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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.

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
GlaxoSmithKline

1,345 total trials

What the finished NCT00633217 record still lists

NCT00633217 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (76% lower).

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 lists 16 locations in 9 states (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.

Learn More About Clinical Trials

Similar trials for Pulmonary Disease, Chronic Obstructive

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 NCT00633217's enrollment target sits among peer trials

247 43rd of 74 higher than 32 of 74 other Pulmonary Disease, Chronic Obstructive trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00633217, the US trial registry maintained by the National Library of Medicine. NCT00633217 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.