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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 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.

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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.

Conditions Studied

Asthma

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

FieldValue
Enrollment Target 339 participants
Start Date 2010-08
Est. Completion 2010-12
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT01192178

The ClinicalTrials.gov registry entry for NCT01192178 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 339 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.