ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Trademarks of the GSK Group of Companies.

Completed · Phase 4

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.

Key facts

Study ID

NCT00144911

Run by

GlaxoSmithKline

People needed

740

Starts

2004-10-01

Expected to finish

2006-12-01

Last updated by the study team

2016-10-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of COPD (chronic obstructive pulmonary disease).
• Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
• History of a least 1 COPD exacerbation in the 12 months prior to screening.
• Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

You may not qualify if…

• Current diagnosis of asthma.
• Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
• Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
• Lung resection surgery within 1 year of screening.
• Abnormal and clinically significant ECG findings at screening.
• Other inclusion and exclusion criteria will be evaluated at the first study visit.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — Glendale, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Corona, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Palmdale, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Rancho Mirage, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Sepulveda, California, United States
• GSK Investigational Site — Stockton, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Englewood, Colorado, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Largo, Florida, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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