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NCT02573870 · ClinicalTrials.gov registry record · Phase 2
Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT02573870 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 63 participants.
The verdict
NCT02573870, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
Batefenterol inhalation powder is currently under development as a fixed-dose combination with fluticasone furoate (FF) for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The present study will administer batefenterol/FF (300/100 micrograms \[mcg\]) for the first time to subjects with COPD, to investigate the safety and tolerability of the combination compared with placebo, and to evaluate the pharmacokinetics and pharmacodynamics profiles of the individual components when administered in combination. This is a Phase IIa, multicenter, randomized, placebo-controlled, double-blind, parallel group study. Subjects will be randomized (2:1) to one of the following double-blind treatment groups: Batefenterol/FF 300/100 mcg inhalation powder once daily, or matching placebo inhalation powder once daily. Subjects will self-administer the study treatments once daily (QD) in the morning for 42 days via a multi-dose dry powder inhaler (DPI) which contains two blister strips. Additionally, an inhaled short acting beta2-receptor agonist, albuterol will be provided from screening to the end of the treatment period for all subjects to use as needed to relieve COPD symptoms. At the end of the treatment period, subjects can resume conventional therapy. The study will randomize approximately 60 subjects. The total duration of subject participation (from screening to follow-up) will be approximately 8 weeks.
Interventions
- DRUG Placebo
- DRUG Albuterol
- DRUG Batefenterol + Fluticasone Furoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2015-12-01 |
| Est. Completion | 2016-07-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02573870
The ClinicalTrials.gov registry entry for NCT02573870 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 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 3 interventions - of which Placebo is the first listed.
NCT02573870 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02573870 about?
NCT02573870 is a clinical study titled "Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease". Batefenterol inhalation powder is currently under development as a fixed-dose combination with fluticasone furoate (FF) for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The present study will administer batefenterol/FF (300/100 micrograms \[mcg\]) for the first time to subjects wi...
What is the current status of trial NCT02573870?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2015-12-01. Estimated completion is 2016-07-05.
What interventions are being tested in trial NCT02573870?
The interventions under investigation include: Placebo (DRUG), Albuterol (DRUG), Batefenterol + Fluticasone Furoate (DRUG).
Who is sponsoring clinical trial NCT02573870?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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