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COMPLETED Phase 4

Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)

NCT00633217 · View on ClinicalTrials.gov ↗

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.

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

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00633217

The ClinicalTrials.gov registry entry for NCT00633217 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00633217 reports 16 study locations spanning 9 distinct geographic areas — top geographies include South Carolina, Louisiana, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00633217?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial