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NCT01192178 · ClinicalTrials.gov registry record · Phase 4
Fall Epidemic Viral Pediatric Study
A Phase 4 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 339
- Enrollment target
- 20
- Study locations
NCT01192178: Completed Phase 4 study of Asthma, sponsored by GlaxoSmithKline.
NCT01192178 is a Phase 4 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 339 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192178, a Phase 4 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 339 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment starting in April 2010. Eligible subjects will be invited to return for randomization into the study in August 2010. This exploratory study is being conducted to assess whether treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of exacerbation and the asthma impairment associated with viral respiratory tract infections during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.
Primary Outcome
An asthma exacerbation was defined as deterioration of asthma that required the use of outpatient oral/parenteral corticosteroids (tablets, suspensions, or injection) or an urgent care, hospitalization, or emergency room (ER) visit due to asthma that required oral/parenteral corticosteroids. Two exacerbations (out of a total of 51) were excluded: (1) one exacerbation occurred within 7 days of the resolution of an earlier one, and, per protocol, was combined with the previous exacerbation; and (2
Conditions Studied
Interventions
- DRUG FLOVENT™ DISKUS™ 100 mcg BID
- DRUG ADVAIR™ DISKUS™ 100/50 mcg BID
Study Locations (20)
California
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Fresno
- GSK Investigational Site - Granada Hills
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Orange
- GSK Investigational Site - Riverside
- GSK Investigational Site - Sacramento
- GSK Investigational Site - San Diego
- GSK Investigational Site - Walnut Creek
Georgia
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Gainesville
- GSK Investigational Site - Lawrenceville
Arizona
- GSK Investigational Site - Tucson
Colorado
- GSK Investigational Site - Colorado Springs
Florida
- GSK Investigational Site - St. Petersburg
Kentucky
- GSK Investigational Site - Owensboro
Michigan
- GSK Investigational Site - Ypsilanti
New Jersey
- GSK Investigational Site - Brick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2010-08 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
What the finished NCT01192178 record still lists
NCT01192178 is an interventional study that assigns participants to a tested intervention. The registered 339 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 (78% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which FLOVENT™ DISKUS™ 100 mcg BID is the first listed.
NCT01192178 names 20 study sites across 9 states, led by California, Georgia, Arizona.
Frequently Asked Questions
What is clinical trial NCT01192178 about?
NCT01192178 is a clinical study titled "Fall Epidemic Viral Pediatric Study". Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects w...
What is the current status of trial NCT01192178?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 339 participants. The study started on 2010-08. Estimated completion is 2010-12.
What conditions does trial NCT01192178 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01192178?
The interventions under investigation include: FLOVENT™ DISKUS™ 100 mcg BID (DRUG), ADVAIR™ DISKUS™ 100/50 mcg BID (DRUG).
Who is sponsoring clinical trial NCT01192178?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01192178 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01192178's enrollment target sits among peer trials
339 110th of 374 higher than 263 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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