Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01894386 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses
A Phase 1 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01894386: Completed Phase 1 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT01894386 is a Phase 1 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 48 participants, below the 1,043-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01894386, a Phase 1 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one inhaler (at two different strengths of UMEC (125 and 62.5microgram \[mcg\]) and FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA). Subjects will receive each of the four treatments once, separated by a wash-out period of 7-21 days between doses in a four way crossover design. There will be 4 treatment periods in total. During each treatment period, subjects will attend the clinical unit on Day -1 for standard safety assessments in addition to familiarization with the inhaler. Each subject will remain resident in the unit until at least 24 hours after the dose given on Day 1. Following completion of all four treatment periods, a follow up visit will take place 7 to 21 days following the final dose of study medication.
Primary Outcome
Area under the concentration time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)) (or Area under the concentration time curve from time zero (pre-dose) to last common time of quantifiable concentration within a subject across all treatments \[AUC(0-t')\] if AUC(0-infinity) cannot be determined) and maximum observed concentration (Cmax) for each individual component (UMEC will be dose-normalised) across treatment groups will be estimated using the following treatme
Conditions Studied
Interventions
- DRUG FF 400 mcg
- DRUG UMEC 500 mcg
- DRUG UMEC 250 mcg
- DRUG VI 100 mcg
Study Locations (1)
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-07-15 |
| Est. Completion | 2013-09-26 |
| Phase | Phase 1 |
What the finished NCT01894386 record still lists
NCT01894386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,043-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 4 interventions - of which FF 400 mcg is the first listed.
NCT01894386 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01894386 about?
NCT01894386 is a clinical study titled "Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses". This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one inhaler (at two different strengths of UMEC (125 and 62.5microgram \[mcg\]) and FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA). Subjects will receive each of the four treatments once, separated by a wash-out period of ...
What is the current status of trial NCT01894386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-07-15. Estimated completion is 2013-09-26.
What conditions does trial NCT01894386 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT01894386?
The interventions under investigation include: FF 400 mcg (DRUG), UMEC 500 mcg (DRUG), UMEC 250 mcg (DRUG), VI 100 mcg (DRUG).
Who is sponsoring clinical trial NCT01894386?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01894386 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Disease, Chronic Obstructive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01894386's enrollment target sits among peer trials
48 58th of 74 higher than 16 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
RECRUITING · Phase 1
-
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib
COMPLETED · Phase 1
-
Transforming Psychotherapy for Chronically Ill Patients
COMPLETED · Phase 1
-
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects
COMPLETED · Phase 1
-
Real-Time Support for Exercise Persistence in COPD
COMPLETED · Phase 1
-
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01765777 · 48 participants · NA
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- NCT03073343 · 48 participants · NA
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
- NCT03431064 · 48 participants
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- NCT03514602 · 48 participants · NA
Maternal Smoking Cessation and Pediatric Obesity Prevention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI