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NCT01110200 · ClinicalTrials.gov registry record · Phase 4
Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study
A Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 639
- Enrollment target
- 20
- Study locations
NCT01110200 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 639 participants, below the 1,035-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT01110200, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 639 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted in the United States. The purpose of the study is to evaluate the rate of exacerbations of chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUS™ over 29 weeks. The study population will include patients hospitalized for an acute exacerbation of COPD. The target enrolment is 720 subjects at 80 study centers. The primary endpoint is the rate of exacerbation requiring hospitalization that occur more than 21 days post-discharge, emergency room visit or physician's office visit for an exacerbation of COPD requiring treatment with oral corticosteroids or oral corticosteroids and antibiotics. The secondary endpoint is the rate of COPD exacerbation requiring treatment with oral corticosteroids, antibiotics, and/or hospitalization (alone and in combination). Related efficacy endpoints include, time to first exacerbation of COPD requiring treatment with oral corticosteroids, antibiotics, and/or hospitalization (alone and in combination), pre-dose AM FEV1, the probability of premature withdrawal of subject from the study, and supplemental albuterol use, change in biomarkers of inflammation, including, surfactant protein D (SP-D), clara cell secretory protein 16 (CC-16) and high sensitivity C-reactive protein (hs-CRP). Health outcome assessments include domain scores evaluation for fatigue, dyspnea, emotional function and mastery, measured with the Chronic Respiratory Disease Questionnaire self-administered standardized format (CRQ-SAS); and symptoms (congestion, cough, phlegm, mucus, chest discomfort, shortness of breath and sleep disturbance), assessed by the EXAcerbations of Chronic pulmonary disease Tool (EXACT). Albuterol will be supplied to study subjects for use as-needed throughout the study. Sa
Conditions Studied
Interventions
- DRUG ADVAIR DISKUS 250/50 mg BID
- DRUG SEREVENT 50 mcg BID
Study Locations (20)
California
- GSK Investigational Site - Fresno
- GSK Investigational Site - Loma Linda
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Newport Beach
- GSK Investigational Site - Riverside
- GSK Investigational Site - San Diego
- GSK Investigational Site - Sepulveda
- GSK Investigational Site - Torrance
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Florence
- GSK Investigational Site - Mobile
Arizona
- GSK Investigational Site - Glendale
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tucson
Alaska
- GSK Investigational Site - Anchorage
Connecticut
- GSK Investigational Site - Hartford
District of Columbia
- GSK Investigational Site - Washington D.C.
Florida
- GSK Investigational Site - Bay Pines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 639 participants |
| Start Date | 2010-04-30 |
| Est. Completion | 2012-05-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01110200
The ClinicalTrials.gov registry entry for NCT01110200 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 639 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,035-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (38% 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 ADVAIR DISKUS 250/50 mg BID is the first listed.
NCT01110200 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01110200 about?
NCT01110200 is a clinical study titled "Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study". This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted in the United States. The purpose of the study is to evaluate the rate of exacerbations of chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute exacerbation of COPD, in patie...
What is the current status of trial NCT01110200?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 639 participants. The study started on 2010-04-30. Estimated completion is 2012-05-08.
What conditions does trial NCT01110200 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT01110200?
The interventions under investigation include: ADVAIR DISKUS 250/50 mg BID (DRUG), SEREVENT 50 mcg BID (DRUG).
Who is sponsoring clinical trial NCT01110200?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01110200 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.