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NCT00355342 · ClinicalTrials.gov registry record · Phase 4

Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.

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

Completed
Registry status
Phase 4
Development phase
186
Enrollment target
20
Study locations

NCT00355342: Completed Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.

NCT00355342 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 186 participants, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00355342, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.

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

Study Summary

This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).

Primary Outcome

BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was

Conditions Studied

Pulmonary Disease, Chronic Obstructive

Interventions

  • DRUG Salmeterol 50 mcg BID
  • DRUG Fluticasone Propionate/Salmeterol 250/50 mcg BID
  • DEVICE DISKUS inhaler

Study Locations (20)

California

  • GSK Investigational Site - Berkeley
  • GSK Investigational Site - Fullerton
  • GSK Investigational Site - Rancho Mirage
  • GSK Investigational Site - San Diego
  • GSK Investigational Site - Walnut Creek

Florida

  • GSK Investigational Site - Fort Lauderdale
  • GSK Investigational Site - Jacksonville
  • GSK Investigational Site - Sarasota
  • GSK Investigational Site - Tamarac

Colorado

  • GSK Investigational Site - Fort Collins
  • GSK Investigational Site - Wheat Ridge

Illinois

  • GSK Investigational Site - Chicago
  • GSK Investigational Site - North Chicago

Connecticut

  • GSK Investigational Site - Hartford

Georgia

  • GSK Investigational Site - Atlanta

Kansas

  • GSK Investigational Site - Wichita

Massachusetts

  • GSK Investigational Site - Boston

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2004-04-28
Est. Completion 2007-09-06
Phase Phase 4
GlaxoSmithKline

1,345 total trials

What the finished NCT00355342 record still lists

NCT00355342 is an interventional study that assigns participants to a tested intervention. The registered 186 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 (82% lower).

The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which Salmeterol 50 mcg BID is the first listed.

NCT00355342 names 20 study sites across 11 states, led by California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT00355342 about?

NCT00355342 is a clinical study titled "Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.". This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic ...

What is the current status of trial NCT00355342?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 186 participants. The study started on 2004-04-28. Estimated completion is 2007-09-06.

What conditions does trial NCT00355342 study?

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

What interventions are being tested in trial NCT00355342?

The interventions under investigation include: Salmeterol 50 mcg BID (DRUG), Fluticasone Propionate/Salmeterol 250/50 mcg BID (DRUG), DISKUS inhaler (DEVICE).

Who is sponsoring clinical trial NCT00355342?

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

Where is trial NCT00355342 being conducted?

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

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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 NCT00355342's enrollment target sits among peer trials

186 47th of 74 higher than 28 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 NCT00355342, the US trial registry maintained by the National Library of Medicine. NCT00355342 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.