Modification Of Disease Outcome In COPD

NCT00158847 | Terminated Phase 4

• 2 other identifiers: SCO30001SER9804 / Glucold
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD inflammation sputum lung function biopsy

Outcome Measures

Primary Outcomes (1)

• Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.

Secondary Outcomes (1)

• Clinical: symptoms, exacerbations, quality of life, lung function, 6 min walking test. Inflammation: markers in sputum and BAL, profile of epithelial cells, remodeling.

Interventions

fluticasone 500 mcg DRUG

fluticasone 500 mcg + salmeterol 50 mcg DRUG

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients with \> 10 pack years.
• 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.

You may not qualify if:

• No oral corticosteroids 3 months prior to the study or maintenance treatment with corticostroids 6 months prior to the study.
• No history of asthma, lung diseases other than COPD, other diseases likely to interfere with the study.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Academisch Ziekenhuis Groningen: collaborator
• The Netherlands Asthma Foundation: collaborator
• Netherlands Organisation for Scientific Research: collaborator
• GlaxoSmithKline: collaborator

Study Sites (2)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Related Publications (10)

• 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.

  PMID: 15172889 BACKGROUND

• 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.

  PMID: 40739568 DERIVED

• 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.

  PMID: 35118915 DERIVED

• 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.

  PMID: 33060632 DERIVED

• 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.

  PMID: 26696093 DERIVED

• 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.

  PMID: 26659582 DERIVED

• 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.

  PMID: 25836351 DERIVED

• 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.

  PMID: 23667615 DERIVED

• 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.

  PMID: 19841453 DERIVED

• 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.

  PMID: 18039368 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Peter J. Sterk, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2000
• Study Completion: May 1, 2005
• Last Updated: January 20, 2006

Record last verified: 2005-01

Locations

NL (2)