTA is the first listed.
NCT03345407 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03345407's enrollment target sits among peer trials
943 29th of 2000 higher than 1,972 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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