ADVAIR DISKUS (Fluticasone Propionate/Salmeterol) Versus SEREVENT DISKUS (Salmeterol) On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Salmeterol (Drug); Fluticasone Propionate/Salmeterol Combination Product (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline

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.

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)

Study design: Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percent of sputum neutrophils

Secondary outcome: 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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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.

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Starting date: June 2006
Last updated: November 12, 2007