Lisette I Z Kunz1, Dirkje S Postma2, Karin Klooster2, Thérese S Lapperre3, Judith M Vonk2, Jacob K Sont4, Huib A M Kerstjens2, Jiska B Snoeck-Stroband4, Pieter S Hiemstra5, Peter J Sterk6. 1. Department of Pulmonology, LUMC, Leiden, The Netherlands. Electronic address: L.I.Z.Kunz@lumc.nl. 2. Department of Pulmonary Medicine and Department of Epidemiology, UMCG, University of Groningen, Groningen, The Netherlands. 3. Department of Pulmonology, LUMC, Leiden, The Netherlands; Department of Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore. 4. Department of Medical Decision Making, LUMC, Leiden, The Netherlands. 5. Department of Pulmonology, LUMC, Leiden, The Netherlands. 6. Department of Respiratory Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Abstract
BACKGROUND: We previously observed that 30 months of inhaled corticosteroid (ICS) treatment can attenuate FEV1 decline in COPD, but it is unclear whether withdrawal induces a relapse. We hypothesized that FEV1 decline, airway hyperresponsiveness (AHR), and quality of life (QOL) deteriorate after ICS cessation even after prolonged use. METHODS:One hundred fourteen patients with moderate to severe COPD finished randomized 6-month or 30-month treatment with fluticasone (500 μg bid), 30-month treatment with fluticasone and salmeterol (500/50 μg bid), or placebo (first part of the Groningen and Leiden Universities Corticosteroids in Obstructive Lung Disease [GLUCOLD] study [GL1]). The subsequent 5 years, patients were prospectively followed annually, treated by their physician (GLUCOLD follow-up study [GL2]). Postbronchodilator FEV1, AHR, and QOL were initially recorded at baseline, at 30 months (GL1), and annually during GL2. Analysis was performed by linear mixed-effects models. RESULTS: Among 101 adherent patients during GL1, 79 patients started and 58 completed GL2. Patients using ICSs during GL1, but only using ICSs 0% to 50% of the time during GL2 (n = 56 of 79), had significantly accelerated annual FEV1 decline compared with GL1 (difference GL2-GL1 [95% CI]: 30-month treatment with fluticasone and salmeterol, -68 mL/y [-112 to -25], P = .002; 30-month treatment with fluticasone, -73 mL/y [-119 to -26], P = .002), accompanied by deterioration in AHR and QOL. CONCLUSIONS:ICS discontinuation after 30 months in COPD can worsen lung function decline, AHR, and QOL during 5-year follow-up. This suggests that ICS treatment lacks sustained disease-modifying effect after treatment cessation. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00158847; URL: www.clinicaltrials.gov.
RCT Entities:
BACKGROUND: We previously observed that 30 months of inhaled corticosteroid (ICS) treatment can attenuate FEV1 decline in COPD, but it is unclear whether withdrawal induces a relapse. We hypothesized that FEV1 decline, airway hyperresponsiveness (AHR), and quality of life (QOL) deteriorate after ICS cessation even after prolonged use. METHODS: One hundred fourteen patients with moderate to severe COPD finished randomized 6-month or 30-month treatment with fluticasone (500 μg bid), 30-month treatment with fluticasone and salmeterol (500/50 μg bid), or placebo (first part of the Groningen and Leiden Universities Corticosteroids in Obstructive Lung Disease [GLUCOLD] study [GL1]). The subsequent 5 years, patients were prospectively followed annually, treated by their physician (GLUCOLD follow-up study [GL2]). Postbronchodilator FEV1, AHR, and QOL were initially recorded at baseline, at 30 months (GL1), and annually during GL2. Analysis was performed by linear mixed-effects models. RESULTS: Among 101 adherent patients during GL1, 79 patients started and 58 completed GL2. Patients using ICSs during GL1, but only using ICSs 0% to 50% of the time during GL2 (n = 56 of 79), had significantly accelerated annual FEV1 decline compared with GL1 (difference GL2-GL1 [95% CI]: 30-month treatment with fluticasone and salmeterol, -68 mL/y [-112 to -25], P = .002; 30-month treatment with fluticasone, -73 mL/y [-119 to -26], P = .002), accompanied by deterioration in AHR and QOL. CONCLUSIONS:ICS discontinuation after 30 months in COPD can worsen lung function decline, AHR, and QOL during 5-year follow-up. This suggests that ICS treatment lacks sustained disease-modifying effect after treatment cessation. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00158847; URL: www.clinicaltrials.gov.
Authors: Didier Cataldo; Eric Derom; Giuseppe Liistro; Eric Marchand; Vincent Ninane; Rudi Peché; Hans Slabbynck; Walter Vincken; Wim Janssens Journal: Int J Chron Obstruct Pulmon Dis Date: 2018-07-05
Authors: Gary T Ferguson; Asif Shaikh; Kay Tetzlaff; Achim Mueller; Helgo Magnussen; Henrik Watz Journal: Int J Chron Obstruct Pulmon Dis Date: 2020-11-11