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NCT00633217 · ClinicalTrials.gov registry record · Phase 4

Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)

A Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
247
Enrollment target
16
Study locations

NCT00633217 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 247 participants, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (76% lower). The trial reports 16 study locations across 9 states.

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The verdict

NCT00633217, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
247 participants
Enrollment target
16
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests and will record their peak expiratory flow measurements daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in asthma and COPD.

Conditions Studied

Pulmonary Disease, Chronic Obstructive

Interventions

  • DRUG Fluticasone Propionate/Salmeterol DISKUS 250/50mcg
  • DRUG Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg

Study Locations (16)

South Carolina

  • GSK Investigational Site - Charleston
  • GSK Investigational Site - Gaffney
  • GSK Investigational Site - Greenville
  • GSK Investigational Site - Spartanburg
  • GSK Investigational Site - Union

Louisiana

  • GSK Investigational Site - Lafayette
  • GSK Investigational Site - New Orleans
  • GSK Investigational Site - Sunset

Alabama

  • GSK Investigational Site - Jasper
  • GSK Investigational Site - Mobile

Missouri

  • GSK Investigational Site - Saint Charles

North Carolina

  • GSK Investigational Site - Elizabeth City

Pennsylvania

  • GSK Investigational Site - Erie

Texas

  • GSK Investigational Site - Corsicana

Virginia

  • GSK Investigational Site - Richmond

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2008-03
Est. Completion 2009-02
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00633217

The ClinicalTrials.gov registry entry for NCT00633217 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (76% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions - of which Fluticasone Propionate/Salmeterol DISKUS 250/50mcg is the first listed.

NCT00633217 reports 16 study locations spanning 9 distinct geographic areas - top geographies include South Carolina, Louisiana, Alabama.

Frequently Asked Questions

What is clinical trial NCT00633217 about?

NCT00633217 is a clinical study titled "Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)". The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. T...

What is the current status of trial NCT00633217?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 247 participants. The study started on 2008-03. Estimated completion is 2009-02.

What conditions does trial NCT00633217 study?

This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.

What interventions are being tested in trial NCT00633217?

The interventions under investigation include: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (DRUG), Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg (DRUG).

Who is sponsoring clinical trial NCT00633217?

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

Where is trial NCT00633217 being conducted?

This trial has 16 study locations across Alabama, Louisiana, Missouri, North Carolina, Pennsylvania. 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.