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NCT02799784 · ClinicalTrials.gov registry record · Phase 4
An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients
A Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 236
- Enrollment target
- 20
- Study locations
NCT02799784: Completed Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT02799784 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 236 participants, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02799784, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 236 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD. This is a multicentre, randomized, open label, 2 period crossover complete block design study. Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram \[mcg\] once-daily \[QD\]) administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be followed by a 3-week washout period and one-week follow-up period. The total duration of subject participation in the study will be approximately 22 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a registered trademark of Boehringer Ingelheim.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as 23 and 24 hour post-dose FEV1 measurements. All par. in the Intent To Treat (ITT) Population who were not identified as full protocol deviators were included in Per-Protocol (PP) Population. ITT Population, comprised of all randomized subjects, who received at least one dose of study medication.
Conditions Studied
Interventions
- DRUG UMEC/VI
- DRUG TIO/OLO
- DRUG Albuterol/salbutamol
Study Locations (20)
South Carolina
- GSK Investigational Site - Charleston
- GSK Investigational Site - Greenville
- GSK Investigational Site - Spartanburg
Hesse
- GSK Investigational Site - Frankfurt am Main
- GSK Investigational Site - Frankfurt am Main
- GSK Investigational Site - Neu-Isenburg
Other
- GSK Investigational Site - Magdeburg
- GSK Investigational Site - Alicante
- GSK Investigational Site - Girona
Florida
- GSK Investigational Site - Clearwater
- GSK Investigational Site - Orlando
Saxony
- GSK Investigational Site - Dresden
- GSK Investigational Site - Leipzig
Missouri
- GSK Investigational Site - St Louis
Oregon
- GSK Investigational Site - Medford
Virginia
- GSK Investigational Site - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2016-07-14 |
| Est. Completion | 2017-04-27 |
| Phase | Phase 4 |
What the finished NCT02799784 record still lists
NCT02799784 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which UMEC/VI is the first listed.
NCT02799784 names 20 study sites across 12 states, led by South Carolina, Hesse, Other.
Frequently Asked Questions
What is clinical trial NCT02799784 about?
NCT02799784 is a clinical study titled "An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients". The primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD. This is a multicentre, randomized, open label, 2 period crossover complete block design study. Eligible subjects, who complete a ...
What is the current status of trial NCT02799784?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 236 participants. The study started on 2016-07-14. Estimated completion is 2017-04-27.
What conditions does trial NCT02799784 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02799784?
The interventions under investigation include: UMEC/VI (DRUG), TIO/OLO (DRUG), Albuterol/salbutamol (DRUG).
Who is sponsoring clinical trial NCT02799784?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02799784 being conducted?
This trial has 20 study locations across Florida, Missouri, Oregon, South Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02799784's enrollment target sits among peer trials
236 45th of 74 higher than 30 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive 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.
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