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NCT00452699 · ClinicalTrials.gov registry record · Phase 4

A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma

A Phase 4 study of Asthma, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
621
Enrollment target
20
Study locations

NCT00452699 is a Phase 4 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 621 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00452699, a Phase 4 study of Asthma, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
621 participants
Enrollment target
20
Study locations

Study Summary

This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Conditions Studied

Asthma

Interventions

  • DRUG Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
  • DRUG Fluticasone propionate 250 mcg BID

Study Locations (20)

California

  • GSK Investigational Site - Fountain Valley
  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Rancho Mirage
  • GSK Investigational Site - Riverside
  • GSK Investigational Site - San Jose

Florida

  • GSK Investigational Site - Coral Gables
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Pensacola
  • GSK Investigational Site - Tallahassee
  • GSK Investigational Site - Tamarac

Colorado

  • GSK Investigational Site - Denver
  • GSK Investigational Site - Denver
  • GSK Investigational Site - Fort Collins
  • GSK Investigational Site - Fort Collins

Georgia

  • GSK Investigational Site - Columbus
  • GSK Investigational Site - Conyers
  • GSK Investigational Site - Lilburn

Arizona

  • GSK Investigational Site - Scottsdale

Arkansas

  • GSK Investigational Site - Little Rock

Connecticut

  • GSK Investigational Site - Stamford

Trial Details

FieldValue
Enrollment Target 621 participants
Start Date 2007-05
Est. Completion 2009-05
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00452699

The ClinicalTrials.gov registry entry for NCT00452699 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 621 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 (60% 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 Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID is the first listed.

NCT00452699 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT00452699 about?

NCT00452699 is a clinical study titled "A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma". This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide...

What is the current status of trial NCT00452699?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 621 participants. The study started on 2007-05. Estimated completion is 2009-05.

What conditions does trial NCT00452699 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT00452699?

The interventions under investigation include: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID (DRUG), Fluticasone propionate 250 mcg BID (DRUG).

Who is sponsoring clinical trial NCT00452699?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00452699 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.