ADVAIR DISKUS® (Fluticasone Propionate/Salmeterol) Inhaler Versus SEREVENT DISKUS® (Salmeterol) Inhlaer On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease. ADVAIR DISKUS® and SEREVENT DISKUS® Inhalers Are Trademarks of the GSK Group of Companies.

Pulmonary Disease, Chronic Obstructive Clinical Trial

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 Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00346749
• Other study ID #: ADC105931
• Status: Terminated
• Phase: Phase 4
• First received: June 28, 2006
• Last updated: October 27, 2016
• Start date: December 2006
• Est. completion date: July 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Salmeterol

• Fluticasone Propionate/Salmeterol Combination Product

Locations

Country	Name	City	State
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of sputum neutrophils
Secondary	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

External Links

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