Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Fluticasone Propionate/Salmeterol Combination Product (Drug); Salmeterol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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 FDA for use in
patients with COPD.
Clinical Details
Official title: See Detailed Description
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Rate of moderate/severe exacerbations over a 52 week treatment period
Secondary outcome: The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year
Detailed description:
A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the
Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol
DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Diagnosis of COPD.
- Current or previous cigarette smokers with a smoking history of at least 10
pack-years.
- History of at 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.
Exclusion criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: December 2004
Last updated: April 15, 2015
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