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NCT02570165 · ClinicalTrials.gov registry record · Phase 2
Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 325
- Enrollment target
NCT02570165: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02570165 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 325 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02570165, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 325 participants
- Enrollment target
Study Summary
Batefenterol is a novel bifunctional molecule that combines muscarinic antagonism and beta2-agonism in a single molecule. This is a multicenter, randomized, placebo-controlled, double-blind, parallel group study primarily designed to assess the dose response, efficacy and safety of five dose regimens of batefenterol administered via the dry powder inhaler (DPI) once-daily in the morning for 42 days in subjects with COPD. The information obtained from this study will be used to select the minimal, optimally effective and safe dose of batefenterol and also to evaluate the pharmacokinetic profile and established pharmacodynamic (PD) responses of batefenterol. These data will support for future studies with batefenterol in COPD subjects. The study will consist of a pre-screening visit, screening visit; a run-in period (2 weeks), treatment period of 42 days and a follow-up visit 7 days post-treatment. The total duration of the study for each subject will be approximately 9 weeks. Approximately 460 subjects will be screened in order to randomize approximately 320 subjects, assuming that 280 subjects will complete the study. During treatment period, subjects will be randomized to one of the following treatments delivered via DPI once daily in the morning: Batefenterol 37.5 mcg, 75 mcg, 150 mcg, 300 mcg and 600 mcg, umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg and placebo. All subjects will receive supplemental albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study.
Primary Outcome
FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath. Weighted-mean change from Baseline was the weighted-mean FEV1 on Day 42 minus Baseline where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The 0-6 hour (Hr.) serial FEV1 was collected at Day 1 (Visit 2) and Day 42 (Visit 6). The weighted-mean was derived by calculating the area under the curve (AUC) of FEV1 over the 6 hour period, and then dividi
Interventions
- DRUG Placebo
- DRUG Batefenterol
- DRUG Umeclidinium/ Vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2015-11-06 |
| Est. Completion | 2016-07-06 |
| Phase | Phase 2 |
What the finished NCT02570165 record still lists
NCT02570165 is an interventional study that assigns participants to a tested intervention. The registered 325 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 (144% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02570165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02570165 about?
NCT02570165 is a clinical study titled "Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)". Batefenterol is a novel bifunctional molecule that combines muscarinic antagonism and beta2-agonism in a single molecule. This is a multicenter, randomized, placebo-controlled, double-blind, parallel group study primarily designed to assess the dose response, efficacy and safety of five dose regimen...
What is the current status of trial NCT02570165?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 325 participants. The study started on 2015-11-06. Estimated completion is 2016-07-06.
What interventions are being tested in trial NCT02570165?
The interventions under investigation include: Placebo (DRUG), Batefenterol (DRUG), Umeclidinium/ Vilanterol (DRUG).
Who is sponsoring clinical trial NCT02570165?
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 NCT02570165's enrollment target sits among peer trials
325 148th of 2000 higher than 1,852 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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