Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
200 participants
INTERVENTIONAL
2000-04-30
2005-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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fluticasone 500 mcg
fluticasone 500 mcg + salmeterol 50 mcg
Eligibility Criteria
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Inclusion Criteria
* Written informed consent.
* Able to complete a diary card.
* At least one of the following symptoms: chronic cough, chronic sputum production, frequent exacerbations, or dyspnoea at exertion.
* Postbronchodilator FEV1 below 90% confidence interval of predicted and postbronchodilator FEV1/FVC below 90% confidence interval of predicted.
Exclusion Criteria
* No history of asthma, lung diseases other than COPD, other diseases likely to interfere with the study.
45 Years
75 Years
ALL
No
Sponsors
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Academisch Ziekenhuis Groningen
OTHER
The Netherlands Asthma Foundation
OTHER
Netherlands Organisation for Scientific Research
OTHER_GOV
GlaxoSmithKline
INDUSTRY
Leiden University Medical Center
OTHER
Principal Investigators
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Peter J. Sterk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Countries
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References
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Lapperre TS, Snoeck-Stroband JB, Gosman MM, Stolk J, Sont JK, Jansen DF, Kerstjens HA, Postma DS, Sterk PJ; Groningen and Leiden Universities Corticosteroids in Obstructive Lung Disease Study Group. Dissociation of lung function and airway inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Sep 1;170(5):499-504. doi: 10.1164/rccm.200401-112OC. Epub 2004 Jun 1.
Fang J, Wolters JC, Rafie K, Wang C, Bartel S, van den Berge M, Hylkema MN. Extracellular vesicles from bronchoalveolar lavage fluid provide insights into the inhaled corticosteroids treatment response in COPD. Respir Res. 2025 Jul 30;26(1):254. doi: 10.1186/s12931-025-03330-6.
Ditz B, Boekhoudt J, Couto N, Brandsma CA, Hiemstra PS, Tew GW, Neighbors M, Grimbaldeston MA, Timens W, Kerstjens HAM, Rossen JWA, Guryev V, van den Berge M, Faiz A. The Microbiome in Bronchial Biopsies from Smokers and Ex-Smokers with Stable COPD - A Metatranscriptomic Approach. COPD. 2022;19(1):81-87. doi: 10.1080/15412555.2022.2033193. Epub 2022 Feb 4.
Faiz A, Imkamp K, van der Wiel E, Boudewijn IM, Koppelman GH, Brandsma CA, Kerstjens HAM, Timens W, Vroegop S, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Steiling K, Spira A, Lenburg ME, Heijink IH, Postma DS, van den Berge M. Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD. Sci Rep. 2020 Oct 15;10(1):17415. doi: 10.1038/s41598-020-72551-0.
Kunz LI, van't Wout EF, van Schadewijk A, Postma DS, Kerstjens HA, Sterk PJ, Hiemstra PS. Regulation of YKL-40 expression by corticosteroids: effect on pro-inflammatory macrophages in vitro and its modulation in COPD in vivo. Respir Res. 2015 Dec 22;16:154. doi: 10.1186/s12931-015-0314-3.
Snoeck-Stroband JB, Lapperre TS, Sterk PJ, Hiemstra PS, Thiadens HA, Boezen HM, Ten Hacken NH, Kerstjens HA, Postma DS, Timens W, Sont JK; GLUCOLD Study Group. Prediction of Long-Term Benefits of Inhaled Steroids by Phenotypic Markers in Moderate-to-Severe COPD: A Randomized Controlled Trial. PLoS One. 2015 Dec 10;10(12):e0143793. doi: 10.1371/journal.pone.0143793. eCollection 2015.
Kunz LIZ, Postma DS, Klooster K, Lapperre TS, Vonk JM, Sont JK, Kerstjens HAM, Snoeck-Stroband JB, Hiemstra PS, Sterk PJ; GLUCOLD Study Group. Relapse in FEV1 Decline After Steroid Withdrawal in COPD. Chest. 2015 Aug;148(2):389-396. doi: 10.1378/chest.14-3091.
Kunz LI, Strebus J, Budulac SE, Lapperre TS, Sterk PJ, Postma DS, Mauad T, Timens W, Hiemstra PS; GLUCOLD (Groningen Leiden Universities Corticosteroids in Obstructive Lung Disease) Study Group. Inhaled steroids modulate extracellular matrix composition in bronchial biopsies of COPD patients: a randomized, controlled trial. PLoS One. 2013 May 7;8(5):e63430. doi: 10.1371/journal.pone.0063430. Print 2013.
Lapperre TS, Snoeck-Stroband JB, Gosman MM, Jansen DF, van Schadewijk A, Thiadens HA, Vonk JM, Boezen HM, Ten Hacken NH, Sont JK, Rabe KF, Kerstjens HA, Hiemstra PS, Timens W, Postma DS, Sterk PJ; Groningen Leiden Universities Corticosteroids in Obstructive Lung Disease Study Group. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009 Oct 20;151(8):517-27. doi: 10.7326/0003-4819-151-8-200910200-00004.
Lapperre TS, Sont JK, van Schadewijk A, Gosman MM, Postma DS, Bajema IM, Timens W, Mauad T, Hiemstra PS; GLUCOLD Study Group. Smoking cessation and bronchial epithelial remodelling in COPD: a cross-sectional study. Respir Res. 2007 Nov 26;8(1):85. doi: 10.1186/1465-9921-8-85.
Other Identifiers
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SER9804 / Glucold
Identifier Type: -
Identifier Source: secondary_id
SCO30001
Identifier Type: -
Identifier Source: org_study_id