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NCT01573624 · ClinicalTrials.gov registry record · Phase 2
Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma
A Phase 2 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 421
- Enrollment target
- 20
- Study locations
NCT01573624: Completed Phase 2 study of Asthma, sponsored by GlaxoSmithKline.
NCT01573624 is a Phase 2 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 421 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01573624, a Phase 2 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 421 participants
- Enrollment target
- 20
- Study locations
Study Summary
Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control. Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.
Primary Outcome
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 ante meridiem (AM) and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from bas
Conditions Studied
Interventions
- DRUG FF/GSK573719
Study Locations (20)
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Mendoza
- GSK Investigational Site - San Miguel de Tucumán
- GSK Investigational Site - San Miguel de Tucumán
- GSK Investigational Site - Santiago
- GSK Investigational Site - Barnaul
- GSK Investigational Site - Kazan'
- GSK Investigational Site - Klin
Región Metro de Santiago
- GSK Investigational Site - Puente Alto - Santiago
- GSK Investigational Site - Santiago
- GSK Investigational Site - Santiago
- GSK Investigational Site - Santiago
- GSK Investigational Site - Talca
South Carolina
- GSK Investigational Site - Orangeburg
- GSK Investigational Site - Spartanburg
Missouri
- GSK Investigational Site - St Louis
Oregon
- GSK Investigational Site - Medford
Región de Valparaíso
- GSK Investigational Site - Valparaíso
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 421 participants |
| Start Date | 2012-04-03 |
| Est. Completion | 2013-02-04 |
| Phase | Phase 2 |
What the finished NCT01573624 record still lists
NCT01573624 is an interventional study that assigns participants to a tested intervention. The registered 421 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which FF/GSK573719 is the first listed.
NCT01573624 names 20 study sites across 6 states, led by Other, Región Metro de Santiago, South Carolina.
Frequently Asked Questions
What is clinical trial NCT01573624 about?
NCT01573624 is a clinical study titled "Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma". Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control. Detailed Description: L...
What is the current status of trial NCT01573624?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 421 participants. The study started on 2012-04-03. Estimated completion is 2013-02-04.
What conditions does trial NCT01573624 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01573624?
The interventions under investigation include: FF/GSK573719 (DRUG).
Who is sponsoring clinical trial NCT01573624?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01573624 being conducted?
This trial has 20 study locations across Missouri, Oregon, South Carolina, Región de Valparaíso, Región Metro de Santiago. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
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 NCT01573624's enrollment target sits among peer trials
421 89th of 374 higher than 286 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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