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Sponsors and Collaborators: |
Leiden University Medical Center Academisch Ziekenhuis Groningen The Netherlands Asthma Foundation NWO GlaxoSmithKline |
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Information provided by: | Leiden University Medical Center |
ClinicalTrials.gov Identifier: | NCT00158847 |
The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease |
Drug: fluticasone 500 mcg Drug: fluticasone 500 mcg + salmeterol 50 mcg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist. |
Estimated Enrollment: | 200 |
Study Start Date: | April 2000 |
Estimated Study Completion Date: | May 2005 |
Aim The primary aim of this study was to investigate whether short-term treatment with inhaled corticosteroids in COPD results in greater improvements in airway pathology, thereby leading to larger clinical benefits, than continuous long-term treatment. To that end, the outcome variables included features of airways inflammation and remodelling as well as clinical symptoms, exacerbations, quality of life, decline in FEV1, bronchial responsiveness, and pharmaco-economics. The secondary aim of the study was to examine the histopathological and clinical benefits of the combined treatment with an inhaled steroid and a long-acting ß2-agonist in COPD. Methods Patients. Patients with COPD (45-75 yr, >10 pckyr) not using inhaled steroids for the past 3 months were recruited.
Design. In a prospective, longitudinal, double blind, 4-arm study, the patients were followed during 2.5 years (Figure 1). They were treated with high dose inhaled corticosteroids (500 g fluticasone bid), combined inhaled steroids+long-acting ß2-agonist (500 µg fluticasone+50 µg salmeterol) or placebo for 6 months. Half of the patients in the steroid group continued their treatment with steroids for another 2 years, whereas the other half received placebo. The combination therapy and placebo groups remained unaltered treatment up to 2.5 years.
Measurements. Symptoms, exacerbations, QOL questionnaires and spirometry were monitored every 3 months. Peripheral blood eosinophils, IgE, exhaled NO, bodyplethysmography, CO-diffusion capacity, PC20 methacholine, sputum induction and bronchoscopy were performed at 0, 6, and 30 months. In BAL and induced sputum we are measuring cell differentials and their state of activation. Immunohistochemistry is being performed in bronchial biopsy specimens, staining for markers on infiltrative and resident cells, and morphometric analysis will allow airway remodelling to be quantified, by using a computerized image analysis system. The effects of treatment will be analyzed by relating the observed changes in clinical and pathophysiological outcome, to those in cellular and histological outcome by using linear mixed statistical models.
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Netherlands | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC | |
University Medical Center Groningen | |
Groningen, Netherlands, 9700 RB |
Principal Investigator: | Peter J. Sterk, MD, PhD | Leiden University Medical Center |
Study ID Numbers: | SCO30001, SER9804 / Glucold |
Study First Received: | September 8, 2005 |
Last Updated: | January 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00158847 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
COPD inflammation sputum lung function biopsy |
Anti-Inflammatory Agents Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Lung Diseases Anti-Asthmatic Agents |
Fluticasone Anti-Allergic Agents Peripheral Nervous System Agents Bronchodilator Agents Inflammation Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive Respiratory Tract Diseases |
Autonomic Agents Lung Diseases Therapeutic Uses Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |