ADVAIR DISKUS (Fluticasone Propionate/Salmeterol) Versus SEREVENT DISKUS (Salmeterol) On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease
This study has been terminated.
(The study was terminated due to difficulties with finding sites and subjects willing to participate.)
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00346749
First received: June 28, 2006
Last updated: October 1, 2010
Last verified: October 2010
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Purpose
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: Salmeterol Drug: Fluticasone Propionate/Salmeterol Combination Product |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD) |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Percent of sputum neutrophils
Secondary Outcome Measures:
- Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms
| Estimated Enrollment: | 180 |
| Study Start Date: | December 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Salmeterol
Drug: Fluticasone Propionate/Salmeterol Combination Product
- Salmeterol
- Fluticasone Propionate/Salmeterol Combination Product
Other Names:
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of COPD.
- Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
- Ex-Smokers with at least a 10 pack-year history.
Exclusion Criteria:
- Current of secondary diagnosis of asthma or current diagnosis of atopy.
- Other respiratory disorders other than COPD.
- Other inflammatory diseases.
- Abnormal and clinically significant chest x-ray or ECG.
- Lung resection surgery within past 1 year.
- History of cancer not in remission within past 2 years.
- Serious, uncontrolled disease.
- Pregnancy or planning to become pregnant during the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346749
Locations
| United States, Alabama | |
| GSK Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90095-1752 | |
| GSK Investigational Site | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Fort Collins, Colorado, United States, 80528 | |
| United States, Florida | |
| GSK Investigational Site | |
| Gainesville, Florida, United States, 32610 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Decatur, Georgia, United States, 30030 | |
| United States, Iowa | |
| GSK Investigational Site | |
| Iowa City, Iowa, United States, 52242 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Durham, North Carolina, United States, 27704 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00346749 History of Changes |
| Other Study ID Numbers: | ADC105931 |
| Study First Received: | June 28, 2006 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by GlaxoSmithKline:
|
Inflammation FEV1 Sputum |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013