Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease
Public ClinicalTrials.gov record NCT02573870. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
201546, A Repeat-dose Study of Batefenterol/FF (GSK961081/GW685698) Compared With Placebo in the Treatment of COPD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02573870
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2015
- Primary completion
- Jul 4, 2016
- Completion
- Jul 4, 2016
- Last update posted
- Jul 20, 2020
2015 – 2016
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85006 | — |
| GSK Investigational Site | Hollywood | Florida | 33021 | — |
| GSK Investigational Site | Baltimore | Maryland | 21225 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Gastonia | North Carolina | 28054 | — |
| GSK Investigational Site | Grove City | Ohio | 43123 | — |
| GSK Investigational Site | Easley | South Carolina | 29640 | — |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | — |
| GSK Investigational Site | Seneca | South Carolina | 29678 | — |
| GSK Investigational Site | McKinney | Texas | 75069 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02573870, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2020 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02573870 live on ClinicalTrials.gov.