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 th

• Status: Terminated
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Xhance

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.